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Regulatory Harmonization-Convergence [clear filter]
Sunday, June 26
 

9:00am EDT

#43: Risk Management and Safety Communication Strategies
Limited Capacity seats available

Component Type: Tutorial
CE: ACPE 6.50 Knowledge UAN: 0286-0000-16-505-L04-P; CME 6.50; IACET 6.50; RN 6.50

An additional registration fee is required for all preconference tutorials. Register today for this tutorial.

Risk communication is increasingly important to everyone involved in our health care system, especially the patients whose lives we strive to improve. This tutorial will look at current initiatives and new strategies to advance the safe use of drugs. The current status and future of Risk Evaluation and Mitigation Strategies (REMS) in the US will be discussed, and compared with Risk Management Plans in Europe and Japan.

What You Will Learn:
• Current state of risk communication in the United States
• Health literacy, risk perception, and other safety communication issues
• New strategies to improve understanding of drug safety concerns among health care providers and to promote better communication to patients
• The development of risk evaluation and mitigation strategies (REMS) in the US
• How US REMS with risk management plans compare with those of Europe and Japan
• The importance of good communication during a crisis situation.

Who should attend?

This tutorial is designed for professionals who work in clinical safety and pharmacovigilance, regulatory affairs, medical writing, and marketing and communications.

Learning Objectives

• Describe current risk communication strategies;
• Discuss the development of REMS in the US;
• Explain new methods to improve the proper use of medicines to maximize patient benefit and minimize risk;
• Discuss the future of drug safety and risk communication especially during a crisis situation.


Speakers
avatar for Nancy Smith

Nancy Smith

Adjunct Professor, Temple University, FDA Alumni
Nancy Smith, PhD, retired from the FDA after almost 25 years in the Center for Drug Evaluation and Research. Nancy is past-Chair of the Biopharmaceutical Section of the American Statistical Association, and she served as a DIA board member of from 2002-2008. She was Chair of the DIA... Read More →


Sunday June 26, 2016 9:00am - 5:00pm EDT
113B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Preconference Tutorial, Tutorial |   Trk 14: Clin Safety-PV, Tutorial

1:00pm EDT

#34: Ethical Issues in Clinical Trials
Limited Capacity seats available

Component Type: Tutorial
CE: ACPE 3.25 Knowledge UAN: 0286-0000-16-512-L04-P; CME 3.25; IACET 3.25; RN 3.25

An additional registration fee is required for all preconference tutorials. Register today for this tutorial.

This tutorial will provide an overview of the various ethical considerations associated with conducting clinical trials, including the history of ethical principles - Nuremburg Conventions, Declaration of Helsinki, The Belmont Report, and ICH. Topics will include obtaining ethics committee and regulatory authority clearance, subject informed consent, investigator conflict-of-interest, issues of fraud, authorship, and ensuring subject safety and well-being. In addition, consideration will be given to conducting studies in emerging economy populations where fair distribution of risks and benefits come into play. It will become evident, through case examples, that these issues are not always black-and-white, and that the situation in which these issues are considered result in many shades of gray.

Who should attend?

This tutorial is designed for pharmaceutical company clinical operations staff, clinical trial site investigators and study coordinators, ethicists, regulators and regulatory affairs staff.

Learning Objectives

• Discuss the foundations of ethics;
• Explain how ethical decisions may be influenced by context and experience;
• Discuss the viewpoint of the clinical study subject when educating clinical study site staff about ethical considerations.


Speakers
avatar for Art Gertel

Art Gertel

President and Principal Consultant, MedSciCom, LLC, United States
Dr. Gertel has more than 40 years of experience in the pharmaceutical industry in virtually all phases of pharmaceutical drug research and development, from preclinical pathology/toxicology to registrational clinical trials, post-marketing trials, project management, and market support... Read More →


Sunday June 26, 2016 1:00pm - 4:30pm EDT
104AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Preconference Tutorial, Tutorial |   Trk 08: Reg Affairs, Tutorial
 
Monday, June 27
 

8:30am EDT

#111: Global Regulatory Harmonization in Asia: Is a New Trend Occurring?
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-551-L04-P; CME 1.25; IACET 1.25; RN 1.25

Recently we have seen increased efforts of Asian regulatory harmonization. Hear speakers from Asian agencies and industry and learn how they try to collaborate and harmonize regulations to enable more efficient drug development in this emerging region.

Learning Objectives

Discuss recent changes in drug development regulations in Asia; Describe the Asian regulation trend relating to harmonization with ICH and other global initiatives; Identify how the industry and regulatory agencies collaborate with each other for better and faster drug development by reviewing recent examples of global drug development utilizing multiregional clinical trials including Asia.

Chair

Akio Uemura, PhD

Speaker

Update on Clinical and Regulatory Environment for Drug Development in Korea
Min Soo Park

Rapidly Changing Regulatory Landscape in China
Dan Zhang

Impacts of ICH E17 Guideline in Asian Drug Development
Yoshiaki Uyama, PhD



Chair
avatar for Akio Uemura

Akio Uemura

Executive Director, Head of Japan Development, Allergan Japan K.K.
1996: Head of biosciences lab, Mochida Pharmaceutical, 2000: Director, project management, EL Japan, 2004: Clinical phase global project manager, Eli Lilly, 2007: Director, regulatory policy, liaison and intelligence, EL Japan. 2011: Head of Japan Regulatory Affairs, Allergan Japan... Read More →

Speakers
avatar for Min Soo Park

Min Soo Park

Chair, KCGI
Min Soo Park is a physician, trained specialist and Professor in Pediatrics (Neonatology) and Clinical Pharmacology. He received MSc in Clinical Pharmacology at Univ of Aberdeen, UK, and Ph.D. in Medicine at Ajou University, Korea. He served as VP of KoNECT and is in charge of clinical... Read More →
avatar for Yoshiaki Uyama

Yoshiaki Uyama

Director, Office of Medical Informatics and Epidemiology, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Yoshiaki Uyama, PhD, is Director, Office of Medical Informatics and Epidemiology, for the Pharmaceuticals & Medical Devices Agency (PMDA), Japan. His experience in the safety review and assessment of new drugs for PMDA includes serving as the Review Director; as International Conference... Read More →
avatar for Dan Zhang

Dan Zhang

Executive Chairman, Fountain Medical Development Ltd. (FMD)
Dr. Dan Zhang, the Executive Chairman of Fountain Medical Development, has more than 15 years of drug development experience. Previously, Dr. Zhang was the Head of Clinical Development and Global Safety Assessment at Sigma-Tau Research Inc., Vice President at the Quintiles Transnational... Read More →


Monday June 27, 2016 8:30am - 9:45am EDT
204B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 08: Reg Affairs, Session

10:45am EDT

#123: Global Clinical Trials: Innovative Approaches to Clinical Trials in Japan, India, and Latin America
Limited Capacity seats available

Component Type: Symposium
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

In this symposium, the presenters are examining various innovative approaches to and requirements for conducting clinical trials in Japan, India, and Latin America, as well as how their respective regulatory environments have contributed to fostering innovation, product development, and clinical research.

Learning Objectives

Discuss the requirements for conducting clinical trials in Japan, India and Latin America; Share insights into innovative regulatory approaches that could impact clinical studies in these regions; Describe factors one needs to consider when conducting ethno-bridging studies outside the United States.

Chair

Larry A. Blankstein, PhD

Speaker

Issues and Solutions When Conducting Complex Caucasian Clinical Studies in Japan
Andrew Melli

Clinical Trials in India: An Update on Current Status
Charu Gautam, MD

Clinical Research in Latin America: Trends, Challenges and New Opportunities
Maria João Queiroz, MD



Chair
avatar for Larry Blankstein

Larry Blankstein

Consultant, Clinical Development, Blankstein Consulting Group
Dr. Larry Blankstein is an independent Senior Consultant to the Pharmaceutical and Biotechnology industry. He has over twenty-two years experience in drug development strategy, clinical operations and mergers and acquisitions. He received his Ph.D. degree in Biology from Wesleyan... Read More →

Speakers
avatar for Charu Gautam

Charu Gautam

Senior Medical Director, IQVIA
Charu Gautam is a Physician with over 20 years experience in research and academics. Been associated with leading companies in India to lead the clinical operations and medical teams. Qualified as MBBS, MD and a board certification in Clinical Pharmacology . She is also a lead faculty... Read More →
avatar for Andrew Melli

Andrew Melli

Senior Manager, SOUSEIKAI Global Clinical Research Center
Andrew Melli is the Senior Manager of Global Clinical Development at SOUSEIKAI Global Clinical Research Center, serving as both liaison for international business development and investment, as well as an active member of the clinical trial team. It is his hope to help bridge the... Read More →
avatar for Maria João Queiroz

Maria João Queiroz

Global CEO, Eurotrials Scientific Consultants
More than two decades at executive leadership positions in the pharmaceutical industry, Founding Member & CEO at Eurotrials, a CRO in Europe and Latin America. With a Degree in Medicine, specialization in Immunohematology and a post-graduation in Pharmaceutical Medicine. Has active... Read More →


Monday June 27, 2016 10:45am - 12:00pm EDT
113B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 01: Clinical Operations, Symposium

10:45am EDT

#133: Take Advantage of Global Expedited Pathways: Breakthrough, Sakigake, PRIME!
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-543-L04-P; CME 1.25; IACET 1.25; RN 1.25

The Breakthrough Designation (US), PRIME (Europe), and Sakigake (Japan) aim to reduce overall drug development times for certain products. This session shows you how to take advantage of these and other global expedited development programs.

Learning Objectives

Compare and contrast global expedited development pathways; Discuss ways to adapt global development programs to take advantage of all expedited pathways.

Chair

Khyati Roberts, RPh

Speaker

The New Japanese “Sakigake” Strategy for Accelerated Development and Approval: Status, Procedure, and Prospects for Industry
Alberto Grignolo, PhD

Strategies for Using the New European PRIME Pathway
Sharon N. Olmstead



Chair
avatar for Khyati Roberts

Khyati Roberts

Head US/Canada, Regulatory Policy and Intelligence, AbbVie, Inc.
Khyati leads regulatory policy advocacy efforts for the U.S. and Canada and coordiantes international harmonization efforts. She joined AbbVie in 2012 and has nearly 30 years of regulatory experience. Khyati has also provided regulatory advice to the biopharmaceutical industry on... Read More →

Speakers
avatar for Alberto Grignolo

Alberto Grignolo

Corporate Vice President, Parexel, United States
Alberto Grignolo, PhD is a Corporate Vice President at Parexel, and established the firm's Japan Consulting Services during a two-year assignment in Tokyo. Dr. Grignolo has served as an adviser on human subject protection in clinical trials to the Institute of Medicine of the National... Read More →
avatar for Sharon Olmstead

Sharon Olmstead

Global Head, Development and Regulatory Policy, Novartis Pharmaceuticals Corporation
Sharon Olmstead is the Global Head of Development & Regulatory Policy at Novartis. She first joined Novartis in 1997, in their FDA Liaison Office. From 2002 until returning to Novartis in 2011, she held leadership positions at Merck, Schering-Plough, and Pharmacia. She built a foundation... Read More →


Monday June 27, 2016 10:45am - 12:00pm EDT
201B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
 
Tuesday, June 28
 

10:30am EDT

#220: Regulatory Changes in China and the Impact to Global Drug Development Planning
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: CME 1.00; IACET 1.00; RN 1.00

In August 2015, the Chinese Food and Drug Administration (CFDA) issued extensive changes to drug reviews and approvals. It has effectively redefined the definition of a new drug and the approval process for any new drug development as well as generics. While China is becoming the second largest pharmaceutical market, it would benefit all firms to carefully review and digest the impact of such a change to their global drug development planning; in turn, this allows them to take advantage of this change and properly adapt. This session will highlight the changes that have a direct impact on the clinical development strategy and share case studies with the audience to illustrate the best approach in handling these regulatory changes.

Learning Objectives

Recognize changes made by the Chinese Food and Drug Administration to drug reviews and approvals; Identify how to best leverage these changes for your new drug developments and generics.

