Thursday, February 22, 2018, 6:00 PM – 9:30 PM PST
Oyster Point Yacht Club, 911 Marina Boulevard, South San Francisco, CA 94080
Changes are a common and unavoidable part of a product's lifecycle. Pharmaceutical and biotechnology companies routinely make post-approval changes (PACs) and updates to a drug's manufacturing and operating systems to improve the therapy and ensure safe, reliable and compliant production and distribution.
A product Marketing Authorization Holder (MAH) can introduce manufacturing changes as part of continual improvement to enable implementation of innovative technologies, exchange obsolete equipment, improve the availability of drug products for patients, or to comply with evolving regulatory requirements.
Manufacturers are encouraged by regulatory authorities to make such revisions, innovations and upgrades; however, companies are often deterred by the amount of time, cost and complexity necessary to report such alterations, as harmonized standards for post-approval change control are limited.
During this dinner meeting our speaker will discuss and share her knowledge about the current challenges of PACs and then focus on Roche Product Lifecycle Management strategy, elements and benefits of such strategy and its use in post-approval change management to enable effective communication and knowledge sharing with health authorities.
Emma Ramnarine is Senior Director, Head Global Analytical Science & Technology (gASAT) at Genentech/Roche, and is accountable for the Biologics QC network strategy including lifecycle management of analytical control systems, stability, raw materials management, and adventitious agent testing.
Emma has over 15 years of experience in the pharmaceutical, biotechnology and medical device industry in the area of Quality System with focus on developing and leading Quality Risk Management (QRM), validation, and change control.
She is a worldwide-recognized expert on QRM, providing QRM leadership, governance, guidance, and training to regulatory authorities and at industry forums. Emma has been an active member of the Parenteral Drug Association (PDA) for 13 years. She most recently led PDA"s Task Force for Technical Report No. 68 on "Risk Based Approach for Prevention and Management of Drug Shortages", and is also a member for PDA on the inter-association European Drug Shortages Team that was formed under EMA"s direction.
She also led the Task Forces for PCMOSM Technical Report Series No. 54 on "Implementation of Quality Risk Management". Emma joined the PDA Board of Directors as of Jan 2015, has been on PDA"s Regulatory Affairs and Quality Advisory Board (RAQAB) since 2013, and also co-leads PDA"s QRM Interest Group.
Emma holds an M.S. in Pharmaceutical Sciences from University of Connecticut, an M.S. in Medicinal & Pharmaceutical Chemistry, and a B.S. in Pharmacy, both from University of Indore, India.
6:00 PM Registration/Networking*
7:00 PM Complementary Dinner (buffet)
7:45 PM Announcements
8:00 PM Presentation/Q&A
9:30 PM Closing
*No host bar
PDA Members - $60
Nonmembers - $70
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