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10: RegCMC-Product Quality [clear filter]
Monday, June 24
 

2:15pm

#151: Update on ICH Quality Topics
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-551-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will provide updates on ICH’s efforts to develop new and revised globally harmonized guidelines related to product quality and regulatory CMC topics. Topics include Lifecycle Management, Continuous Manufacturing, and Analytical Methods.

Learning Objectives

Identify the technical and regulatory issues under discussion in ICH as they related to regulatory CMC and product quality topics; Discuss various perspectives from the expanded ICH membership on the impact, opportunities and challenges for the new and ongoing ICH Quality Topics.

Chair

Olivia Shopshear, MS

Speaker

ICH Quality Vision and Context Setting
Camille Jackson

M9 and IQDG
Roger Nosal, PhD

Q2(R2) - Analytical Procedure Validation / Q14 - Analytical Procedure Development
Nasir Egal, PhD

Q12
Sarah Pope Miksinski, PhD

Q13
Ganapathy Mohan, PhD



Speakers
CJ

Camille Jackson

Associate Vice President, Science and Regulatory Advocacy, Pharmaceutical Research and Manufacturers of America (PhRMA)
Camille Jackson is currently Associate Vice President of Science and Regulatory Advocacy at PhRMA. In this role, she manages PhRMA’s international regulatory policy initiatives including engagement in the International Council for Harmonization (ICH) and the APEC Regulatory Harmonization... Read More →
avatar for Nasir Egal

Nasir Egal

Head of Global Quality External Affairs, Sanofi
Nasir EGAL currently leads the Sanofi Global Quality External Affairs strategy. Prior to this role, he held various positions of increasing responsibilities in Sanofi, Novartis & Merck. He has a broad international experience working across various cultures and geographies leading... Read More →
avatar for Sarah Pope Miksinski

Sarah Pope Miksinski

Senior Director, AstraZeneca
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 →
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 Olivia Shopshear

Olivia Shopshear

Senior Director, Science and Regulatory Advocacy, Pharmaceutical Research and Manufacturers of America (PhRMA)
Olivia is a senior director of Science and Regulatory Advocacy at the Pharmaceutical Research and Manufacturers of America (PhRMA). Olivia has extensive multi-disciplinary program management and policy experience in the biopharmaceutical and biodefense industries, ranging from pre-clinical... Read More →


Monday June 24, 2019 2:15pm - 3:15pm
Room 8 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

3:30pm

#168: Regulating Innovation in Chemistry, Manufacturing, and Controls: Challenges and Opportunities
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-569-L04-P; CME 1.00; IACET 1.00; RN 1.00

The pace of innovation in the pharmaceutical industry has accelerated tremendously. Future goals for efficiently regulating innovative modalities and technologies could be aided by more regulatory harmonization and industry efforts. This session will present an overview of the landscape for innovative modalities and emerging technologies in the field of human therapeutics, and the regulatory CMC challenges associated with their product development and approval.

Learning Objectives

Discuss the landscape for innovative modalities and emerging technologies in the field of human therapeutics; Describe the regulatory CMC challenges associated with their product development and approval.

Chair

Nina S. Cauchon, PhD, RAC

Speaker

Regulating Innovation in CMC – A Perspective from Industry
Nina S. Cauchon, PhD, RAC

Integrated Manufacturing and its Opportunities to Low Cost Vaccine Manufacture
J. Christopher Love, PhD, MA

Regulating Advanced Therapy: Gene and Cell Therapy Products
Raj K. Puri, MD, PhD



Speakers
avatar for Nina Cauchon

Nina Cauchon

Director Regulatory Affairs CMC, Amgen Inc.
Nina S. Cauchon, PhD, leads external engagement activities within RA-CMC. She has experience leading both early phase & commercial programs, including small molecules and biologics. She is chair of the AAPS CMC Community, and in addition to AAPS is also active on the ISPE Expedited... Read More →
avatar for J. Christopher Love

J. Christopher Love

Professor; Member, Koch Institute for Integrative Cancer Research, Koch Institute At MIT
J. Christopher Love is the Raymond A. (1921) and Helen E. St. Laurent Professor of Chemical Engineering and member of the Koch Institute for Integrative Cancer Research at MIT. Dr. Love received his Ph.D. in 2004 in physical chemistry at Harvard University. His research centers on... Read More →
avatar for Raj Puri

