2009 PDA/FDA Joint Regulatory Conference
Don't miss hearing Dr. Joshua Sharfstein, Principal Deputy Commissioner of FDA
Securing the Future of Medical Product Quality: A 2020 Vision
September 14-18, 2009 | Renaissance Hotel | Washington, D.C.
Overview
The PDA/FDA Joint Regulatory Conference offers the unique opportunity for you to join FDA representatives and industry experts in face-to-face dialogues. Each year, FDA speakers provide updates on the current state of efforts impacting the development of global regulatory strategies; while industry professionals from some of today’s leading pharmaceutical companies present case studies on how they employ global strategies in their daily processes.
Hear directly from FDA experts and representatives of global regulatory authorities, and take home best practices for compliance. You won’t find this level of direct information exchange with FDA at any other conference!
PDA is also offering an exhibition during the conference, September 14-15. The PDA Training and Research Institute (PDA TRI) will host courses immediately following the conference, September 17-18, to complement what you learn at the meeting.
2009 ISPE Annual Meeting
Thriving in a Survival Environment
ISPE proudly presents this year’s selection of education sessions and other “can’t miss” events taking place at 2009 Annual Meeting, 8-11 November, San Diego, California, USA. Our theme is Thriving in a Survival Environment, and this sentiment, as well as Annual Meeting itself, represents what ISPE is about, and what ISPE does better than any other industry association.
8-11 November, San Diego, California, USA Choose from education sessions in one or more of 11 different tracks. These sessions, plus the keynote addresses, and other critical events will share ways for us to work smarter and thrive, even when in survival mode. Thanks to our sponsors: Parsons (Platinum), Pharma BioServ (Platinum), Stantec (Platinum), CH2M Hill (Gold), Commissioning Agents (Gold), Komtur Pharmaceuticals (Gold), Pharmadule (Gold), Burns & McDonnell (Silver), Emerson Process Management (Silver), Camfil Farr (Tuesday Night Party Sponsor), Farr APC (Tuesday Night Party Sponsor), SNC-Lavalin (Hotel Key Cards), Intergraph Corporation (Lanyards), and NNE Pharmaplan (Tote Bags).
103 - Combination Products: Considerations for Entering a New Market 8 November 13.00-17.00What does it take for pharmaceutical, medical device, and biologics companies to enter the market of Combination Products (CP)? Using case studies and real-world problem solving techniques, you can learn from the successes and failures of those that have already undergone this process. The overlapping elements of traditional pharmaceutical product development stage gates, and medical device product development prescribed by design controls create challenges for development scientists, quality, regulatory, and operations professionals in the development of a CP.
This session will focus on:
- Product development challenges
- Impact and incorporation of product development aspects of medical device in a pharmaceutical product and pharmaceutical development in the medical device design control process
- Regulatory submission considerations for CP
- Business strategy for entering the CP market using a case study approach
- A comprehensive understanding of the topic through a panel question and answer discussion
- Teresa Kuan, Manager, Quality Assurance, Allergan Inc USA
- Philip Russ, Principal Consultant, Innovative Consultants GXP USA
- Susan Slane, DVP, Global Quality & Compliance, Abbott USA