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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

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
    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 Director, Global CMC
    Pfizer Pharmaceuticals, Inc., United States
  • Ganapathy  Mohan, PhD
    Ganapathy Mohan, PhD Head of Global CMC
    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 Former Vice President, CMC Strategy
    GlaxoSmithKline, United States
  • Peter  Richardson, PhD
    Peter Richardson, PhD Head of Quality, Specialised Scientific Disciplines Department
    European Medicines Agency (EMA), United Kingdom
  • Jean-Louis  Robert, PhD
    Jean-Louis Robert, PhD Former CHMP/CVMP QWP Chair
  • Ramesh K. Sood, PhD
    Ramesh K. Sood, PhD Senior Scientific Advisor (Acting), Office of New Drug Products, CDER
    FDA, United States
  • Thirunellai G Venkateshwaran, PhD
    Thirunellai G Venkateshwaran, PhD AVP Regulatory Affairs CMC Biologics
    Merck, United States
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Contact us

Printable Registration Form

Registration Questions
Toll Free 1.888.257.6457
Phone +1.215.442.6100
Fax +1.215.442.6199
Monday-Friday 8:30AM-8:00PM ET

Agenda Details
Rachel Minnick, Content Lead
Phone +1.215.442.6131
Fax +1.215.442.6199

Event Logistics
Susan Berkelbach, Event Planner
Phone +1.215.442.6183
Fax +1.215.442.6199

Exhibit Details
Jessica Culp, Exhibit & Event Logistics Associate 
Phone +1.215.442. 6132
Fax +1.215.442.6199 

Digital Learning Catalog

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