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Monday, June 27
 

8:30am EDT

#117: IDMP: A Compliance Project or a New Way of Conducting Business?
Limited Capacity seats available

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

This session will present different solution scenarios on how to approach the identification of medicinal products (IDMP) based on two very different starting points and discuss the mapping of the mandatory ISO IDMP data fields to the risk management plan (RMP), the EU integrated format, and explore the challenges of document life cycle management impacted by this new worldwide standard.

Learning Objectives

Discuss how you could approach the identification of medicinal products (IDMP) from the angle of integration and convergence to ensure that your IDMP project will become the first stepping stone on a journey towards an integrated company, tying strings to the regulations, clinical trial regulation, ISO ICSR etc; Discuss potential benefits you can alleviate from IDMP; Describe the mapping of mandatory ISO IDMP data fields and controlled vocabularies that directly impact the risk management plan.

Chair

Niels Gronning, MSc

Speaker

ISO IDMP Impact Assessment on the Risk Management Plan
Debbie Persaud, MSc

IDMP: A Compliance Project
Bernie Coney, MA



Chair
avatar for Niels Gronning

Niels Gronning

Principal Consultant, NNIT A/S
With a professional and academic bacground within the pharmaceutical industry Niels Grønning possesses extensive knowledge within the area of IT & Life Sciences. His area of expertise is predominantly found within regulatory affairs, IT (strategy, architecture & compliance) and more... Read More →

Speakers
avatar for Debbie Persaud

Debbie Persaud

Regulatory Affairs SME, NNIT Inc.
Debbie Persaud is a RA SME at NNIT US. Prior to joining NNIT, she worked as a RA Manager at Pfizer and Ethicon specializing in global regulatory submission strategies for biologics and medical devices. She has a MSc. in Biomedical Sciences from the University of Medicine and Dentistry... Read More →


Monday June 27, 2016 8:30am - 9:30am EDT
109AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 14: Clin Safety-PV, Session

8:30am EDT

#116: Has the EU Good Pharmacovigilance Practices Delivered on Its Intended Promise and Commitment?
Limited Capacity seats available

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

The session will review the implementation status of the 2010 EU Pharmacovigilance Legislation and its associated Good Pharmacovigilance Practices Guidelines, focusing on the key challenges and uncertainties arising from implementation, as well as some future proposals to measure impact on facilitating the performance of pharmacovigilance in the European Union. Did it do what it originally set out to achieve? Key to the success of implementing a robust pharmacovigilance system is the ability to strengthen the monitoring of benefit risk throughout a products life cycle. The results of the PROTECT work stream that arose as a quantum leap forward in benefit risk evaluation from the Innovative Medicines Initiative in the EU will be explored and how the results have changed industry and regulatory authority standards.

Learning Objectives

Discuss the current status, challenges, and uncertainties arising from the implementation of the EU Good Pharmacovigilance Practices Guidelines associated with the 2010 EU Pharmacovigilance Legislation; Describe future strategies to measure the impact that the legislation and guidelines have had since implementation; Explore how the results of PROTECT have changed industry and regulatory standards.

Chair

Valerie E. Simmons, MD, FFPM

Speaker

Introduction, General Overview of Implementation of the EU GVP Guidelines: Did They Actually Deliver?
Valerie E. Simmons, MD, FFPM

IMI PROTECT: Challenges, Successes, and the Effect on PhV in Europe
Stella C.F. Blackburn

Important Risks Resulting from EU PV Legislation and Guidance: Best Practice to Allow Optimized Patient Safety?
Leonardo Ebeling



Chair
avatar for Valerie Simmons

Valerie Simmons

EU QPPV, Global Patient Safety, Eli Lilly and Company Ltd
Dr. Simmons is currently the EU QPPV for Eli Lilly & Company Ltd. She is a registered physician from the University of London and, since joining the pharmaceutical industry in 1987, she has focussed her career drug safety through senior management positions in Glaxo Eli Lilly. Val... Read More →

Speakers
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 →
LE

Leonardo Ebeling

General Manager, Dr. Ebeling & Assoc. GmbH
Dr. Leonardo Ebeling, general manager and co-founder of Dr. Ebeling & Assoc., located in Hamburg, Germany. He studied medicine at the universities of Marburg and Hamburg. After completing his studies in 1984, he worked for big and medium-sized pharmaceutical companies in leading positions... Read More →


Monday June 27, 2016 8:30am - 9:45am EDT
103C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 14: Clin Safety-PV, 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

#136: Clinical Data Disclosure and Transparency: ClinicalTrials.gov Final Rule, EU Requirements, and Other Key Updates
Limited Capacity seats available

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

This forum will involve a panel and analyze the ClinicalTrials.gov Final Rule, discuss how companies are navigating the US and EU disclosure/transparency mandates, and discuss data sharing expectations.

