Horsham, Pa. (PRWEB) April 11, 2013
DIA will host its biannual CMC Workshop: From Drug Development to Global Supply to Patients at the Washington Marriott hotel in Washington, D.C., April 15 to 17. Developed by the Chemistry, Manufacturing & Controls/Quality System Community (CMC) and co-sponsored by the American Association of Pharmaceutical Scientists, the workshop will focus on challenges in the global pharmaceutical and biopharmaceutical arenas. Attendees from various CMC areas will interact with peers from regulatory agencies and industry in sessions fostering cross-functional discussions.
“We’re excited to provide this two-day event, which will offer invaluable information and knowledge to every attendee,” said Susan Cantrell, director of DIA North America. “Our program will have the highest-level thought leaders from across the globe delivering the most relevant content in each session of this meeting.”
The following members of the program committee will be presenting at the meeting to provide unparalleled insight into a variety of CMC areas:
- Lin-Jau (Christine) Wu Anderson, M.S., RAC
Senior Research Scientist, Global Regulatory Affairs CMC
Eli Lilly and Company, United States
- Nagesh Bandi, Ph.D.
Senior Manager, Global CMC
Pfizer Inc., United States
- Yasmin de Faria Krim, Pharm.D., M.Sc.
Regulatory Affairs Manager, Global CMC
Janssen Pharmaceutical Companies of Johnson & Johnson, Belgium
- Ganapathy Mohan, Ph.D.
Executive Director, Global CMC, Pharmaceutical and Devices
Merck Sharp & Dohme Corp., United States
- Elaine Morefield, Ph.D.
Deputy Office Director for Review and Operations in the Office of New Drug Quality Assessment, Center for Drug Evaluation and Research
Food and Drug Administration, United States
- Peter J. Richardson, Ph.D.
Head of Biologics, Quality of Medicines Sector
European Medicines Agency, European Union, United Kingdom
- Jean-Louis Robert, Ph.D.
Head, Medicines Control Laboratory
National Health Laboratory, Luxembourg
- Thirunellai G. Venkateswaran, Ph.D.
Director, Pharmaceutical Technical Regulatory
Genentech, A Member of the Roche Group, United States
With sessions covering critical topics such as Globalization in the CMC Area – Collaboration Between Regulatory Agencies, and Impurities – Genotoxic Impurities to Clinical Trials in the European Union (Biologicals), the agenda will be of great importance to participants working in:
- Analytical development
- Active pharmaceutical ingredient development and manufacturing
- CMC life cycle management
- CMC project management
- CMC regulatory affairs
- CMC writing
- Formulation development and manufacturing
- Quality assurance/quality control
- Regulatory compliance
ABOUT DIA: DIA is a neutral, global, professional and member-driven association of nearly 18,000 professionals involved in the discovery, development and life cycle management of pharmaceuticals, biotechnology, medical devices and related health-care products. Through our international educational offerings and myriad networking opportunities, DIA provides a global forum for knowledge exchange that fosters the innovation of products, technologies and services to improve health and well-being worldwide. Headquarters are in Horsham, Pa., USA, with offices in Basel, Switzerland; Tokyo, Japan; Mumbai, India; Beijing, China; Washington, D.C., and Latin America. Visit our website at diahome.org and follow DIA at: LinkedIn, Twitter, YouTube, Facebook, Flickr and Pinterest.