Raj Puri

Director, Division of Cellular and Gene Therapies, OTAT, CBER, FDA
Raj K. Puri, M.D., Ph.D. is a director of the Division of Cellular and Gene Therapies (DCGT) in the Office of Tissues and Advanced Therapies (OTAT) at FDA’s Center for Biologics Evaluation and Research (CBER). He has been directing this division for more than16 years. He is also... Read More →


Monday June 24, 2019 3:30pm - 4:30pm
Room 8 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Intermediate
  • Featured Topics Advanced Therapies
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session
 
Tuesday, June 25
 

8:00am

#217: Quality Considerations for Complex Generics
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-588-L04-P; CME 1.25; IACET 1.25; RN 1.25

Increasing the availability of complex generics is a major component of FDA’s recent efforts to enhance the affordability of medicines. The complexity of these products, which includes complex active ingredients, formulations, and drug-device combinations, make both their development and the associated regulatory review challenging. In this session, FDA and industry speakers will provide an introduction to the science and risk-based considerations for developing and reviewing these important products.

Learning Objectives

Discuss the definition and examples of complex generics; Describe considerations for the development of complex generics; Identify the challenges in regulatory review of complex generics.

Chair

Katherine Tyner, PhD

Speaker

Considerations for Manufacturing Assessment for Drug-Device Combination Products: Transdermal Systems and Intravaginal Rings
James Jefferis Norman, PhD

Strategies for Preparing High-Quality Submission of Generic Orally Inhaled Drug Products: Drug Product Quality Perspective
Fang Yuan, PhD

Regulatory and Scientific Challenges in Developing Generic Drug-Device Combination Products: An Auto Injector Case Study
Mike Darj, PhD

Regulatory and Scientific Challenges in Developing Generic Drug-Device Combination Products: An Auto Injector Case Study Part 2
Xiaohua Huang, PhD

Quality ANDA Considerations for Complex Generics: Industry Perspective
Scott Tomsky, MS



Speakers
MD

Mike Darj

Quality Assessment Lead (Acting), OLDP, OPQ, CDER, FDA
Mike has been with the Agency in various roles since 2003. He currently serves as Quality Assessment Lead (acting) in the Office of Lifecycle Drug Products of the FDA. Mike is also actively involved in working groups and expert committees as pertain to guidance and USP monograph developments... Read More →
avatar for Scott Tomsky

Scott Tomsky

Vice President, Regulatory Affairs, Generics, North America, Teva Pharmaceutical
Scott D. Tomsky is Vice President, Regulatory Affairs, Generics, North America at Teva. He has been actively involved in the pharmaceutical industry for more than 20 years. Scott has held various positions in R&D, Quality Control and Regulatory Affairs at Johnson and Johnson, Ranbaxy... Read More →
avatar for Katherine Tyner

Katherine Tyner

Associate Director for Science, Office of Pharmaceutical Quality, CDER, FDA
Dr. Katherine Tyner is the Associate Director of Science (acting) in the Immediate Office of the Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research at the United States Food and Drug Administration (FDA). As Associate Director, Dr. Tyner leads the OPQ... Read More →
FY

Fang Yuan

Chemistry Reviewer, OLDP, OPQ, CDER, FDA
Fang Yuan is a Drug Product Quality Reviewer in Office of Life Cycle Drug Product (OLDP), specialized in pre-market submissions of complex generics including oral inhalation and nasal, and long-acting injectable drug products. She is involved in reviewing pre-ANDA meeting packages... Read More →
XH

Xiaohua Huang

Chemist, Office of Lifecycle Drug Products, OPQ, CDER, FDA
Xiaohua serves as a review chemist in the Office of Lifecycle Drug Products of the FDA. His work at FDA involves the quality assessment of abbreviated new drug applications. Prior to joining FDA, he worked in the pharmaceutical industry including Schering-Plough and then Merck on... Read More →
avatar for James Norman

James Norman

Senior Chemist, OPF, OPQ, CDER, FDA
James Norman is a senior chemist in FDA’s Office of Process and Facilities. He joined FDA in 2015, where he primarily reviews complex combination products such as transdermal systems, intravaginal rings, and microneeedles. He completed his PhD in Chemical Engineering at Georgia... Read More →


Tuesday June 25, 2019 8:00am - 9:15am
Room 8 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

4:15pm

#297: Integration of Manufacturing Quality Assessment and Pre-Approval Inspections
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Application UAN: 0286-0000-19-642-L04-P; CME 1.25; IACET 1.25; RN 1.25

This session will discuss various case studies that illustrate the mechanism for risk-based holistic assessment of pharmaceutical manufacturing, and how such assessment leads to a thorough and timely assessment.

