Bioequivalence and Bioavailability Forum

Dear all,

a personal recommendation (last year in Lisbon was a great event):

2^nd CMD(h)-EGA SYMPOSIUM ON BIOEQUIVALENCE
"Bioequivalence guideline revision, Regulatory procedures and Good Practices:
paving the way towards an even more efficient regulatory framework"

Organised in conjunction with the CMD(h), this 2^nd joint symposium gathers Members of CMD(h), European Assessors (Members of the EWP), Members of the European Inspectorate, as well as of the European Generics Medicines Association.

This symposium represents one in a series of initiatives being taken by the EGA in conjunction with EU authorities to help improve the efficiency and working of the EU approval system. Last year's event gathered over 80 representatives of generic pharmaceutical companies and over 50 representatives from agencies and academia.

It will focus on key European developments relating to bioequivalence:

• Data Integrity and GCP/GLP inspections
  
• Outcome of the revision of the bioequivalence guideline
  
• Early and late Dialogue with authorities, from Scientific Advice to Referrals
  
• Guidance for the development of locally acting products (dermatological and ophtalmic preparations)

Speakers will include experts from the regulatory authorities, including CMD(h) and EMEA experts, as well as experts from the generic medicines industry.

FULL PROGRAMME
Registrations are open for EGA Members only. On the 1 September 2008 will open for Non-members and they will close on the 1 October 2008 on www.gpaconferences.com/ega.htm
Due to a limited number of places preference will be given to EGA Members and registrations will be subject to availability.