Health Authority Interactions - Preperation, consultation and implementation

Oct 15 2013 8:00AM - Oct 16 2013 5:00PM | Hotel Mgallery Am Konzerthaus Am Heumarkt 35-37 1030 Vienna Austria

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Overview

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.

Key Topics

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

Who Should Attend

This training course is aimed at professionals in:

Regulatory Affairs
Research & Development
Project Management
Clinical Research
Non-clinical disciplines
Chemical-pharmaceutical disciplines

Level: Intermediate

Learning Objectives

At the conclusion of this course, participants should be able to:

Determine when they should request HA meetings
Determine which questions they should and should not ask
Recognise when questions to different HAs should vary
Apply the right kind of negotiation skills with HA counterparts
Understand how best to communicate the outcome of the HA interaction to their management and how to drive implementation

Hotel & Travel

The DIA has blocked a limited number of rooms at the following hotel:

Hotel MGallery am Konzerthaus
Am Heumarkt 35-37
1030 - VIENNA
AUSTRIA
Email: H1276@accor.com
Tel: (+43)1/716160
Fax: (+43)1/71616844

at the rate of:
EUR 147.00 per room inclusive of breakfast, service and VAT.

To make your reservation please use this booking form

Important: Please complete your reservation by 16 September 2013. Reservations received after this date will be subject to hotel availability and room rate may vary.

Cancellation free of charge is possible until 72 hours prior arrival. If you cancel your booking too late or in case of No Show, 100 % will be charge from your credit card.

Contact Information

DIA Europe

KUECHENGASSE 16, POSTFACH

4002 BASEL

SWITZERLAND

TEL.: +41 61 225 51 51

FAX: +41 61 225 51 52

E-MAIL: DIAEUROPE@DIAEUROPE.ORG

Faculty

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Gabriele Disselhoff, PhD

Managing Director
Creative Regulatory & Quality Solutions (CRQS), Germany

Stefan Schwoch, PhD,RPh

Senior Director, Global Regulatory Affairs – EU, Oncology and Cardiovascular
Eli Lilly, United Kingdom

Truus Janse-de Hoog, PharmD,MSc

Staff Member European cluster
Medicines Evaluation Board, Netherlands

Registration Fees

Member

Member Academia: €683.00
Member Government: €683.00
Member Standard: €1365.00

Non-Member

NonMember Academia: €798.00
NonMember Government: €798.00
NonMember Standard: €1480.00

CANCELLATION POLICY: All cancellations must be made in writing and received at the DIA office five working days prior to the event start date. Full event cancellations are subject to an administrative fee:

Industry (Member/Non-member) = €200.00
Academia/Charitable/Government /Non-profit (Full-Time) (Member/Non-member) = €100.00
Tutorial cancellation: €50.00

If you do not cancel five working days prior to the event start date and do not attend, you will be responsible for the full registration fee. DIA reserves the right to alter the venue and dates if necessary. If an event is cancelled DIA is not responsible for airfare, hotel or other costs incurred by registered attendees. Registered attendees are responsible for cancelling their own hotel and travel reservations.

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