Learning Objectives

Describe the benefits of holistic pharmaceutical manufacturing assessment that involves closer alliance between drug product quality assessment and facility inspection; Recognize manufacturing risks that act as triggers for pre approval inspections.

Chair

Joanne Wang, PhD

Speaker

Integrated CMC Review and Inspection for a Combination Product: A Case Study
Nikolas Burlew

Proposal to Improve Risk-Based Regulatory Application Assessment
Roger Nosal, PhD

Regulatory Considerations for Manufacturing Assessment and Pre-Approval Inspections
Derek Smith, PhD



Speakers
avatar for Nikolas Burlew

Nikolas Burlew

Executive VP, RSD Global Consulting, Clinipace
Nik is a pharmaceutical professional with over twenty-seven years of experience in Drug Development, Manufacturing and Quality Assurance. He leads the Regulatory and Strategic Development Global Consulting group within Clinipace, Inc. which is focused on advancing drug and biologic... 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 Derek Smith

Derek Smith

Director, Div of Inspectional Assessment, OPF, OPQ, CDER, FDA
Derek Smith is the Director of the Division of Inspectional Assessment and the Acting Associate Director for Regulatory Affairs in the Office of Process and Facilities where he oversees the assessment of the manufacturing process and facilities for biologics and small molecule drug... Read More →
avatar for Joanne Wang

Joanne Wang

Acting Quality Assessment Lead, OPF, OPQ, CDER, FDA
Dr. Joanne Wang joined FDA in 2015 as a chemical engineer with expertise in drug delivery from complex devices, systems modeling, and in vivo superresolution imaging. She is currently the Acting Quality Assessment Lead in Branch IV, Division II of Office of Process and Facilities... Read More →


Tuesday June 25, 2019 4:15pm - 5:30pm
Room 8 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
 
Wednesday, June 26
 

8:00am

#315: Measuring and Assessing Product Manufacturing Quality
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-662-L04-P; CME 1.25; IACET 1.25; RN 1.25

Quality in pharmaceutical manufacturing is essential for patients but difficult to define and measure. This session will explore qualitative and quantitative approaches to assess the ability of manufacturers to make high quality medicines. Methodologies from FDA and Industry to measuring product and manufacturing quality will be discussed such as quality metrics and the New Inspection Protocol Project (NIPP).

Learning Objectives

Describe different methodologies to assessing product and manufacturing quality; Discuss the role of FDA’s Office of Pharmaceutical Quality (i.e., Office of Surveillance) in determining risks associated with manufacturing facilities and products; Identify the vision of how FDA programs can enhance risk-based regulatory oversight of manufacturing quality.

Chair

Giuseppe Randazzo, MS

Speaker

How FDA’s Office of Pharmaceutical Quality Applies Quality Surveillance to Assure Drug Quality
Karthik Iyer, MS

Panelist
Erin Fox, PharmD

Industry Perspective
Cylia Chen, MS



Speakers
CC

Cylia Chen

Director of Quality, Amgen
Cylia leads development of external engagement strategies for Amgen and is actively engaged with several industry associations such as PhRMA, BIO, PDA, RX-360, ISPE, and others. She is currently the co-leader of PDA Quality Metrics/Culture Task Force Team and have led a panel of experts... Read More →
avatar for Erin Fox

Erin Fox

Senior Director, Drug Information and Support Service, University of Utah Health
Erin directs the University of Utah Health Care Drug Information Service (UUDIS) and is adjunct associate professor at the UU College of Pharmacy. The UUDIS provides drug shortage content for the American Society of Health-System Pharmacists. Erin is recognized as an expert in drug... Read More →
avatar for Karthik Iyer

Karthik Iyer

Associate Director, CDER, FDA
Karthik is currently an associate director for Data and Analysis in the Office of Surveillance. Prior agency roles included CMC reviewer (Office of Process and Facilities), Acting Branch Chief ( Office of Surveillance) and Senior Policy Advisor (Office of Manufacturing and Product... Read More →
avatar for Giuseppe Randazzo

Giuseppe Randazzo

Director, Office of New Drug Products, OPQ, CDER, FDA
Giuseppe serves as Director of the Office of New Drug Products (ONDP) in CDER at FDA. ONDP is responsible for conducting risk and team-based, quality assessments of INDs, NDAs, and active pharmaceutical ingredient (API) information supporting NDAs and ANDAs. Giuseppe has been at the... Read More →


Wednesday June 26, 2019 8:00am - 9:15am
Room 8 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

10:30am

#339: Hot Topics in Quality and Regulatory Affairs for Combination Products
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-19-670-L04-P; CME 1.00; IACET 1.00; RN 1.00

Combination products are a hot topic in healthcare. These products combine two areas of medicine: medical devices and drugs/biologics. While these products open doors to exciting new possibilities in the medical world, they also bring new challenges.

