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DIA TO HOST CMC Workshop: From Drug Development to Global Supply to Patients

WASHINGTON — Apr 09, 2013

DIA will host its bi-annual CMC Workshop: From Drug Development to Global Supply to Patients at the Washington Marriott Hotel in Washington, DC, April 15-17. The two days will focus on current challenging topics within the global pharmaceutical/biopharmaceutical arena. Similar to the successful 2011 CMC Workshop, attendees from the different 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.  Our program will have the highest level thought leaders from across the globe delivering the most relevant content in each session of this meeting.” said Susan Cantrell, Director, North America at DIA.

This program was developed by the Chemistry, Manufacturing & Controls/Quality System Community and is co-sponsored by the American Association of Pharmaceutical Scientists.

The following, members of the program committee, will be presenting throughout the two-day meeting to provide unparalleled insight into a variety CMC areas:

  • Yasmin de Faria Krim, PharmD,MSc
    Global CMC Regulatory Affairs Manager
    Janssen Pharmaceutical Companies of Johnson & Johnson, Belgium
  • Lin-Jau (Christine) Wu Anderson, MS,RAC
    Senior Research Scientist, Global Regulatory Affairs CMC
    Eli Lilly and Company, United States
  • Nagesh Bandi, PhD
    Senior Manager, Global CMC
    Pfizer Pharmaceuticals, Inc., United States
  • Ganapathy Mohan, PhD
    Executive Director Global CMC, Pharmaceutical and Devices
    Merck, Sharp and Dohme, Corp., US, United States
  • Elaine Morefield, PhD
    Deputy Office Director, Office of New Drug Quality Assessment, CDER
    FDA, United States
  • Peter J Richardson, PhD
    Head of Biologics, Quality of Medicines Sector
    European Medicines Agency, European Union, United Kingdom
  • Jean-Louis Robert, PhD
    Head, Medicines Control Laboratory
    National Health Laboratory, Luxembourg
  • Thirunellai G Venkateshwaran, PhD
    Director Pharma Technical Regulatory
    Genentech, A Member of the Roche Group, United States

With sessions ranging from Globalization in the CMC Area - Collaboration Between Regulatory Agencies, to Impurities - Genotoxic Impurities to Clinical Trials in the European Union (Biologicals) the agenda will prove to be of great importance to those working 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

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ABOUT DIA: DIA is the global connector in the life sciences product development process. Our association of more than 18,000 members builds productive relationships by bringing together regulators, innovators and influencers to exchange knowledge and collaborate in an impartial setting. DIA’s network creates unparalleled opportunities for the exchange of knowledge and has the interdisciplinary experience to prepare for future developments. The dedicated efforts of DIA staff, members and speakers enable DIA to provide a comprehensive catalogue of conferences, workshops, training courses, scientific publications and educational materials. DIA is a global community representing thousands of stakeholders working together to bring safe and effective products to patients. DIA is an independent, nonprofit organization with its global center in Washington, D.C., USA; regional offices covering North and South America (Horsham, Penn., USA); Europe, North Africa and the Middle East (Basel, Switzerland); and Japan (Tokyo), India (Mumbai) and China (Beijing). For more information, visit www.diahome.org.