Chair

Dan Zhang

Speaker

Innovative Biopharmaceutical Drug Development in China: Trends and Transformations
Helena Zhang

Regulatory Changes in China
Feng Yi

Outline of Reforming IND/NDA Practice in China
Fudong An



Chair
avatar for Dan Zhang

Dan Zhang

Executive Chairman, Fountain Medical Development Ltd. (FMD)
Dr. Dan Zhang, the Executive Chairman of Fountain Medical Development, has more than 15 years of drug development experience. Previously, Dr. Zhang was the Head of Clinical Development and Global Safety Assessment at Sigma-Tau Research Inc., Vice President at the Quintiles Transnational... Read More →

Speakers
avatar for Feng  Yi

Feng Yi

Former Assistant to the Director-General, CFDA; SVP, Medical and Reg Affairs, Fountain (Beijing) Medical Technology Development Co., Ltd.
avatar for Helena Zhang

Helena Zhang

Senior Director and Chief Medical Officer, Quintiles
Dr. Helena Zhang, MD. MBA is Senior Director and Chief Medical Officer for Quintiles in the Greater China region. In this role she provides medical and ethical leadership of projects conducted by Quintiles in China. She enhances the strategic partnerships with top hospitals, Key Opinion... Read More →


Tuesday June 28, 2016 10:30am - 11:30am EDT
109AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 08: Reg Affairs, Session

10:30am EDT

#227: Unique Global Regulatory Considerations and Drug Development Incentives in Rare Disease and Orphan Drug Development
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-16-590-L01-P; CME 1.00; IACET 1.00; RN 1.00

Early consideration of the issues unique to rare disease development allows sponsors to proactively and adequately identify/address them during development and to have productive interactions with Health Authorities (HA). Unique program elements will be compared and contrasted, focusing on regulatory aspects of rare/orphan development and early HA consult to create successful programs that address the particular challenges. We will also discuss how to strategically take advantage of the various US and EU incentives such as market exclusivity, tax reduction, and expedited review process, as well as grants to facilitate the development of orphan drugs, to enhance orphan drug development.

Learning Objectives

Discuss the regulatory requirements unique to the global development of rare disease and orphan drugs, including the regulatory implications; Explain the regulatory considerations to create efficient, feasible, and sufficient rare disease and orphan drug programs; Summarize regulations regarding orphan drug designations in the US and EU; Discuss and demonstrate how drug developers can take advantage of the regulators' incentives to optimize their investment in orphan drug development.

Chair

Maureen Smith

Speaker

Maximizing the Advantages of US and EU Orphan Drug Designation Incentives
Irene Pan

Global Regulatory Considerations in Rare Disease and Orphan Drug Development: When Patients Are Waiting and Everyday Counts
Lauren Peterson Tornetta



Chair
avatar for Maureen Smith

Maureen Smith

Patient Advocate / Secretary, Canadian Organization For Rare Disorders (CORD)
Maureen Smith’s M.Ed. (Educational Psychology) interest in patient advocacy stems from a rare disease diagnosis at the age of 8. She is the Secretary of the Canadian Organization for Rare Disorders (CORD), co-chair of the Rare/Orphan Disease program track for the Drug Information... Read More →

Speakers
IP

Irene Pan

Senior Research Scientist, UBC: An Express Scripts Company
Irene Pan, MSc, is a Senior Research Scientist with UBC: An Express Scripts Company. With over 12 years of clinical research experience, Ms. Pan has conducted numerous studies in a wide range of therapeutic indications including ophthalmology, neurology, cardiology, oncology and respiratory... Read More →
avatar for Lauren Tornetta

Lauren Tornetta

Director, Global Regulatory Affairs, Pfizer Inc
15 years of experience across public and government (FDA) sectors with an MBA in biotechnology and an MS in biochemistry. Global experience leading reg strategy with drugs (NCE, line extensions, drug: drug codev, biologic products, and combination products [drug: device]), in all... Read More →


Tuesday June 28, 2016 10:30am - 11:30am EDT
103C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 17: Rare-Orphan Diseases, Session

10:30am EDT

#223: Global Harmonization: Current ICH Quality Initiatives
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-567-L04-P; CME 1.25; IACET 1.25; RN 1.25

The concepts described in ICH Q8, Q9, Q10, and Q11 provide opportunities for a more science- and risk-based approach for developing medicinal products. It is important to have a harmonized implementation approach of these guidelines within and outside ICH regions. In addition, it is critical to focus on the commercial phase of product life cycle to be able to realize the full benefits of these guidelines. This session will discuss current ICH activities including ICH Q12 and ICH Q11 IWG. Industry speakers will share their perspectives on these initiatives and propose ways to address current technical and regulatory challenges.

Learning Objectives

Discuss current ICH activities; Examine different ways to approach technical and regulatory challenges; Recognize the importance of the guidelines within and outside of the ICH regions.

Chair

Moheb M. Nasr, PhD, MS

Speaker

A Holistic Approach for Global Management of Manufacturing Changes
Romuald Braun, MSc

ICH Q11 IWG Update
Timothy J.N. Watson, PhD

What Is Needed to Make ICH Q12 a True Transformational Guideline?
Roger Nosal



Chair
avatar for Moheb Nasr

Moheb Nasr

Vice President, CMC Regulatory Strategy, GlaxoSmithKline
Dr. Nasr is responsible for the development and the execution of CMC regulatory strategy at GSK. Prior to joining GSK, he spent over 22 yrs at FDA and established and led the Office of New Drug Quality Assessment (ONDQA). Dr. Nasr was instrumental in the development of QbD concept... Read More →

Speakers
avatar for Romuald Braun

Romuald Braun

Managing Director, uanotau gmbh
Since 1992 Romuald has been working in roles related to Compliance, Document Management, Content Management in Life Sciences industry. He played roles on client side and in consulting, in delivery and in sales, in project roles and in line responsibility. He worked in client server... Read More →
avatar for Roger Nosal

Roger Nosal

Vice President, Head of Global CMC, Pfizer Inc, United States
Roger Nosal is Vice President & Head of Global Chemistry, Manufacturing & Controls at Pfizer. Roger has contributed to the evolution of Quality by Design & has advocated for global regulatory harmonization through several ICH, PhRMA, ISPE, PQRI, AAPS, IFPAC, ACS & DIA technical committees... Read More →
avatar for Timothy Watson