This session will discuss the importance of promoting a culture of compliance to build a compliant lifecycle management infrastructure around combination products to ensure appropriate cGXPs and Quality System regulations are enforced throughout the franchise. Open discussions, case studies and dialogue will be included.

Learning Objectives

Discuss clinical trial to launch including regulatory expectations and differences for devices and drugs, how to manage parallel development programs and minimize risks for regulatory submissions; Outline best practice of handling adverse effects, usability concerns and complaints throughout drug/ device lifecycle; Describe how to establish an on-going and rigorous post-market surveillance strategy to identify product, design, and process improvement.

Chair

Rachel SW Turow, JD, MPH

Speaker

FDA Update
Melissa B. Burns, MS

Industry Perspective
James Wabby, MHS

Industry Perspective
Jim Kershner, MSc



Speakers
MB

Melissa Burns

Senior Program Manager, Office of Combination Products, FDA
Melissa Burns is a Senior Program Manager in FDA’s Office of Combination Products (OCP). In this role, she is responsible for coordinating activities related to combination product review and regulation including development and review of guidance documents, regulations, and procedures... Read More →
avatar for Rachel Turow

Rachel Turow

Executive Counsel, Regulatory Law, Teva Pharmaceutical Industries Ltd.
Rachel Turow is Executive Counsel – Regulatory Law at Teva Pharmaceuticals Ltd. In this role, Rachel provides regulatory legal support to Teva’s specialty and generic pharmaceutical businesses, and supports Teva’s drug-device combination products and digital health projects... Read More →
avatar for James Wabby

James Wabby

Executive Director, Regulatory Affairs, Devices and Combination Products, Allergan
James Wabby is the Executive Director of Regulatory Affairs (Device and Combination Products) at Allergan in Irvine, California. He has over 15 years of experience in increasing quality compliance and regulatory affairs responsibilities within the GxP regulated environment pertaining... Read More →
avatar for Jim Kershner

Jim Kershner

Human Factors Engineering Technical Lead, Eli Lilly and Company
Jim Kershner is a senior technical lead in the Human Factors group at Eli Lilly and Company. In this role, Jim was responsible for establishing the HF group at Lilly, and continues to drive human factors technical input in accordance with regulatory guidance, consensus standards... Read More →


Wednesday June 26, 2019 10:30am - 11:30am
Room 6B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

10:30am

#343: Efficient Preparation of Global CMC Dossiers
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-676-L04-P; CME 1.00; IACET 1.00; RN 1.00

Preparation and maintenance of dossiers for a global market is exceedingly complex, due to different expectations for regulatory agencies across the globe. Efficiently creating a dossier to effectively meet worldwide requirements requires careful planning. This session will provide some practical and pragmatic approaches for managing the complexity of global CMC dossiers.

Learning Objectives

Describe the key regulatory considerations for preparation of a global CMC dossier; Discuss some of the global harmonization efforts that are underway.

Chair

John Smart, PhD

Speaker

Global CMC Dossiers: Preparation is Key
Angela McGillivary, PhD

Regulatory CMC Roadmaps for Fast-Evolving Global Markets (Brazil, China, India, Russia and Turkey)
Monika Jain, PhD



Speakers
avatar for Monika Jain

Monika Jain

Manager , Regulatory Affairs CMC, Regulatory Development Solutions, PPD
Monika Jain, Ph.D. joined the pharmaceutical industry in 1996. She is an internationally accomplished regulatory Chemistry, Manufacturing and Controls (CMC) scientist, with a long- standing background in pharmaceutical research and development of small molecule drug products.Since... Read More →
avatar for Angela McGillivary

Angela McGillivary

Principal Consultant, PAREXEL
Angela is a Principal Consultant at PAREXEL and is an Emerging Markets Regulatory Affairs Professional with over 20 years’ experience in the Pharmaceutical Industry. Angela McGillivary PAREXEL, Principal Consultant Angela has worked with global cross functional teams to develop... Read More →
avatar for John Smart

