An Interactive Analysis with Industry and FDA
12 January 2010 | RAPS Training Center | Rockville, Maryland
Can't attend on site? Consider attending virtually! Learn more »
On 23 September 2009, the US FDA proposed rules to codify current Good Manufacturing Practices (cGMPs) for combination products. This highly anticipated proposed rule will have significant implications for entities that develop and commercialize combination products.
Offered in collaboration with the Combination Products Coalition (CPC), this program offers the unique opportunity to examine the contents of the proposed rule and the agency’s implementation plan with representatives from FDA’s Office of Combination products and industry peers. In didactic lectures, you will hear directly from FDA and industry regarding what the proposed rule includes and how it may affect you and your company. Working in intensive, small groups, you will apply the proposed rule using a case study approach to analyze the rule’s strengths, weaknesses, ambiguities, unintended consequences and more. RAPS will compile the major themes that emerge from the program and submit them as comments to the proposed rule.
The comment period ends 5 February 2010; don’t miss your opportunity to provide your input on this pivotal rule!
Learning Objectives
At the conclusion this program, participants should be able to:
- Explain how the proposed rule may impact their business and operations
- Identify aspects of the rule for which you may need to seek clarification
- Assess potential implementation plans needed to achieve compliance with CGMPs for combination products
Who Should Attend?
This program is intended for manufacturers (including contract manufacturers), combination product developers, consultants and legal counsel who are involved in regulatory, quality and compliance at all professional levels.
Speakers
Leighton Hansel, director, regulatory affairs, Abbott quality and regulatory, Abbott Laboratories
Tom Hutchinson, vice president, quality assurance, CR Bard Inc.
Nancy Kazantzis, MBA, senior principal scientist, global chemistry, manufacturing and controls, Pfizer
Thinh Nguyen, director, Office of Combination Products, US Food and Drug Administration
John (Barr) Weiner, JD, associate director for policy and product classification officer, Office of Combination Products, US Food and Drug Administration