Timothy Watson

Executive Director, Pfizer Inc
Tim was one of the PhRMA expert working group (EWG) members on the ICHQ11 regulatory guidance document for drug substance, and the current Rapporteur for the ICHQ11 Starting Material IWG. He is also served on the ICHQ7 IWG Q&A team, ICHQ3C EWG, and supporting many other ICH efforts... Read More →


Tuesday June 28, 2016 10:30am - 11:45am EDT
112AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 12: Pharm Quality, Session

10:30am EDT

#226: The Global Conundrum: Herding Cats - Identifying Risk Across Pharmacovigilance Networks and Seeking Simplicity in Multi-Country Pharmacovigilance Activities
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

As pharmaceutical companies seek ways to centralize and better coordinate with affiliates, some pharmacovigilance activities, such as interfacing with health care professional and patients, must be managed locally. Dealing with these activities across multiple countries can be extremely complicated, and companies must find ways to simplify and improve their processes. In this forum, we will explore the Pharmacovigilance (PV) Affiliate Network from both corporate and local perspectives and review case studies of issues faced by companies of all sizes, from start-up to multi-national. In addition, we will present an approach to clarifying the current affiliate situation using an affiliate’s survey tool as well as available in-house data sources. We will also demonstrate a risk-assessment approach that can be applied to generate a clear view of systemic risk (exposure across all or many affiliates) and unique risks (exposure specific to one particular or a few local affiliates). Finally we will highlight methods to streamline PV affiliate processes and the benefits this approach provides to the enterprise. A panel discussion following the presentations offers attendees the opportunity to ask questions and to discuss ideas about global PV affiliate management with the speakers.

Learning Objectives

Assess similarities and differences between regions including recognizing peculiarities in present day international pharmacovigilance scenarios; Describe a methodology for identifying and assessing systemic and unique risks across the affiliate network; Identify the potential benefits from implementation of an affiliate risk-reduction and simplification exercise on portfolio management; Evaluate the company needs and formulate high-impact solutions to minimize risk and improve processes.

Chair

Hershell William Thompson

Speaker

Managing a PV Affiliates Network: The Challenges and Considerations in Maintaining Oversight and In-Country Connections
Lesia Tontisakis, BSN

A Global Conundrum: Seeking Simplicity in Multi-Country Pharmacovigilance Activities
Marco Anelli



Chair
avatar for Hershell Thompson

Hershell Thompson

Managing Consultant, Navitas Life Sciences, Inc.
Hershell is a Managing Consultant with Navitas Life Sciences and has with over 25 years of medicines development and change management experience. He has extensive operational experience in phase I-IV clinical trials, health outcomes, pharmacovigilance and medical devices. He was... Read More →

Speakers
avatar for Marco Anelli

Marco Anelli

Head of Pharmacovigilance and Medical Affairs Advisory Services, Productlife Group
Marco Anelli is Head of Pharmacovigilance and Medical Affairs Advisory Services at ProductLife Group . In the past 25 years he has worked in Phase I-IV and PV. In addition, Marco is also QPPV and has prepared and signed over 200 non-clinical and clinical overviews and summaries... Read More →
avatar for Lesia Tontisakis

Lesia Tontisakis

Director, Pharmacovigilance, Global Patient Safety and Epidemiology, Allergan
Lesia Tontisakis joined Allergan in 2011 leading key Safety Operations functions ensuring global quality & compliance targets are met. Key responsibilities include QMS oversight, compliance, Inspection Readiness, PVA Management, Training and Vendor Oversight (ICSR management and Affiliate... Read More →


Tuesday June 28, 2016 10:30am - 11:45am EDT
113C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 14: Clin Safety-PV, Forum

10:30am EDT

#225: One Size Does Not Fit All: Best Practices for Right-Sized Signal Management Systems
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-600-L04-P; CME 1.25; IACET 1.25; RN 1.25

The requirement to properly plan, track, and manage signals from all sources has never been greater, and we are seeing an increasing focus of inspectors on companies' signaling strategies. This session describes cutting edge research from a local and a global perspective and will aid companies in designing a fit-for-purpose signal detection and management strategy for their product portfolios. This sesion will utilize real life examples in the presentation.

Learning Objectives

Describe signal management regulatory requirements in the EU, US, and other regions; Discuss how the basic principles of modern signal detection and management systems can be adapted to fit various-sized portfolios while ensuring quality is optimized; Recall developments in advanced signaling informatics.

Chair

Deirdre McCarthy, MS

Speaker

What Is the Utility of GIS Technology in the Postmarket Setting?
Henry "Skip" Francis

Practical Tools for Signal Management: How Do You Overcome Challenges and Meet the Regulatory Needs of Pharmacovigilance?
Shelley Gandhi, MS

Global Signal Detection with Regional Relevance: Development and Field Testing of Surveillance Strategies for the Emerging Indian Market
Ola Caster, PhD



Chair
avatar for Deirdre McCarthy

Deirdre McCarthy

Senior Benefit Risk Management Director, Quintiles Inc.
Over 15 years in PV, spanning CRO, regulatory authority and company. Areas of special interest are EU post-marketing safety systems & product benefit-risk management. Adjunct Lecturer in international PV at Tufts University School of Public Health and Community Medicine in Boston... Read More →

Speakers
avatar for Ola Caster

Ola Caster

Senior Researcher, Uppsala Monitoring Centre
Ola Caster is Senior Researcher at the Uppsala Monitoring Centre and affiliated with the Department of Computer and Systems Sciences, Stockholm University. He has nearly ten years’ experience from research and development in global pharmacovigilance, with formal qualifications PhD... Read More →
avatar for Henry Francis

Henry Francis

Director for Data Mining and Informatics Evaluation and Research, OTS, CDER, FDA
Dr. Francis is the Director of the Data mining and Informatics Evaluation and Research Group in the Office of Translational Sciences, CDER, FDA.In that capacity he directs a trans-disciplinary group of senior sciences to test, create and operate data analysis program facilitating... Read More →
avatar for Shelley Gandhi

Shelley Gandhi

Strategic Advisor, Pharmacovigilance and Drug Safety, NDA Group
Shelley is an experienced and highly motivated pharmacovigilance and risk management expert, with an international reputation in her field, specialising in delivering global safety solutions including safety governance models. Former senior manager at MHRA for over 19 years and represented... Read More →


Tuesday June 28, 2016 10:30am - 11:45am EDT
113B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 14: Clin Safety/PV, Session

2:00pm EDT

#238: Prescription Drug Marketing Regulatory Primer
Limited Capacity seats available

Component Type: Session
Level: Basic
CE: ACPE 1.25 Application UAN: 0286-0000-16-528-L04-P; CME 1.25; IACET 1.25; RN 1.25

This interactive workshop will provide a basic introduction to the regulation of prescription drug advertising and promotion. It will cover such important information as fair balance, required claim support, comparative claims, preapproval activities, and medical conventions.