John Smart

Senior Director and Group Manager, Regulatory CMC, AstraZeneca
John has a PhD in Chemistry and over 20 years’ experience of CMC development within AstraZeneca including roles in Analytical & Product Development and Project Management. John is currently a Senior Director in Regulatory CMC with responsibility for regulatory submissions from Phase... Read More →


Wednesday June 26, 2019 10:30am - 11:30am
Room 8 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

2:00pm

#370: Challenges and Opportunities in Product Quality: Lifecycle Management
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-699-L04-P; CME 1.25; IACET 1.25; RN 1.25

The efficacy and safety of a drug product are linked to its quality. Assuring product quality across the product lifecycle is challenging due to the numerous changes made to maintain or enhance product quality and manufacturing efficiency. Regulatory and industry speakers in this session will describe current thinking on product quality lifecycle management.

Learning Objectives

Describe FDA's current thinking on drug product quality lifecycle management, from brand name drugs to generics; Discuss specific tools and mechanisms in efficiently managing product lifecycle: Identify existing and upcoming regulatory tools to ease post approval changes.

Chair

Susan M. Rosencrance, PhD

Speaker

Lifecycle Management Challenges for Accelerated Program and Possible Innovative Solutions
Lucy Chang, PhD

Opportunities for Streamlining Postapproval Lifecycle Management Under ICH Q12
Isabelle Colmagne-Poulard, PharmD, MBA, MSc

Challenges and Opportunities in Lifecycle Management of Product Quality
Hasmukh B. Patel, PhD



Speakers
avatar for Isabelle Colmagne-Poulard

Isabelle Colmagne-Poulard

Senior Director, Regulatory CMC, GRA and Quality Assurance, Merck Serono
Isabelle has joined Merck Serono since 2005 where she held growing managerial roles in RA and RA CMC as Head of Department. She is actively involved in regulatory CMC intelligence as member of IFPMA Biotherapeutics WG and IFPMA Regulatory Strategy Committee since 2015. She takes part... Read More →
avatar for Susan Rosencrance

Susan Rosencrance

Director, Office of Lifecycle Drug Products, OPQ, CDER, FDA
Dr. Susan Rosencrance presently heads FDA's Office of Lifecycle Drug Products within the Office of Pharmaceutical Quality (OPQ). She provides executive leadership by overseeing and directing scientific review programs and activities related to evaluating drug product quality throughout... Read More →
avatar for Lucy Chang

Lucy Chang

Exceutive Director, Merck & Co., Inc.
Dr. Chang received her Ph.D. from University of Connecticut and has worked in various biopharm companies including Sanofi, GSK, Pfizer and Teva. She is currently the Executive Director of Global Regulatory CMC, providing regulatory leadership, oversight and strategy to a team of Regulatory... Read More →
avatar for Hasmukh Patel

Hasmukh Patel

Director of Division of Post-Marketing Activities I, OLDP, OPQ, CDER, FDA
Dr. Hasmukh Patel is the Division Director in the Division of Post-Marketing Activities 1 (for NDAs) in the Office of Lifecycle Drug Products (OLDP), OPQ, CDER. He is with the FDA for more than 20 years. Dr. Patel has extensive technical, regulatory and managerial experience. His... Read More →


Wednesday June 26, 2019 2:00pm - 3:15pm
Room 8 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

4:15pm

#393: Case Studies in Resolving Quality Issues
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Application UAN: 0286-0000-19-715-L04-P; CME 1.25; IACET 1.25; RN 1.25

Getting a drug approved is challenging, but it is even harder when the drug developer or manufacturer is inexperienced with regulatory agencies, the process following an inspection, and expectations from regulatory authorities. This session presents specific examples of how to recover from unsuccessful inspections and/or complete response action.

Learning Objectives

Identify some of the pitfalls that can happen during the drug development and initial manufacturing; Describe methodologies for resolving deficiencies in manufacturing and enhancing assurance of product quality.

