Regulatory Affairs Professionals Society Presents
Chemistry, Manufacturing and Controls Workshop in Philadelphia
18 October 2011
Rockville, MD, USA—Chemistry, Manufacturing and Controls (CMC) is one of the three key areas—along with safety and efficacy—that regulatory agencies, including the US Food and Drug Administration, consider in reviewing New Drug Applications. It is critical for regulatory professionals to understand key CMC concepts and to cultivate strong partnerships with others working on CMC-related areas within their organizations. The Regulatory Affairs Professionals Society (RAPS) will host a two-day workshop on this topic to help regulatory professionals get the critical skills and insight required to develop effective CMC strategies. RAPS’ CMC Workshop: Key Implications for Regulatory Professionals and Their Role as Business Partners will take place 14–15 November at the Radisson Plaza-Warwick Hotel in Philadelphia.
CMC experts will address key CMC concepts, including:
- The impact of eCTD for the CMC professional
- Quality by Design for drug substances and drug products
- Quality module insight
- ICH initiatives for biotech and specialty pharmaceuticals
- How mergers and acquisitions affect CMC
- Regulatory and supply chain support of generics filings worldwide
- CMC considerations for biologics
- CMC challenges associated with gene therapy and cell or tissue therapeutics
- Genotoxic impurities
Workshop speakers include Lani Cammack, director, GPRA CMC, Abbott Laboratories; Deanna Murden, president, ePharmaCMC LLC; Edward Narke, MS, founder, Design Space InPharmatics; Ambarish K. Singh, PhD, associate director, global regulatory sciences-CMC, Bristol-Myers Squibb; Chand Sishta, PhD, RAC, senior principal scientist, Global CMC, Pfizer; Timothy Watson, PhD, associate research fellow, GCMC Advisory Office, Pfizer; David Ziering, PhD, director, regulatory CMC, Bristol-Myers Squibb.
Watson will have just returned from the International Conference on Harmonisation (ICH) Q11 Expert Working Group’s November meeting in Seville, Spain, and will offer a first look at the group’s discussions there.
For more information and the full agenda, visit http://www.raps.org/education-amp-training.aspx.
On a related note, RAPS recently announced a new CMC course offered through RAPS Online University, RAPS’ respected online regulatory learning platform. The course presents an examination of the CMC section of dossiers.
The Regulatory Affairs Professionals Society (RAPS) is an international membership organization of regulatory professionals in the rapidly growing medical device, pharmaceutical and biotechnology sectors. Regulatory professionals play vital roles in making better healthcare products possible. They work throughout the healthcare product lifecycle, ensuring these products are safe and effective, while driving organizational strategy and sound decision-making. RAPS supports these individuals and the regulatory profession by providing education and training, Regulatory Affairs Certification (RAC), professional standards, research, knowledge-sharing, publications, networking, career development opportunities and other valuable resources; and is committed to helping its members continually develop the knowledge and skills they need to excel. RAPS is headquartered near Washington, DC, with offices in Brussels and Tokyo.