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Trk 12: Pharm Quality [clear filter]
Monday, June 27
 

8:30am

#115: Clinically Relevant Specifications: Translating Voice of the Patient Into Quality Attributes of the Product
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-605-L04-P; CME 1.25; IACET 1.25; RN 1.25

Clinical relevance has re-emerged within recent discussions in both the quality and regulatory arenas, with specific focus on patient expectations, clinically relevant specifications, residual uncertainty, and benefit-risk based decision making. Translating highly technical information into the pertinent patient-centric frame requires an intricate balance. This session highlights multiple opportunities for collaboration and communication, with the end goal of improving medicines, ensuring their availability, and assuring their use in accordance with patient needs.

Learning Objectives

Share common experiences regarding the establishment of clinically relevant specifications; Identify areas for future discussion with regard to clinical relevance in the quality arena; Discuss specific cases that illustrate establishment and/or challenges establishing clinically relevant specifications.

Chair

Richard T. Lostritto

Speaker

Paving the Road Toward Setting Clinically Relevant Drug Product Specifications: The Relevance of Biopredictive Dissolution Testing
Sandra Suarez Sharp, PhD

Industry Perspective
Ganapathy Mohan, PhD

FDA Perspective
Laurie Graham



Chair
RL

Richard Lostritto

Acting Director, Office of Policy for Pharmaceutical Quality, OPQ, CDER, FDA
Richard (Rik) Lostritto currently serves as a Division Director In FDA's ONDQA. Prior to this, he served in the FDA as a Team Leader, and Chemsitry Reviewer.

Speakers
LG

Laurie Graham

Acting Director, DIPAP, OPPQ, OPQ, CDER, FDA
Ms. Graham is the Acting Directorof the Division of Internal Policies and Programs (DIPAP), which leads the development and evaluation of OPQ internal policy documents.
avatar for Ganapathy Mohan

Ganapathy Mohan

Head of External Affairs (Quality), Merck & Co., Inc.
Ganapathy Mohan leads the Global External Advocacy and strategies for Global Quality and Compliance. Prior to this until April 2017, he was the head of Small Molecule Development Quality. Mohan was the head of Global CMC regulatory Affairs at Merck until April 2015. Prior to joining... Read More →
SS

Sandra Suarez Sharp

Biopharmaceutics Lead (Acting), DB Branch III, ODNP, OPQ, CDER, FDA
Dr. Sandra Suarez-Sharp joined the Office of Clinical Pharmacology (OCP) at the FDA, in September 1999. Currently, she works at the Office of New Drug Products/Division of Biopharmaceutics (FDA/OPQ/ONDP) as a Master Biopharmaceutics Reviewer/Biopharmaceutics Lead (acting) supporting... Read More →


Monday June 27, 2016 8:30am - 9:45am
111AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

10:45am

#138: Risk Communication and Management: The Art of Communicating Risk - Challenges and Best Practices
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-599-L04-P; CME 1.25; IACET 1.25; RN 1.25

The adoption of quality by design principles and subsequent incorporation of enhanced approaches in regulatory submissions introduced several challenges for industry as well as regulators. This session will discuss how the principles described in ICH Q9 are applied, specifically how quality risks are assessed, managed, and communicated by industry and evaluated by regulators and how results from risk assessments are used to determine quality criteria for demonstrating control and developing and maintaining a robust control strategy for a product.

Learning Objectives

Describe how quality risks are assessed, managed, and communicated by industry; Discuss how quality risks are evaluated by regulators.

Chair

Kristin Murray, MS

Speaker

Benefit-Risk Considerations and Strategies for Investigation and Control of Impurities
David White

Risk Management: A Team Sport
Wendy Wilson-Lee, BSN, PhD

Applications of Risk Management Tools to Quality by Design and Control Strategy Creation in Rare Disease
Joseph Kauten



Chair
KM

Kristin Murray

Director, Global CMC Regulatory Affairs, Shire Pharmaceuticals
Kristin Murray, MS, BS - Ms. Murray is a director in the Global Regulatory Affairs CMC department and oversees a team who manage global regulatory CMC submissions for both investigational and commercial products at Shire Pharmaceuticals, Lexington, MA. Before her tenure in regulatory... Read More →

Speakers
JK

Joseph Kauten

Biologics CMC Control Strategy Leader, Shire Pharmaceuticals
Dynamic Technical Leader with a proven track record of value driven innovation, robust process development, and cross-functional influence. Extensive experience in facility and process design from greenfield/brownfield through to successful technology/process transfer, process performance... Read More →
avatar for David White

David White

Principal Scientist, AstraZeneca
I joined pharmaceutical development in 2003 as line manager in analytical science working primarily in late phase projects. After secondments to formulated product development and then post approval regulatory, I returned to drug substance in 2014 as a principle scientist responsible... Read More →
avatar for Wendy Wilson-Lee

