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April 23: Short Course*: Regulatory CMC Training - The Basics to Prepare for the CMC Workshop
April 24-26: Workshop

*Short Courses require separate registration.

Why come to DIA's CMC Workshop over any other CMC event?

  1. This workshop has a laser focus on regulatory applications and translations to technical and quality processes – the strategy behind the science. How do regulations and guidelines inform the processes of this industry? This is the setting to find out.
  2. One word: global. We will facilitate discussions with a highly global, regulatory focus, concentrating on regulations and guidelines from multiple ICH and non-ICH regions by regulatory authorities from those regions.
  3. Multi-track. One track and one focus will not cut it for DIA. This is truly comprehensive content that will meticulously cover regulatory, technical, and GMP/Quality processes and how they work together.
  4. No important topic unturned. We will address a broad array of innovative products: drugs (small molecule), complex products/generics, large molecules (biologics), biosimilars, and drug device combination products. This is unprecedented in any other offerings this year! No other meeting will have this scope and depth!

Through three parallel tracks, DIA’s CMC Workshop will provide a thorough understanding of the regulatory, technical, and quality requirements and strategies needed to support problem-solving as well as continuous improvements and innovation in biopharmaceutical manufacturing.  Opportunities for interactive sharing of information and approaches will be an important part of the program.

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

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

New This Year

  • Preconference Short Course to prepare entry and early intermediate level professionals for the workshop content
  • 3 concurrent breakouts covering the topical themes of: GMP/Quality, Regulatory/Dossier, and Technical Aspects of CMC
  • 22 sessions, including four plenary sessions in: Accelerated Programs, Innovative Technologies with a focus on Continuous Manufacturing, Life Cycle Management using ICHQ12, and the Global Regulators Update
  • 18 breakouts – these are complete sessions addressing the three topical themes

Hot Topics

  • Addressing regulation, development, and technical issues for large and small molecules
  • Global perspectives: Regulatory and industry representation on requirements and issues from major global regions: US, EU, Japan, Asia-Pacific, Latin America, and Middle East (View DIA's complimentary webinars on CMC Regulatory Requirements in Sub Saharan Africa and Maghreb
  • Case studies and interactive discussions to address the CMC challenges for today’s products

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 Worshop, participants should be able to:

  • Discuss the current CMC topics for chemical and biological products in a globalized environment
  • Explain challenges and opportunities for accelerated drug development
  • Describe recent ICH updates
  • Compare challenges in the area of drug delivery devices
  • Outline challenges in preventing falsified medicines in a global landscape
  • Assess current situation for biosimilars approval
  • State regulatory updates in international markets
  • Discuss process monitoring for CMC

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
  • Lynn  Gold, PhD
    Lynn Gold, PhD Vice President of Scientific and Regulatory Affairs
    Camargo Pharmaceutical Services, LLC, 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 (EMA), United Kingdom
  • Jean-Louis  Robert, PhD
    Jean-Louis Robert, PhD Former CHMP/CVMP QWP Chair
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Short Course

Regulatory CMC Training - The Basics to Prepare for the CMC Workshop

Complimentary Webinars: CMC Regulatory Requirements in

Sub Saharan Africa and Maghreb

Exhibit Information

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DIA Learning: 2018 eLearning Soultions