Learning Objectives

Identify the requirements of the Final Rule expanding the ClinicalTrials.gov database; Describe how industry is navigating US and EU disclosure mandates; Discuss how companies are approaching data sharing expectations

Chair

Robert Paarlberg, MS

Speaker

Panelist
Rebecca J. Williams

Panelist
Marla Jo Brickman, PhD



Chair
avatar for Robert Paarlberg

Robert Paarlberg

Principal, Paarlberg & Associates LLC, United States
Robert Paarlberg is Principal of Paarlberg & Associates LLC, a consultancy specializing in regulatory policy, regulatory intelligence and global clinical trial disclosure strategy and operations. Prior to founding Paarlberg & Associates LLC, Bob worked at Pharmacia (Upjohn) and UCB... Read More →

Speakers
avatar for Marla Jo Brickman

Marla Jo Brickman

Senior Director/Team Leader, Clinical Trial Disclosure Group, Pfizer Inc
Marla Jo Brickman, PhD, is the Senior Director/Team Leader for the Clinical Trial Disclosure Group at Pfizer and serves as the global disclosure policy lead for all clinical trial registration and results disclosures, as well as, providing oversight of Pfizer’s implementation of... Read More →
avatar for Rebecca Williams

Rebecca Williams

Acting Director, ClinicalTrials.gov, NCBI, National Library of Medicine, NIH
Rebecca Williams, PharmD, MPH, is Acting Director, ClinicalTrials.gov at the National Library of Medicine, National Institutes of Health. She moved into this role after serving as the Assistant Director for over a decade. She is responsible for technical, scientific, policy, regulatory... Read More →


Monday June 27, 2016 10:45am - 12:00pm EDT
202AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 10: Pub Pol/HealthCare Compl/Law, Forum
 
Tuesday, June 28
 

8:00am EDT

#201: International Regulatory Convergence, Collaboration, and Cooperation
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: CME 1.75; IACET 1.75; RN 1.75

Join senior leadership from international regulatory authorities to hear the latest on multi- and bilateral initiatives that avoid duplication and increase mutual reliance, their strategic governance, and their impact on industry.

Part 1 of this session will see the heads of three regulatory agencies provide updates on the challenges facing them as global regulators, both domestic and within the framework of international cooperative initiatives.

In Part 2, the panel will be joined by additional heads of regulatory authorities with leading roles in the International Coalition of Medicines Regulatory Authorities (ICMRA) and will provide an overview of the developing role of ICMRA and initiatives aimed at facilitating interactions, coordination, and convergence. It will also address ICMRA's current status of strategic collaboration in areas such as pharmacovigilance, crisis management and supply chain integrity (GMP and traceability).

The combined panel will look at existing initiatives to avoid duplication and increase mutual reliance between regulators, the need for strategic governance of these initiatives and their impact on industry and other stakeholder.

Learning Objectives

Identify the current framework of bilateral and multilateral international cooperation initiatives; Describe how international regulatory authorities cooperate and collaborate, and the public health, economic, and political drivers for that cooperation; Describe how international regulatory agencies seek to set the strategic direction and priorities for the various regulatory initiatives.

Chair

Emer Cooke, MBA

Speaker

Panelist
Emer Cooke, MBA

Panelist
Robert M. Califf, MD

Panelist
Tatsuya Kondo, MD, PhD

Panelist
Anil Arora

Panelist
Lorraine Nolan, PhD

Panelist
Jonathan Mogford

Panelist
John Skerritt, PhD

Panelist
Jarbas Barbosa, MD, PhD



Chair
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 →

Speakers
avatar for Anil Arora

Anil Arora

Chair of the ICMRA; Assistant Deputy Minister, Health Products and Food Branch, Health Canada
Mr. Arora has a breadth of experience in the private and public sectors. He has worked internationally-bilaterally, as well as with the UN and the OECD, including leading a multi-year program with the National Bureau of Statistics in the modernization of China’s statistical system... Read More →
avatar for Jarbas Barbosa

Jarbas Barbosa

Director- President, Agência Nacional De Vigilância Sanitária (ANVISA)
Jarbas Barbosa da Silva Jr. is a public health physician and epidemiologist, with national and international experience in public health, epidemiology applied to health services, health surveillance, prevention and control of diseases and illnesses, and management of health systems... Read More →
avatar for Robert Califf

Robert Califf

Commissioner, FDA
Robert M. Califf, MD, MACC, is the Food and Drug Administration's commissioner of food and drugs. As the top official of the FDA, Dr. Califf is committed to strengthening programs and policies that enable the agency to carry out its mission to protect and promote the public healt... Read More →
avatar for Tatsuya Kondo

Tatsuya Kondo

Chief Executive, Pharmaceuticals and Medical Devices Agency (PMDA)
Dr. Tatsuya Kondo is Chief Executive of PMDA since 2008. He spent most of his career as a neurosurgeon after his graduation from the University of Tokyo in 1968. He has various experiences including a hospital doctor, a fellowship in Max-Planck Institute for brain tumor research... Read More →
avatar for Jonathan Mogford

Jonathan Mogford

Director of Policy, Medicines and Healthcare products Regulatory Agency (MHRA),
avatar for Lorraine Nolan

Lorraine Nolan

Chief Executive, Health Products Regulatory Authority (HPRA)
Ms Nolan joined the HPRA in 2001 and since that time has held a number of different roles at senior level within the organisation across a range of areas including inspection and authorisation of human medicines, medical devices, cosmetics and controlled substances. Prior to assuming... Read More →
avatar for John Skerritt

John Skerritt

Deputy Secretary for Health Products Regulation, Commonwealth Department of Health, Australia
Dr John Skerritt joined the Australian Department of Health in 2012 and is currently a Deputy Secretary and member of the executive team of the Department of Health. He was formerly the National Manager of the Therapeutic Goods Administration (TGA), until his role was expanded and... Read More →


Tuesday June 28, 2016 8:00am - 9:45am EDT
114 Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 19: DIAmond, Forum

4:00pm EDT

#273: Improving Adverse Drug Reaction Information in Product Labels
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-587-L04-P; CME 1.25; IACET 1.25; RN 1.25

Adverse drug reactions (ADRs) are an important part of a product label. In this session, we will recommend ways to make ADR information in product labels more understandable and better reflective of the risk of a drug relative to a comparator. We will also discuss the importance of end-to-end labeling and tracking to ensure pharmacovigilance compliance.

Learning Objectives

Discuss how adverse drug reactions (ADRs) are presented in EU and US drug labels; Explain why the qualitative categories of ADR in an EU label and the pooling strategy to obtain ADR frequencies in a US label are inadequate; Describe improved approaches to summarize and present different types of adverse events; Describe key building blocks for a compliant end-to-end labeling system.

Chair

Brenda Crowe, PhD

Speaker

Rational Presentation of Adverse Reactions in Drug Labeling
Ellis Unger, MD

A New Paradigm in Patient Safety: The Importance of End-to-End Labeling and Tracking in Ensuring Pharmacovigilance Compliance
Oliver Steck, MBA

Augmenting Product Labels with Real-World Evidence: Lessons from OHDSI
Patrick Ryan



Chair
avatar for Brenda Crowe

Brenda Crowe

Senior Research Advisor, Global Statistical Sciences, Eli Lilly and Company
Brenda Crowe is a Senior Research Advisor at Eli Lilly and Company (Lilly) where she leads a Safety Analytics team. She obtained a PhD in Statistics from the University of Toronto in 1997 and has 20 years of pharmaceutical industry experience.

Speakers
PR

Patrick Ryan

Head, Epidemiology Analytics, Janssen Pharmaceuticals, Inc.
Patrick Ryan, PhD is Senior Director of Epidemiology and the Head of Epidemiology Analytics at Janssen Research and Development. He is currently a collaborator in Observational Health Data Sciences and Informatics (OHDSI, htttp://ohdsi.org). He served as a principal investigator of... Read More →
avatar for Oliver Steck

Oliver Steck

Principal, Navitas Inc.
He has been a business consultant for more than 14 years. Since joining WCI, he has helped global pharmaceutical clients to optimize their processes in regards of content management, different compliance related issues, risk management and Pharmacovigilance.
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 4:00pm - 5:15pm EDT
109AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 15: Statistics, Session
 
Wednesday, June 29
 

2:00pm EDT

#339: Evolution of Patient Safety Reporting: PSURs to RMPs, Challenges, and How to Face Them
Limited Capacity seats available

Component Type: Symposium
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-532-L05-P; CME 1.25; IACET 1.25; RN 1.25

The EU pharmacovigilance (PV) legislation has introduced significant changes to the presentation of clinical trial and postmarketing information. Data relevant to the benefit-risk balance of a product must be assessed against the existing standard of care, all of which evolve over time. Documents such as the risk management plan have become increasingly complex and writing them requires strong project management and regulatory skills. This session will describe the experience of managing PV documents and regulatory feedback in this new era, explain why writing for a lay audience is challenging and why it is an important challenge for the pharmaceutical industry to embrace, and will illustrate the challenges of producing, managing, and dealing with evolving benefit-risk assessments with some concrete examples.