Wendy Wilson-Lee

Acting Branch Chief, Office of New Drug Products, OPQ, CDER, FDA
Wendy is an acting Branch Chief in the Office of New Drug Products, bringing 10 years of review experience to the position. She has a B.S. in Chemical Engineering as well as a B.S. in Chemistry from North Carolina A&T State University. She earned her Ph.D. in Pharmaceutical Science... Read More →


Monday June 27, 2016 10:45am - 12:00pm
109AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
 
Tuesday, June 28
 

10:30am

#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, Global CMC, Pfizer Inc
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 PhRMA, ICH, 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
112AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

2:00pm

#245: Risk-Based Inspections
Limited Capacity seats available

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

Inspections are a critical component for assuring product quality. The adoption of a risk-based approach to inspections has enabled the integration of product review with traditional inspection criteria and focuses efforts on inspection issues rather than simply on assurance of compliance. This session will highlight ongoing efforts and initiatives geared towards the continuing implementation of risk-based inspections.

Learning Objectives

Discuss related procedural and/or policy challenges and present specific case studies related to risk-based inspections; Identify best practices and ideas for future discussion with regard to risk-based inspections; Identify potential areas for further collaboration on risk-based inspections.

Chair

Mahesh R. Ramanadham, PharmD, MBA

Speaker

Quality Agreements: Defining the Business of Pharmaceutical Quality
Karen Bossert

Integrated Quality Assessment of the Manufacturing Process and Facilities
Robert Iser, MS



Chair
avatar for Mahesh Ramanadham

Mahesh Ramanadham

Division Director (Acting), Div. of Inspectional Assessment, OPF, OPQ, CDER, FDA
Acting Director for the Division of Inspection Assessment within OPQ/OPF. His division is primarily responsible for the center level discipline review of facilities and inspections in support of drug applications. He joined the Agency in November 2009 after graduating with his PharmD... Read More →

Speakers
KB

Karen Bossert

Vice President, Scientific Affairs, Lyophilization Technology, Inc.
Karen Bossert is the Vice-President, Scientific Affairs at Lyophilization Technology, Inc. She has over 25 years of experience in pharmaceutical manufacturing and development. She received her Bachelor of Science degree in Pharmacy and her Doctorate in Pharmaceutics. Karen has authored... Read More →
avatar for Robert Iser

Robert Iser

Acting Director, Office of Process and Facilities, OPQ, CDER, FDA
Bob joined the FDA in 2003. He is currently the acting Director of the Office of Process & Facilities. Prior to the formation of OPQ, Bob was acting Associate Director for Policy Development in OPS. He was also a Division Director and CMC Team Leader in OGD. Prior to joining the FDA... Read More →


Tuesday June 28, 2016 2:00pm - 3:15pm
111AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

4:00pm

#270: Implementing Knowledge Management: Industry Perspectives
Limited Capacity seats available

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

This session will discuss how knowledge management is a pivotal systematic element of life cycle management. The use of prior knowledge in risk assessments in the design, development, and maintenance of product quality as well as the justification for changes is predicated on robust knowledge management systems that integrate information and data from multiple sources.

Learning Objectives

Discuss the role knowledge management plays in the design, development, and maintenance of product quality.

Chair

Paige Kane

Speaker

Think Big but Start Small: The Evolution of Knowledge Management at a Large Pharmaceutical Company
Jodi Schuttig, MBA

CMC Data Readiness and Future Proofing for IDMP
Kim S. Northam

Why Wonder When You Can Know?
James Roberts, PhD



Chair
avatar for Paige Kane

Paige Kane

Regulatory Science Researcher/ Director KM CoE, Dublin Institute of Technology/ Merck & Co., Inc.
Paige Kane, CPIP, is the Director of Knowledge Management Pfizer Global Supply/ Global Technology Services. Ms. Kane is responsible for developing and implementing the Knowledge Management Strategy for Pfizer Global Supply (PGS) with a strong focus on people, processes and collaboration... Read More →

Speakers
avatar for Kim Northam

Kim Northam

Manager, Regulatory Affairs, Accenture Accelerated R&D Services
Kim has ten years’ experience in CMC and has managed various projects from complex in licencing activities, to compliance and remediation, and also process transformations. Through her tenure at Accenture Kim has helped companies improve their CMC data management ensuring timely... Read More →
avatar for James Roberts

James Roberts

Head, Platform Analysis, GlaxoSmithKline
James Roberts leads a team of scientists, engineers and compliance experts to embed data integrity, data quality and compliance into analytical testing processes in real-time. He founded Allotrope Foundation in 2012 with colleagues from other pharma companies and is using the Allotrope... Read More →
avatar for Jodi Schuttig

Jodi Schuttig

Director, Knowledge Management, Merck & Co., Inc.
Jodi Schuttig, Director of Knowledge Management in the Merck Manufacturing Division, has over 25 years of experience in the phar¬maceutical sector through various roles at Merck. Jodi holds a B.S. in Mechanic Engineering and a M.B.A. in Business Administration. In 2013 Jodi joined... Read More →


Tuesday June 28, 2016 4:00pm - 5:15pm
111AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
 
Wednesday, June 29
 

10:30am

#321: Office of Pharmaceutical Quality Update
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-606-L04-P; CME 1.25; IACET 1.25; RN 1.25

The formation of the Office of Pharmaceutical Quality (OPQ) is a milestone in FDA efforts to assure the quality and availability of medicines to the public. OPQ's motto of "One Quality Voice" is manifested in the organizational construct that provides functional expertise but enables a team approach to regulatory review and inspection. This session will outline current status and ongoing initiatives underway in OPQ and will provide the audience with access to selected OPQ senior leadership.

Learning Objectives

Discuss current updates on initiatives and implementation strategies for the Office of Pharmaceutical Quality (OPQ); Identify additional information regarding forthcoming activities in OPQ.

Chair

Robert Iser, MS

Speaker

Panelist
Michael Kopcha

Panelist
Lawrence X. Yu, PhD



Chair
avatar for Robert Iser

Robert Iser

Acting Director, Office of Process and Facilities, OPQ, CDER, FDA
Bob joined the FDA in 2003. He is currently the acting Director of the Office of Process & Facilities. Prior to the formation of OPQ, Bob was acting Associate Director for Policy Development in OPS. He was also a Division Director and CMC Team Leader in OGD. Prior to joining the FDA... Read More →

Speakers
avatar for Michael Kopcha

Michael Kopcha

Director, Office of Pharmaceutical Quality, CDER, FDA
With more than 25 years of pharmaceutical industry experience, Dr. Kopcha’s areas of expertise include formulation and process development, process validation, technology transfer, off-shoring/outsourcing, and change management. Before joining FDA, Dr. Kopcha served as vice president... Read More →
avatar for Lawrence Yu

Lawrence Yu

Deputy Director, Office of Pharmaceutical Quality, CDER, FDA
Dr. Lawrence X. Yu is the Deputy Director for Science and Director of Chemistry at the Office of Generic Drugs, Food and Drug Administration, overseeing CMC review operation, policy development, and regulatory research with over 140 staff scientists. He is also adjunct Professor of... Read More →


Wednesday June 29, 2016 10:30am - 11:45am
113B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

2:00pm

#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
111AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

4:00pm

#369: Innovative and Emerging Technologies
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-607-L04-P; CME 1.25; IACET 1.25; RN 1.25

Recent technological advances in manufacturing, product delivery, and control provide opportunities and challenges to improve quality assurance. Improved regulatory understanding of continuous manufacturing, product delivery, and control should enable and encourage adoption of novel technologies. This session will focus on emerging innovative technology and approaches to developing quality products.

Learning Objectives

Discuss emerging innovative technology and how quality assurance can be improved.

Chair

Daniel Blackwood

Speaker

Process Validation for Lyophilized Drug Products: Developing a Program for Continued Process Verification
Karen Bossert

Portable, Continuous, Miniature, and Modular: An Integrated Development and Manufacturing System for Solid Oral Dossage Forms
Daniel Blackwood

API Particle Engineering: Bridging Primary and Secondary Processes for Continuous Oral Solid Dose Manufacturing
Sonja A. Sharpe, PhD



Chair
avatar for Daniel Blackwood

Daniel Blackwood

Director, Pharm Science Technology and Innovation, Pfizer Inc
Daniel O. Blackwood is a Director, Technology & Innovation, within PharmaTherapeutics Pharmaceutical Sciences at Pfizer. He received his BS in Mechanical Engineering from Cornell University in Ithaca NY, and his MS in Industrial Engineering from Columbia University in New York City... Read More →

Speakers
KB

Karen Bossert

Vice President, Scientific Affairs, Lyophilization Technology, Inc.
Karen Bossert is the Vice-President, Scientific Affairs at Lyophilization Technology, Inc. She has over 25 years of experience in pharmaceutical manufacturing and development. She received her Bachelor of Science degree in Pharmacy and her Doctorate in Pharmaceutics. Karen has authored... Read More →
avatar for Sonja Sharpe

Sonja Sharpe

Director, Technology Development, Advanced Manufacturing Technologies, GlaxoSmithKline
Sonja leads a global team responsible for developing novel secondary (drug product) manufacturing technologies with the goal of streamlining and simplifying drug product process development and manufacturing. She has over 11 years of experience in the area of process engineering and... Read More →


Wednesday June 29, 2016 4:00pm - 5:15pm
109AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA