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How to prepare for your meeting with Health Authorities

Oct 14 2014 8:00AM - Oct 15 2014 5:45PM | Hotel Novotel Paris Charenton 3-5 place des Marseillais 94227 Charenton Le Pont, Paris France

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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 

Anyone who is part of a delegation for an HA meeting. Normally, Regulatory Affairs departments lead the delegation, but depending on the topics to be discussed, representatives from the following disciplines may be required to join:

  • Clinical Research
  • Non-clinical disciplines
  • Drug Safety
  • Chemical-pharmaceutical disciplines
  • Medical Affairs
  • Statistics
  • Project Management

Learning Objectives 

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

  • Feel confident about managing HA meetings
  • Know when you should request a HA meeting
  • Be prepared when you are invited for a meeting
  • Be sure which questions you should and should not ask
  • Learn how to interact with HA counterparts
  • Understand how to best communicate the outcome of the HA interaction to your management and how to drive implementation
  • Participants will complete a knowledge check at the end of the course and will be provided withfeedback to ensure learning objectives are attained.

Hotel & Travel 

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

Hotel Novotel Paris Charenton
3-5 place des Marseillais
94227 Charenton Le Pont
FRANCE

Tel (+33)1/46766060
Fax (+33)1/49776800
E-mail H1549@accor.com
Website http://www.novotel.com/gb/hotel-1549-novotel-paris-charenton/index.shtml

at the rates of EUR 150.00 per room inclusive of breakfast and exclusive of VAT.
To make your reservation please use the hotel booking form.

Important: The room rate is available until 30 August 2014 or until the group block is sold-out, whichever comes first.

In case of cancellation: The room can be cancelled 43 hours prior arrival, after that the credit card will be charged for the 1st night.

The Hotel Novotel Paris Charenton is located 10 minutes from Gare de Lyon train station, the vibrant Bastille district & Bercy. The liberté metro station (line 8) opposite the hotel gives direct access to Paris's main attractions like Place de la Concorde, Eiffel Tower, Opéra, etc.

Contact Information 

Registration Questions
Phone.: +41 61 225 51 51
Fax: +41 61 225 51 52
Monday-Friday 8:00-17:00 CET
diaeurope@diaeurope.org

Agenda and Event Logistics
Migle Skadauskaite, Event Planner
Phone: +41 61 225 51 43
Fax: +41 61 225 51 52
migle.skadauskaite@diaeurope.org

 

 

Faculty 

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Agenda  

Day 1 Tuesday, Oct 14, 2014

  • 8:00AM - 9:00AM

    REGISTRATION
  • 9:00AM - 10:30AM

    Session 1: MEETINGS WITH HEALTH AUTHORITIES DURING PRODUCT DEVELOPMENT, MARKETING APPLICATION AND PRODUCT LIFECYCLE
  • 10:30AM - 11:00AM

    COFFEE BREAK
  • 11:00AM - 12:30PM

    Session 2: HEALTH AUTHORITIES’ ORGANISATIONAL STRUCTURE AND THEIR MAIN COMMITTEES
  • 12:30PM - 2:00PM

    LUNCH
  • 2:00PM - 3:30PM

    Session 3: TYPES OF INTERACTIONS / MEETINGS IN THE EU – SCIENTIFIC ADVICE - HEARINGS - EXAMPLES
  • 3:30PM - 4:00PM

    COFFEE BREAK
  • 4:00PM - 5:30PM

    Session 4: TYPES OF INTERACTIONS / MEETINGS US
  • 5:30PM - 6:30PM

    DRINKS RECEPTION

Day 2 Wednesday, Oct 15, 2014

  • 9:00AM - 10:30AM

    Session 5: APPLICATION FOR ADVICE AND PREPARATION FOR THE MEETING
  • 10:30AM - 11:00AM

    COFFEE BREAK
  • 11:00AM - 12:30PM

    Session 6: TYPES OF INTERACTIONS/MEETINGS IN EUROPE: EXAMPLES
  • 12:30PM - 2:00PM

    LUNCH
  • 2:00PM - 3:30PM

    Session 7: HEALTH AUTHORITY MEETING - ROLE PLAY AND DISCUSSION
  • 3:30PM - 4:00PM

    COFFEE BREAK
  • 4:00PM - 5:30PM

    Session 8: FOLLOW-UP ACTIONS OF MEETINGS DISCUSSION AND WRAP-UP
  • 5:30PM - 5:45PM

    COURSE ASSESSMENT

Registration Fees 

Member

Member Academia
€710.00
Member Government
€710.00
Member Standard
€1420.00

Non-Member

NonMember Academia
€840.00
NonMember Government
€840.00
NonMember Standard
€1550.00
Register Online

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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