Overview

This workshop, through plenary and parallel breakout sessions, will focus on current challenging topics within the global pharmaceutical/biopharmaceutical arena. Attendees from different CMC areas will be given the opportunity to interact with representatives from global Regulatory Agencies and Industry in sessions enabling cross-functional discussions.

This program was developed by the CMC Working Group of the DIA Regulatory Affairs Community.

This program is co-sponsored by the American Association of Pharmaceutical Scientists.

Featured topics

Featured Session Topics:

Life Cycle Management
Post-approval Change Management Protocols
Elemental Impurities
Control Strategy Approaches for Drug Substance and Drug Product
Breakthrough Therapies
FDA/EMA QbD Pilot Program Update
Implementation of QbD
Risk Management for Biologicals
Updates from Regulatory Agencies (Dossier Review/Inspections)

Sessions will feature Regulatory speakers from FDA, EMA, PMDA, Health Canada and ANVISA

Featured

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Who should attend?

Professionals involved in:

CMC Regulatory Affairs
CMC Writing
Quality Assurance/Quality Control
Regulatory Compliance
API Development and Manufacturing
Formulation Development and Manufacturing
Analytical Development
CMC Life Cycle Management
CMC Project Management

Learning objectives

At the conclusion of this workshop, participants should be able to:

Discuss the current CMC topics for chemical and biological products in a globalized environment
Explain current issues in the area of life cycle management
State updates in the post-approval regulatory landscape in Latin America and Asia Pacific
Explain the current situation in the area of QbD and its implementation
Discuss control strategy, continuous manufacturing, and process validation
Indicate recent initiatives for quality metrics, breakthrough therapies, and risk-based review
Recognize issues in the development of pediatrics
Describe the implementation of global standards for control of elemental impurities

Program Committee

Yasmin de Faria Krim, PHARMD, MSC CMC working group
Chair, CMC Working Group, DIA Regulatory Affairs Community, France
Lin-Jau (Christine) Wu Anderson, BSN, MSC, RAC Senior Research Scientist, Global Regulatory, Chemistry, Manufacturing & Control
Eli Lilly and Company, US, United States
Nagesh Bandi, PHD Executive Director
Merck & Co., Inc, United States
Ganapathy Mohan, PHD Head of External Affairs (Quality)
Merck & Co., Inc., United States
Elaine Morefield, PHD, RPH Vice President, Regulatory Affairs
VaxForm, LLC., United States
Moheb M. Nasr, PHD, MS Principal
Nasr Pharma Regulatory Consulting, United States
Dr. Peter Richardson, PHD Head of Quality, Specialised Scientific Disciplines Department
European Medicines Agency, Netherlands
Jean-Louis Robert, PHD Former CHMP/CVMP QWP Chair
Luxembourg
Ramesh K. Sood, PHD Senior Scientific Advisor (Acting), Office of New Drug Products, CDER
FDA, United States
T. Venkateshwaran, PHD Vice President and Global Head CMC Biologics, Medical Devices and Comb
Merck & Co., Inc., United States

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