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How to manage a successful health authority interaction

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Date: 14-Oct-15 to 15-Oct-15
Location: Holiday Inn London Kensington / London / United Kingdom
Category: Education Healthcare & Pharmaceuticals Conferences & Trade Fairs

Health Authority (HA) meetings with the major HAs (ICH region) are an essential part of drug development. Each pharmaceutical company will sooner or later be faced with such meetings. This important course covers HA meetings in the EU and in the US.

This course is a hands-on course full of practical work. It is necessary that you bring your laptop with you.

What participants from previous courses say:
“Presentation content was very good, detailed and interactive. Case studies were very helpful”
“Phrasing of questions for SA and selection of the best SA procedure (EMA vs. national) was quite useful for me”
“I appreciated the sharing of experience and concrete examples from the instructors and engagement for the audience to share their own experience”
“A very enjoyable learning experience. I have gained more in-depth knowledge which I can take back and share with my team. All abstracts were excellent”

What You Will Learn
Different kinds of HA meetings in the EU and in the US
How to prepare for HA meetings
The questions to ask
How to get the most out of HA meetings
How to negotiate

Hot Topics will also be covered, e.g. latest updates on FDA and EMA guidances and procedures like:
Draft FDA Guidance on Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products
Guidance for Industry on Critical Path Innovation Meetings
EU Adaptive Licensing Pilot Project
Best Practice guidance for Pilot EMA HTA Parallel Scientific Advice procedures and HTA Network meetings

Who should attend
Professionals likely to be part of a delegation for an HA meeting. Usually, Regulatory Affairsand other specialists may be invited, e.g.
Clinical Research Professionals
Medical Affairs Professionals
Statisticians
Drug Safety / Pharmacovigilance Professionals
Non-clinical disciplines
Chemical-pharmaceutical disciplines
Project Manager

Exhibitors

Gabriele Disselhoff, Truus Janse-de Hoog, Otmar Pfaff

Go to event website