|Scientific Program||Registration and Abstract submission||Venue, Hotel and Travel Information||Committees and Contact
Scope & Aim
An EMA/CHMP Draft guideline on quality and equivalence of topical products 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” based on comments submitted to the organisers in the run-up phase to the event. All participants are invited to present their views and suggestions, based on their own experience, during the discussion and support these proposals by experimental data. Written feedback will be given to the regulators by the deadline based on a collective summary of the discussion points.
The Open Discussion Forum will open on Wednesday, June 12, 2019 at 09:15 and close on Thursday, June 13, 2019, at 16:30.
Who should attend?
This Open Discussion Forum is designed to meet the requirements and expectations of professionals from the generic and the research based industry, CROs, academia and regulatory agencies. Department heads, project managers, scientists and consultants in R&D, in formulation development, in regulatory affairs, pharmacokinetics, clinical operations, biostatistics and so forth should attend in order to contribute their experience in an exchange with the scientists from European regulatory agencies. All delegates are invited to contribute actively to the scientific discussions and to support the process towards science driven regulations.