TAMPA, FL, October 1-ISPE, a global not-for-profit association of 25,000 pharmaceutical science and manufacturing professionals, has announced its full line-up of regulatory speakers presenting at the 2008 ISPE Annual Meeting, to be held October 26-29, in Boca Raton, Florida.

“We couldn’t be more excited about the significant contributions we are getting this year from experts representing the world’s regulatory agencies,” says Doug Ellsworth, ISPE’s international regulatory affairs advisor.” This will truly be an opportunity for pharmaceutical professionals to learn first-hand about emerging global industry trends and practices.”

In addition to the wide variety of presenters from top pharmaceutical companies such as Abbott, AstraZeneca, Bristol-Myers Squibb, Johnson & Johnson, Schering Plough, Vetter and Wyeth, attendees will have the opportunity to interact with representatives of international regulatory agencies during the following discussions:

  • Janet Woodcock, director of the Center for Drug Evaluation and Research at the FDA will be delivering a keynote address.

  • Product Quality Lifecycle Implementation (PQLI) and a practical approach to global implementation of ICH documents. Regulators confirmed for this session: Yukio Hiyama (NIHS), Frank Holcombe (FDA), Jacques Morenas (AFSSA PS, France), Moheb Nasr (US FDA), Jean-Louis Robert (EMEA), and Joe Famulare (US FDA).

  • Risk-MaPP and use of risk-based techniques to manage cross contamination. Regulators confirmed for this session: Tor Graberg (PIC/S).

  • Financial, legal, technical and regulatory issues facing biosimilars. Regulator confirmed for this session: Dr. Anthony Ridgway (Health Canada).

  • Quality Laboratory Facilities Baseline Guide: A Roadmap to a Compliant, Cost-effective Lab. Regulator confirmed for this session: Fred Fricke (FDA).

  • Competing in the Global Marketplace. Regulator confirmed for this session: Ali Afnan (FDA).

  • Hot Topics in Process Validation. Regulator confirmed for this session: Rick Friedman (FDA).

    Education sessions at the 2008 ISPE Annual Meeting will follow seven tracks of interest: Regulatory, Innovation, Manufacturing Operations, Engineering Design, Investigational Products, Project Management, and Efficient and Effective Compliance. Networking activities, exhibits and special events also will allow for one-on-one time with colleagues for further knowledge and best practice sharing.

    For information, visit www.ISPE.org/annualmeeting.