Learning Objectives

Discuss important environmental forces and agencies impacting the regulation of prescription drug promotion; Apply advertising and promotional regulations to advertising/marketing materials; Explain the importance of reviewing FDA regulatory letters as they apply to these regulatory decisions.

Chair

Lucy Rose, MBA

Speaker

FDA Perspective
Thomas W. Abrams



Chair
avatar for Lucy Rose

Lucy Rose

President, Lucy Rose and Associates, LLC

Speakers
avatar for Thomas Abrams

Thomas Abrams

Director, Office of Prescription Drug Promotion, OMP, CDER, FDA
Thomas Abrams is the Director of the Office of Prescription Drug Promotion (formerly the Division of Drug Marketing, Advertising, and Communications (DDMAC)), Food and Drug Administration. He joined FDA as a reviewer in DDMAC. Prior to joining FDA, Mr. Abrams worked in pharmaceutical... Read More →


Tuesday June 28, 2016 2:00pm - 3:15pm EDT
107AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 05: Reg of Prod Adv/Mkting, Session

2:00pm EDT

#241: Disease Interception: Shifting the Paradigm from Treatment to Prevention of Disease
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-547-L01-P; CME 1.25; IACET 1.25; RN 1.25

Disease interception focuses on the development of medicines that stop or delay disease progression for patients at risk or asymptomatic within the disease continuum. Learn as regulators and payers share perspectives in this new drug development space.

Learning Objectives

Discuss the regulatory and implementation challenges to innovation in disease interception; Propose solutions to regulatory challenges to innovation for disease interception therapies; Assess the benefit and risk framework and value of disease interception therapies.

Chair

Karin Van Baelen, PharmD

Speaker

FDA Perspective
Ellis Unger, MD

EU Perspective
Hans-Georg Eichler

Payer Perspective
Sean R. Tunis, MD, MSc



Chair
avatar for Karin Van Baelen

Karin Van Baelen

Head, Global Regulatory Affairs, Janssen Pharmaceutical Companies of Johnson & Johnson
Karin is leading the Global Regulatory Affairs organization at Janssen. She facilitates the relationship between the Janssen pharmaceutical companies and global health authorities, influencing and interpreting global regulatory requirements and enabling our companies to meet those... Read More →

Speakers
avatar for Hans-Georg Eichler

Hans-Georg Eichler

Senior Medical Officer, European Medicines Agency, European Union
Dr. Eichler is responsible for coordinating activities between the European Medicine Agency's (EMA) scientific committees and giving advice on scientific and public health issues. Prior to joining EMA, Dr. Eichler was professor and chair of clinical pharmacology and vice-rector at... Read More →
avatar for Sean Tunis

Sean Tunis

Senior Strategic Advisor, Center For Medical Technology Policy (CMTP)
Sean Tunis, MD, MSc, is Founder and Senior Strategic Advisor of the Center for Medical Technology Policy, an independent, non-profit organization that provides a neutral platform for multi-stakeholder collaborations that promote high value innovation by improving the quality, relevance... Read More →
avatar for Ellis Unger

Ellis Unger

Director, Office of Drug Evaluation I, OND, CDER, FDA
Ellis F. Unger is the Director, Office of Drug Evaluation-I, Office of New Drugs, Center for Drug Evaluation and Research, FDA. His Office oversees the regulation of drugs for cardiovascular, renal, neurological, and psychiatric disorders. Dr. Unger is a board-certified internist... Read More →


Tuesday June 28, 2016 2:00pm - 3:15pm EDT
201B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 08: Reg Affairs, Forum

4:00pm EDT

#261: Marketing After Amarin and Pacira
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-529-L04-P; CME 1.25; IACET 1.25; RN 1.25

FDA regulation of off-label communications by industry sponsors has been under extraordinary scrutiny the past several years, especially since the Supreme Court decision in IMS v. Sorrell and the federal appeals court decision in US v. Caronia. The issue came to a head in the federal district court in New York city last summer that resulted in the decision against FDA in Amarin v. FDA and a similar challenge by Pacira Pharma against FDA. Meanwhile, the FDA has promised regulatory guidances on aspects of off-label communication policy and the US House of Representatives has passed related legislation. This session will review and assess the regulatory importance of these events, including any late breaking news from Congress, the Courts, and the FDA.

Learning Objectives

Identify many of the details of the Amarin and Pacira cases including how they may effect ongoing decision making in Congress, the courts, and FDA; Describe existing and emerging guidance from FDA and how it may change regulatory policy.

