EUFEPS Open Discussion Forum 2019

Openforum19EUFEPS announces the 2019 Open Discussion Forum to be held in Bonn, Germany between June 12-13, 2019 in collaboration with the EUFEPS Network on Dermatopharmacy. 
Revised European Guideline on quality and equivalence of topical products June 12-13, 2019 | Bonn, Germany

EUFEPS announces the 2019 Open Discussion Forum to be held in Bonn, Germany between June 12-13, 2019 in collaboration with the EUFEPS Network on Dermatopharmacy.

This meeting will be focused on the EMA/CHMP Draft guideline on quality and equivalence of topical products which has been released for consultation in December 2018. The scientific community is now invited to submit comments to the suggested regulations by June 30, 2019. There are a number of significant aspects in this guideline which require intense scientific discussion.

Relevant questions are, amongst others, summarised in the following

  • When is a waiver of any human in vivo study based on formulation and quality characterisation possible?
  • For which formulations/active substances are solely in-vitro skin permeation studies adequate?
  • Which surrogate in vivo pharmacokinetic or pharmacodynamic studies are acceptable to substitute for clinical endpoint efficacy (and safety) trials in regard to the site of action. What are the validation requirements for such pharmacokinetic or pharmacodynamic studies?

The intention of this gathering is to give scientists from industry and academia the opportunity to discuss the new regulations with representatives from regulatory authorities in Europe. It will be organised as an “Open Discussion Forum”. All participants are invited to present their views and suggestions, based on own experience, during the discussion and support these proposals by experimental data.

A summary of the relevant comments will then be submitted to authorities for a conclusive commenting of the guideline.

Session topics include:

·         Quality Assessment of topical products - in vitro testing procedures

·         Surrogate pharmacokinetic studies: validation and standardisation - opportunities and limitations

·         Ex-vivo and in-vivo pharmacodynamic studies: adequate tools for assessing equivalence?

The registration fees include: 
• Attendance of the Scientific Program
• Congress material
• Certificate of attendance
• Dinner on June 12, 2019
• Light Lunches and Coffee Breaks

Venue:

Hilton Hotel Bonn

Berliner Freiheit 2,

53111 Bonn

Symposium website

Registration is now open: Register now!

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