Learning Objectives

Describe how to manage the writing of EU-Risk Management Plans including possible challenges and hands-on solutions; Identify the importance of writing for the lay audience along with suggested approaches; Discuss synergies within the preparation of periodic safety documents including how to effectively use them with respect to continuous benefit-risk evaluation.

Chair

Sven Schirp

Speaker

Periodic Reporting in Drug Safety: From Safety Updates to Continuous Benefit-Risk Evaluations
Leonardo Ebeling

The EU-Risk Management Plan from a Medical Writer’s Perspective
Sven Schirp

Writing the Lay Summary (Section VI) of Risk Management Plans: Why and How?
Lisa Chamberlain James, PhD



Chair
SS

Sven Schirp

Head of Global Pharmacovigilance Writing, Boehringer Ingelheim Pharma GmbH & Co. KG
Sven Schirp started his medical writing career in 1997. To date, he has covered a wide range of medical writing services, from biomedical publications and pharmacovigilance documents to global marketing applications. He is currently Head of Global Pharmacovilgilance Writing at Boehringer... Read More →

Speakers
LE

Leonardo Ebeling

General Manager, Dr. Ebeling & Assoc. GmbH
Dr. Leonardo Ebeling, general manager and co-founder of Dr. Ebeling & Assoc., located in Hamburg, Germany. He studied medicine at the universities of Marburg and Hamburg. After completing his studies in 1984, he worked for big and medium-sized pharmaceutical companies in leading positions... Read More →
avatar for Lisa Chamberlain James

Lisa Chamberlain James

Senior Partner, Trilogy Writing & Consulting Ltd.
After her PhD, Lisa started her writing career in the pharmaceutical industry in 2000. At Trilogy, in addition to company management, she writes a wide array of clinical documents and has a special interest in drug safety and patient information. Lisa is an experienced trainer, running... Read More →


Wednesday June 29, 2016 2:00pm - 3:15pm EDT
203AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 06: Med Comm-Wrtg-MSL, Symposium

4:00pm EDT

#372: Impact of the European Medicines Agency’s Medical Literature Monitoring Service on Pharmacovigilance Processes
Limited Capacity seats available

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

On July 1, 2015, the European Medicines Agency initiated the monitoring of medical literature for reports of suspected adverse reactions to medicinal products containing certain active substances and entering the relevant information into the EudraVigilance database. One of the key objectives of this initiative is to prevent duplication of cases reported by multiple marketing authorization holders (MAHs) for the same active substance through worldwide literature searches. Other intended benefits are to enhance the efficiency of adverse reactions reporting, improve data quality, contribute to resource savings, simplify processes, and support signal detection activities. This session will discuss the need for MAHs to assess the impact of this initiative on their existing process of literature safety report identification, case processing, and expedited reporting.

Learning Objectives

Identify the salient features of the European Medicine Agency's (EMA) medical literature monitoring (MLM) service; Assess the impact on existing global literature search, case processing, and expedited reporting; Identify measures required to align existing pharmacovigilance processes consequent to the implementation of EMA’s MLM service.

Chair

Vineet Kacker, PhD

Speaker

EMA Medical Literature Monitoring Service: Impact on EU Pharmacovigilance
Vineet Kacker, PhD

Authority-Based Medical Literature Monitoring in the EU: Impact on US and Global Pharmacovigilance
Leonardo Ebeling



Chair
avatar for Vineet Kacker

Vineet Kacker

Managing Director and Co-founder, APCER Life Sciences
Dr. Vineet Kacker is a Pharmacologist having completed his PH.D in 1997 from All India Institute of Medical Sciences in India. After more than 15 years in Academia, he switched his interests to Pharmaceutical Industry in 2000 and since then he has worked in Regulatory and Pharmacovigilance... Read More →

Speakers
LE

Leonardo Ebeling

General Manager, Dr. Ebeling & Assoc. GmbH
Dr. Leonardo Ebeling, general manager and co-founder of Dr. Ebeling & Assoc., located in Hamburg, Germany. He studied medicine at the universities of Marburg and Hamburg. After completing his studies in 1984, he worked for big and medium-sized pharmaceutical companies in leading positions... Read More →


Wednesday June 29, 2016 4:00pm - 5:00pm EDT
113C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 14: Clin Safety-PV, Forum