Chair

John Kamp

Speaker

Life After Amarin and Pacira: Understanding Off-Label Promotion in 2016
Alexander Varond, JD

Panelist
Jeffrey K. Francer

Panelist
Kellie B. Combs, JD



Chair
avatar for John Kamp

John Kamp

Executive Director, Coalition For Healthcare Communication
Dr. John F. Kamp is Executive Director of the Coalition for Healthcare Communication, a medical marketing trade association with offices in New York City and Washington, DC. He is also Consulting Counsel with the law firm Wiley Rein LLP, and is a widely respected advocate for First... Read More →

Speakers
avatar for Kellie Combs

Kellie Combs

Partner, Ropes & Gray LLP
Kellie Combs is a Partner in the Washington, DC office of Ropes and Gray, where she advises pharmaceutical, biotech, and medical device companies on a range of FDA regulatory issues, including promotional compliance, lifecycle management, and regulation of clinical research. She serves... Read More →
avatar for Jeffrey Francer

Jeffrey Francer

Vice President and Senior Counsel, Pharmaceutical Research and Manufacturers of America (PhRMA)
Jeff Francer is Assistant General Counsel of the Pharmaceutical Research and Manufacturers of America (PhRMA), where he provides advice and advocacy to the Association and its member companies on FDA regulatory and policy matters.
avatar for Alexander Varond

Alexander Varond

Associate, Goodwin Procter LLP
Alexander J. Varond works on drug development and medical devices, advertising and promotion, and enforcement issues. He counsels clients on drug development matters such as clinical trial design, REMS, orphan drug designation, formal dispute resolution, and patent and exclusivity... Read More →


Tuesday June 28, 2016 4:00pm - 5:15pm EDT
107AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 05: Reg of Prod Adv-Mkting, Session
 
Wednesday, June 29
 

10:30am EDT

#327: FDA–Health Canada Regulatory Cooperation Council Town Hall
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: CME 1.00; IACET 1.00; RN 1.00

The Regulatory Cooperation Council (RCC) was created in 2011 to develop smarter and more efficient and effective approaches to regulatory cooperation. FDA and Health Canada will highlight their work under RCC phase 2 and request stakeholder input on their current initiatives.

Learning Objectives

Discuss FDA and Health Canada Regulatory Cooperation Council (RCC) priority areas over the next two years; Identify areas for stakeholders to contribute to the RCC process.

Chair

Sema D. Hashemi, MSc

Speaker

Panelist
Sema D. Hashemi, MSc

Panelist
Ed Morgan



Chair
SH

Sema Hashemi

Director, Office of Regional and Country Affairs, OIP, OC, FDA
Ms. Hashemi has made significant contributions to FDA, having worked for the Agency since 1998 and serving in OIP for over 15 years in a variety of positions including Acting Director, Asia-Pacific Office; Acting Deputy Country Director China Office in Beijing; Deputy Director, ORCA... Read More →

Speakers
avatar for Ed Morgan

Ed Morgan

Director General, Policy, Planning and International Affairs Directorate, HPFB, Health Canada
In this position, Ed oversees regulatory policy development for health products and food, and provides strategic advice on advancing horizontal health policy and international agendas. Before joining Health Canada, Ed was Director of Operations for the Operations Committee of Cabinet... Read More →


Wednesday June 29, 2016 10:30am - 11:30am EDT
201C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 18: Global Regulatory, Session

2:00pm EDT

#343: Strategies, Enablers, and Barriers to Medicine Development in the Emerging Markets: The 2025 Global Regulatory Landscape
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-546-L04-P; CME 1.25; IACET 1.25; RN 1.25

Companies’ global development strategies and the competency of many maturing regulatory authorities are evolving. Which practices and processes will lead to an optimal future regulatory environment that expedite availability of new medicines?

Learning Objectives

Identify current global development and submission strategies for new medicines; Describe potential changes to the global regulatory landscape over the next ten years and realistic scenarios for regulatory review as medicines regulation evolves based on regulatory science; Discuss current and future regulatory barriers to global development and licensing and possible potential solutions.

Chair

Prisha Patel, MSc

Speaker

Industry Perspective
Joseph C. Scheeren, PharmD

WHO Perspective on Medicines Development in the Emerging Markets
Mike Ward



Chair
PP

Prisha Patel

Manager, Global Development Programme, Centre For Innovation In Regulatory Science (CIRS)
Prisha Patel is the Manager for the Global Development programme at the Centre for Innovation in Regulatory Science (CIRS), London, focusing on emerging markets. Her responsibilities include managing the emerging markets industry benchmarking and agency benchmarking projects and working... Read More →

Speakers
avatar for Joseph Scheeren

Joseph Scheeren

Senior Vice President, Head Regulatory Affairs, Pharma and Consumer Health, Bayer
Joseph Scheeren, Pharm.D. is Senior Vice President, Global Head of Regulatory Affairs Pharma & Consumer Health at Bayer. He has 30+ yrs exp. as Global Regulatory Affairs professional (France, Germany, Switzerland, US & China). He is an active member of the DIA Board of Directors... Read More →
avatar for Mike Ward

Mike Ward

Coordinator, Regulatory Systems Strengthening, EMP, World Health Organization (WHO)
Mike Ward is Coordinator of the Regulatory System Strengthening Team, Department of Essential Medicines and Health Technologies, Health Systems and Innovation Cluster, WHO Headquarters; he joined WHO as the Coordinator, Prequalification Team, in this same Department. He previously... Read More →


Wednesday June 29, 2016 2:00pm - 3:15pm EDT
201B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 08: Reg Affairs, Session

2:00pm EDT

#347: Global Harmonization: Non-ICH Regions
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

Multinational pharmaceutical companies generally manufacture the same product the same way for every market, region, and patient around the world. This session will discuss how, in the emerging markets, divergent, nonscientific, regulatory standards are proliferating. Increased global divergence in regulatory requirements and review times unnecessarily increases manufacturing costs, complicates the supply chain, hinders science and risk-based approaches, increases collective regulatory burden, reduces continuous improvement and innovation, and delays delivery of medicines to patients.

Learning Objectives

Discuss the regulatory landscape in Latin America compared to ICH regions; Describe an industry perspective on science/risk-based life cycle management; Identify regulator perspectives on life cycle management challenges.

Chair

Annie W Sturgess, PhD

Speaker

The Challenges Handling Postapproval Changes in Latin America
Maria Cristina Mota, MBA

The New Postapproval Regulations from ANVISA
Ivone Takenaka

Opportunities for Improved Access to Safe and Efficient Medicines
Maria Guazzaroni Jacobs, PhD



Chair
AS

Annie Sturgess

Vice President, Global Regulatory Sciences, CMC, Bristol-Myers Squibb Company

Speakers
avatar for Maria Guazzaroni Jacobs

Maria Guazzaroni Jacobs

Director, Quality and Regulatory Policy (QRP), Pfizer Inc
Maria has 30+ years of Pharmaceutical industry experience mainly in Quality.With Pfizer since 1991; she managed analytical laboratories, including the Quality Control Laboratories, and was the Brooklyn Site Quality Operations Director prior to assuming a Center position. Current... Read More →
avatar for Maria Cristina Mota Pina

Maria Cristina Mota Pina

Director, Scientific Regulatory Policy and Intelligence - Latin America, AbbVie, Inc.
Cristina is currently Director at AbbVie where she coordinates regulatory policy and intelligence activities for Latin America. Cristina worked for Boehringer Ingelheim for 13 years in different roles including Quality, Validation and Regulatory Affairs. Cristina attended Universidad... Read More →
avatar for Ivone Takenaka

Ivone Takenaka

Associate Director, GRSB-CMC and LATCAN Reg Expert, Bristol-Myers Squibb Company
Ivone Takenaka, Ph.D. is an Associate Director in Global Regulatory Affairs-CMC, and is the LA-Canada Regional Expert at Bristol-Myers Squibb Co. She earned her Ph.D. and MSc Degrees in Molecular Biology & Biochemistry from the University of Connecticut, CT; and MSc in QA&RA from... Read More →


Wednesday June 29, 2016 2:00pm - 3:15pm EDT
111AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 12: Pharm Quality, Session

4:00pm EDT

#363: Expedited Reviews and Other Pathways to Speed Up Access to Medicines
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-550-L01-P; CME 1.25; IACET 1.25; RN 1.25

Patients with unmet medical needs want early access to medicines. Regulators need to feel confident that the the benefit-risk balance of a medicine they are licensing is positive. Regulators from the EU, Japan, and the US will discuss how access to medicines can be speeded up and the use of postmarketing data to reduce the uncertainties.

Learning Objectives

Recognize the concepts and current progress with speeding up access to medicines in different regions.

Chair

Stella C.F. Blackburn

Speaker

Sooner or Later? Cost and Benefit of Utilizing Rolling Reviews in US and Japan
Toshiyoshi Tominaga

EU Adaptive Pathways Process
Hans-Georg Eichler

Expedited Reviews and Using Postmarketing Data to Supplement Clinical Trials
Gerald J. Dal Pan, MD



Chair
avatar for Stella Blackburn

Stella Blackburn

Vice President, Global Head of Early Access & Risk Management, RWI, QuintilesIMS
Dr Stella Blackburn is currently VP, Global Head of Early Access & Risk Management at QuintilesIMS. She joined QI in April 2014 after more than 25 years working in PhV and pharmacoepi in industry and the European Medicines Agency. Stella is a Fellow of the International Society of... Read More →

Speakers
avatar for Hans-Georg Eichler

Hans-Georg Eichler

Senior Medical Officer, European Medicines Agency, European Union
Dr. Eichler is responsible for coordinating activities between the European Medicine Agency's (EMA) scientific committees and giving advice on scientific and public health issues. Prior to joining EMA, Dr. Eichler was professor and chair of clinical pharmacology and vice-rector at... Read More →
avatar for Gerald Dal Pan

Gerald Dal Pan

Director, Office of Surveillance and Epidemiology, CDER, FDA, United States
Gerald J. Dal Pan, MD, MHS, is Director of the Office of Surveillance & Epidemiology in FDA’s Center for Drug Evaluation and Research, where he oversees adverse event surveillance and analysis, pharmacoepidemiology, risk management, and medication error prevention. A member of the... Read More →
avatar for Toshiyoshi Tominaga

Toshiyoshi Tominaga

Associate Executive Director (for International Programs), Pharmaceuticals and Medical Devices Agency (PMDA)
Dr. Tominaga is Associate Executive Director for International Programs. He supervises the overall strategy and conduct of international operations by PMDA. He joined MHLW after acquired PhD from Faculty of Pharmaceutical Sciences, the University of Tokyo. As a career official, he... Read More →


Wednesday June 29, 2016 4:00pm - 5:15pm EDT
201B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 08: Reg Affairs, Session
 
Thursday, June 30
 

9:00am EDT

#401: EMA/FDA Question Time
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: ACPE 1.50 Knowledge UAN: 0286-0000-16-611-L04-P; CME 1.50; IACET 1.50; RN 1.50

This forum will provide an opportunity for EMA and FDA leadership to explore at a roundtable discussion areas covered by the EMA/FDA confidentiality arrangements and discuss how both agencies contribute to global development and supervision of medicines. Experts from both Agencies who are at the forefront of EMA/FDA collaboration will explore topics such as innovation support to industry, use of real world data, patient involvement in the development, evaluation and post-authorization of medicines, and mutual reliance on GMP inspections.

The audience will be invited to submit questions of general interest. Please come prepared with your questions for the EMA/ FDA Question Time panel. You may submit questions and topics of interest in advance to annualmeetingprogram@DIAglobal.org, and include “EMA/FDA Question Time” in the subject line.

Learning Objectives

Summarize key issues discussed by EMA and FDA; Identify regulatory hot topics; Discuss the areas covered under the bilateral cooperation between EMA and FDA aimed at bringing new medicines to patients throughout the world while assuring consistent standards of quality, efficacy, and safety; Identify how to engage both agencies in the development of a medicine at the same time.

Chair

Sabine Haubenreisser
Sandra L. Kweder, MD, FACP

Speaker

Panelist
Emer Cooke, MBA

Panelist
Dara Corrigan, JD

Panelist
John K. Jenkins, MD

Panelist
Jordi Llinares Garcia

Panelist
Anabela Marcal, PharmD

Panelist
Heidi C. Marchand, PharmD

Panelist
Peter W. Marks

Panelist
Isabelle Moulon, MD



Chair
avatar for Sabine Haubenreisser

Sabine Haubenreisser

Liaison to the US FDA, European Medicines Agency, European Union
Sabine Haubenreisser, MSc, Ph.D., is a pharmacologist who joined the European Medicines Agency in 1997, where she held a variety of positions including scientific team leader and officer for external communications. In 2012 she was appointed EMA Liaison Official at the U.S. FDA in... Read More →
avatar for Sandra Kweder

Sandra Kweder

Deputy Director, Europe Office, Office of Global Programs and Strategies, FDA, FDA, United States
Sandra L. Kweder, MD, is Deputy Director of the Europe Office in the FDA. She is posted in Amsterdam, working alongside colleagues in the European Medicines Agency (EMA) to oversee a large portfolio of regulatory science working partnerships and collaborations that include experts... Read More →

Speakers
avatar for Emer Cooke

Emer Cooke

Chair, ICMRA; Executive Director, European Medicines Agency (EMA), Netherlands
Es Cooke was nominated as Executive Director with a renewable five-year mandate by the Agency’s Management Board on 25 June 2020 and is the first woman at the helm of EMA. "I take up the role of Executive Director of EMA amid a public health crisis of unprecedented scale,” said... Read More →
avatar for Dara Corrigan

Dara Corrigan

Acting Deputy Commissioner for Global Regulatory Operations and Policy, FDA
Leads a 5,000-member workforce devoted to FDA’s domestic and international product quality and safety efforts, including global data-sharing, development and harmonization of standards, field operations, compliance, and enforcement activities. She joined FDA in 2010, serving as... Read More →
avatar for Jordi Llinares Garcia

Jordi Llinares Garcia

Head of Product Development Scientific Support Department, European Medicines Agency, European Union
Jordi Llinares is a medical doctor specialised in clinical pharmacology. He worked as clinical pharmacologist at Hospital de Sant Pau and has experience as member of an ethics committee. Jordi has academic experience as lecturer in clinical pharmacology. He has a Masters degree in... Read More →
avatar for John Jenkins

John Jenkins

Director, Office of New Drugs, CDER, FDA
Dr. Jenkins is Board Certified in Internal Medicine and Pulmonary Diseases by the American Board of Internal Medicine. He joined FDA in 1992 and has been Director of the Office of New Drugs since 2002.
avatar for Anabela Marcal

Anabela Marcal

EMA Liaison Official to FDA, European Medicines Agency, Netherlands
Anabela holds a degree in pharmacy and a professional certification in hospital pharmacy. Anabela had joined the EMA in 1999. During her career at the Agency she held a number of roles in various areas and she is currently Head of Committees and Inspections Department.
avatar for Heidi Marchand

Heidi Marchand

Assistant Commissioner, Office of Health and Constituent Affairs, OC, FDA
Heidi Christl Marchand, Pharm.D. is currently the Assistant Commissioner for Health and Constituent Affairs at FDA. She has held leadership positions in global regulatory affairs with Novartis, Pfizer and Amgen. Dr. Marchand leads FDA’s office responsible for engaging external stakeholders... Read More →
avatar for Peter Marks

Peter Marks

Director, Center for Biologics Evaluation and Research, FDA, United States
Peter Marks received his graduate degree in cell and molecular biology and his medical degree at New York University and completed Internal Medicine residency and Hematology/Medical Oncology training at Brigham and Women’s Hospital in Boston. He has worked in academic settings teaching... Read More →
avatar for Isabelle Moulon

Isabelle Moulon

Head of Patients and Healthcare Professionals Department, European Medicines Agency, European Union
Qualified medical doctor from the University of Grenoble, specialising in endocrinology and metabolic diseases. She joined the European Medicines Agency in 1995. Since 2004, she has been developing the interaction with patients and healthcare professionals and was appointed Head of... Read More →


Thursday June 30, 2016 9:00am - 10:30am EDT
114 Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 19: DIAmond, Forum

10:45am EDT

#409: Current Status of Genetic Testing in Medical Therapies: What Regulations We May Need in a Convergent Regulatory Environment
Limited Capacity seats available

Component Type: Session
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-560-L04-P; CME 1.25; IACET 1.25; RN 1.25

In the current status of new treatment, prevention and diagnostic modalities, genetic testing in medical therapies offers promising potential, and public interest is extremely high. What regulations do we need in a convergent regulatory environment?

Learning Objectives

Recognize the huge impact of genetic testing in health care; Identify challenges and opportunities that exist in the current regulatory environment; Realize that many questions about patient rights and privacy still need to be resolved; Conceive the legal framework and the impact it has in today's health care environment.

Chair

Joseph C. Scheeren, PharmD

Speaker

Patient Perspective
Sue Friedman, DVM

Industry Perspective
Morten Sogaard, PhD

Regulator Perspective
Robert Schuck, PharmD, PhD



Chair
avatar for Joseph Scheeren

Joseph Scheeren

Senior Vice President, Head Regulatory Affairs, Pharma and Consumer Health, Bayer
Joseph Scheeren, Pharm.D. is Senior Vice President, Global Head of Regulatory Affairs Pharma & Consumer Health at Bayer. He has 30+ yrs exp. as Global Regulatory Affairs professional (France, Germany, Switzerland, US & China). He is an active member of the DIA Board of Directors... Read More →

Speakers
SF

Sue Friedman

Executive Director and Founder, Facing Our Risk of Cancer Empowered (FORCE)
Dr. Friedman was a practicing veterinarian in 1996 when she was diagnosed at age 33 with breast cancer and later learned she carried a BRCA2 mutation. She founded the nonprofit organization Facing Our Risk of Cancer Empowered (FORCE) in 1999 to improve the lives of people affected... Read More →
avatar for Robert Schuck

Robert Schuck

Clinical Pharmacologist, Genomics and Targeted Therapy, OTS, CDER, FDA
Robert Schuck, Pharm.D., Ph.D. is a Clinical Pharmacologist in the Genomics and Targeted Therapy Group at the FDA. In his current position, Dr. Schuck contributes to regulatory review of investigational new drug (IND), new drug (NDA), and biologic licensing (BLA) applications to effectively... Read More →
MS

Morten Sogaard

Vice President and Head, Enterprise Scientific Technology Operations, Pfizer Inc
Morten has been with Pfizer since 2009 and is VP, Enterprise-wide Scientific Technology Operations and a member of Pfizer’s R&D leadership team . He oversees technology investment and Pfizer’s human genetics, computational biomedicine, diagnostics and bio-banking organizations... Read More →


Thursday June 30, 2016 10:45am - 12:00pm EDT
113C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 09: Med Devices-InVitro-CombProd, Session