AGAH April, 2011

AGAH Dermatology Product Development, April 28–29, 2011, Hilton Short Hills, Short Hills, NJ

This is a two-day international workshop that bioskin is organizing and sponsoring on behalf of the Arbeitsgemeinschaft für angewandte Humanpharmakologie e.V (AGAH) – Association for Applied Human Pharmacology. The purpose of this workshop is to address many of the key issues and challenges involved in the successful development of dermatological products from formulation onwards. Practical guidance will be given as well as discussion of strategies and regulatory requirements.

The workshop is intended for all of those interested or involved in the development of dermatologicals, whether these are NCEs, known actives in new formulations or generic drug products.

Key highlights of the program include:
  • Candidate selection, challenges in formulations and best use of in vitro penetration
  • Pre-clinical strategy and requirements (including an industry perspective on what is special for the development of topicals and requirements from a European regulator's view)
  • Translational research (accelerating proof-of-concept by use of xenograft models and experimental clinical studies)
  • Clinical testing: Phase 1 and QoL (including the dermatologist's perspective)
  • Innovation and methodology (imaging in clinical trials, objective assessment of itch and open flow perfusion for determination of in vivo penetration)
  • Pediatric development (a 2011 update on the EU and US regulatory requirements for pediatric development and the specific challenges for dermatological products)
  • Generics (a retrospective look five years after the introduction of the FDA guidance for topical corticosteroid bioequivalence testing)
  • Regulatory primer (navigating the regulatory pathways)
  • Regulatory round table discussion

For more program details and registration, please visit http://www.intercom-kongresse.de/secure/conreg_agah0411/registration/default.asp?varSessionID=615505567221114