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Hyatt Regency Bethesda

Apr 13, 2015 7:00 AM - Apr 15, 2015 12:00 PM

One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814-5326

CMC Workshop 2015

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

Want to learn more about CMC Workshop 2015? You've come to the right site!

Continuing-Education

Exhibits

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
    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
    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
    Nagesh Bandi, PhD Executive Director
    Merck & Co., Inc, United States
  • Ganapathy  Mohan, PhD
    Ganapathy Mohan, PhD Head of External Affairs (Quality)
    Merck & Co., Inc., United States
  • Elaine  Morefield, PhD, RPh
    Elaine Morefield, PhD, RPh Vice President, Regulatory Affairs
    VaxForm, LLC., United States
  • Moheb M. Nasr, PhD, MS
    Moheb M. Nasr, PhD, MS Principal
    Nasr Pharma Regulatory Consulting, United States
  • Peter  Richardson, PhD
    Peter Richardson, PhD Head of Quality, Specialised Scientific Disciplines Department
    European Medicines Agency, Netherlands
  • Jean-Louis  Robert, PhD
    Jean-Louis Robert, PhD Former CHMP/CVMP QWP Chair
    Luxembourg
  • Ramesh K. Sood, PhD
    Ramesh K. Sood, PhD Senior Scientific Advisor (Acting), Office of New Drug Products, CDER
    FDA, United States
  • T.  Venkateshwaran, PhD
    T. Venkateshwaran, PhD Vice President and Global Head CMC Biologics, Medical Devices and Comb
    Merck & Co., Inc., United States

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