Chair

Milind Ganjawala, MBA, MS

Speaker

Preparing Global CMC Dossiers when Faced with Challenging Corporate Milestones and Manufacturers Inexperienced with ICH/GMP
Duu-Gong Wu, DrSc, PhD

A Small US Drug Manufacturing Company’s Journey from Complete Response to NDA Approval
Daniel M. Bollag, PhD

FDA Update
Derek Smith, PhD



Speakers
avatar for Daniel Bollag

Daniel Bollag

Senior Vice President, Regulatory Affairs and Quality, Ocular Therapeutics
Dr. Bollag joined Ocular Therapeutix in August 2017 as Senior Vice President of Regulatory Affairs and Quality. He held a similar role at ARIAD Pharmaceuticals from 2009 - 2017 where he oversaw the accelerated registrations of ICLUSIG (ponatinib) indicated for chronic myeloid leukemia... Read More →
avatar for Derek Smith

Derek Smith

Director, Div of Inspectional Assessment, OPF, OPQ, CDER, FDA
Derek Smith is the Director of the Division of Inspectional Assessment and the Acting Associate Director for Regulatory Affairs in the Office of Process and Facilities where he oversees the assessment of the manufacturing process and facilities for biologics and small molecule drug... Read More →
DW

Duu-Gong Wu

Senior Director, Global Regulatory Affairs, PPD
Dr. Duu-Gong Wu is Senior Director of Regulatory Consulting at PPD with expertise in biosimilar regulatory and technical strategy. He previously worked at US FDA with the last position as Deputy Division Director at CDER, before joining PharmaNet/i3, then PPD. His experience included... Read More →
MG

Milind Ganjawala

Supervisory Consumer Safety Officer, OMQ, OC, CDER, FDA
Mr. Ganjawala serves as the Division Director of the Division of Drug Quality 2 (DDQ2), Office of Manufacturing and Product Quality (OMPQ), Office of Compliance (OC), Center for Drug Evaluation and Research (CDER), FDA. Prior to coming to FDA, Mr. Ganjawala spent more than 20 years... Read More →


Wednesday June 26, 2019 4:15pm - 5:30pm
Room 8 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
 
Thursday, June 27
 

9:00am

#411: Recent CMC Changes in Emerging Regulatory Agencies
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-727-L04-P; CME 1.25; IACET 1.25; RN 1.25

The international regulatory landscape is changing rapidly as more regulatory agencies are maturing their regulatory systems, defining their regulatory expectations, and aligning with other regulators through organizations such as ICH and PIC/S. This session will focus on recent developments in Chemistry, Manufacturing and Controls (CMC) and inspections for emerging health authorities. Invited regulatory speakers are from China’s NMPA, South Korea’s MFDS, and Russia’s Ministry of Industry and Trade. Speakers will address current regulatory changes and harmonization efforts related to dossier content, inspections, and pharmacopeia alignment.

Learning Objectives

Discuss recent changes in regulations by emerging regulatory agencies; Identify efforts to harmonize regulatory systems for oversight of pharmaceutical quality.

Chair

Nirdosh Jagota, PhD

Speaker

Perspective from Korea
YoungLim Kim, PhD

Russian Regulatory System in the Field of Medicines and its Potential Harmonization with International Requirements
Tatiana Nikolko

Industry Perspective on China
Chi-Wan Chen, PhD



Speakers
avatar for Chi-Wan Chen

Chi-Wan Chen

Executive Director, Global CMC, Pfizer Inc
Dr. Chi-wan Chen is Executive Director in Global CMC, Pfizer, responsible for regulatory CMC policies and strategies with a focus on China and Asia Pacific. She has made numerous presentations on regulatory and CMC topics on China in these countries. Prior to joining Pfizer in 2008... Read More →
avatar for Nirdosh Jagota

Nirdosh Jagota

Vice President and Head, Regulatory CMC, Merck & Co., Inc.
Nirdosh Jagota serves as VP and Head of CMC, Global Regulatory Affairs at Merck. Nirdosh has 26 years of pharmaceutical industry experience including 21 years in global regulatory management. Prior to Merck, he was VP, Regulatory CMC at Genentech/Roche. Before joining Genentech/Roche... Read More →
avatar for YoungLim Kim

YoungLim Kim

Director, Ministry of Food and Drug Safety (MFDS)
Dr. Kim has been working at MFDS for more than 26 years. She is Director of the Gastroenterology and Metabolism Products Division, Drug Evaluation Department. Before that, Dr. Kim was Director of the Pharmaceutical Standardization Division, Deputy director and Reviewer of the Oncology... Read More →
TN

Tatiana Nikolko

Deputy Head of Inspections Department, State Institute of Drugs and Good Practices


Thursday June 27, 2019 9:00am - 10:15am
Room 8 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA