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DIA Training Course on
How to prepare for your meeting with Health
Authorities and present your product
Health Authority Interactions – Preparation, presentation and
implementation
Course #14546
14-15 October 2014
Novotel Paris Charenton, France
Faculty
Gabriele Disselhoff
Managing Director
Creative Regulatory & Quality Solutions (CRQS),
Germany
Truus Janse-de Hoog
Former Staff Member European cluster
Medicines Evaluation Board, the Netherlands
Stefan Schwoch
Senior Director, Global Regulatory Affairs –EU, Oncology and Cardiovascular
Eli Lilly, UK
Overview
If you work in pharmaceutical industry, you will sooner or later be faced with health authority meetings,
be it during product development, during the application for a marketing authorization or later in the
lifecycle of your drug to discuss pharmacovigilance matters.
This important course covers Health Authority (HA) meetings (and other interactions) in the EU and the
US. You will learn by performing role plays yourself and by many case studies.
Key Topics
• Different kinds of HA meetings in the EU and in the US
•How to prepare for HA meetings
•How to compose the best team for a meeting
•How to present your case and get the most out of your meeting
•The questions to ask - and not to ask
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
•Apply the right kind of negotiation skills 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 with
feedback to ensure learning objectives are attained.
Who Will Attend
You – if you are part of a delegation for an HA meeting. Normally, Regulatory Affairs departments lead
the delegation, but depending on the topics to be discussed, this can be:
Continuing Education
•Clinical Research
•Non-clinical disciplines
•Drug Safety
•Chemical-pharmaceutical disciplines
•Medical Affairs
•Statistics
•Project Management
•Pharmacovigilance experts
DIA meetings and training courses are generally
approved by the Commission for Professional
Development (CPD) of the Swiss Association
of Pharmaceutical Professionals (SwAPP) and
the Swiss Society of Pharmaceutical Medicine
(SGPM) and will be honoured with credits for
pharmaceutical medicine. All participants are
eligible for these credits.
This course has limited capacity.
Register early.
PharmaTrain recognised
2
DAY 1
DAY 2
08:00 REGISTRATION
09:00 Session 1
09:00 Session 5
APPLICATION FOR ADVICE AND PREPARATION FOR THE MEETING
Considerations for meeting requests, application forms, submission
of meeting requests form part of this Session, in addition the Briefing
Book itself with key considerations, which questions to ask and
differences between EU and US.
MEETINGS WITH HEALTH AUTHORITIES DURING PRODUCT
DEVELOPMENT, MARKETING APPLICATION AND PRODUCT
LIFECYCLE
The different opportunities for Health Authority Interactions in the EU
and the US during drug development are discussed.
Group work
Group work
10:30 COFFEE BREAK
10:30 COFFEE BREAK
11:00 Session 6
11:00 Session 2
HEALTH AUTHORITIES’ ORGANISATIONAL STRUCTURE AND THEIR
MAIN COMMITTEES
EU Regulatory network and system, Committees and Working Parties
and their interactions are explained as well as the organization of FDA
and US Advisory Committees.
12:30 Group work
LUNCH
14:00 Session 3
TYPES OF INTERACTIONS/MEETINGS IN EUROPE: EXAMPLES
Examples presented in this Session are joint EMA – HTA advice, advice
for orphan drug applications, qualification of Novel Methodologies,
Innovation Task Force, protocol assistance.
Group work
12:30 LUNCH
14:00 Session 7
HEALT AUTHORITY MEETING - ROLE PLAY AND DISCUSSION
Central part of this Session are the role plays, in which participants
get the opportunity to prove their negotiation skills either as health
authority side or industry.
After the role plays, Dos and Don’ts of meetings will be discussed and
information on other types of interactions given
TYPES OF INTERACTIONS/MEETINGS IN THE EU: SCIENTIFIC
ADVICE – HEARINGS - EXAMPLES
Emphasis of this Session is Scientific Advice in Europe. This includes
questions like whether to go for advice and where to go, i.e. decision
between CHMP or national advice, or which Member State to choose.
Group work
Group work
15:30 COFFEE BREAK
15:30 COFFEE BREAK
16:00 Session 8
16:00 Session 4
TYPES OF INTERACTIONS/MEETINGS IN THE US
Different types of meetings with FDA are dealt with, as well as
parallel advice between CHMP and FDA, comparison of presubmission
meetings, PDUFA update .
FDA representative via Webinar invited
Group work
17:30 DRINKS RECEPTION
18:30 END OF DAY ONE
FOLLOW-UP ACTIONS OF MEETINGS DISCUSSION AND WRAP-UP
Participants will learn what needs to be done after a meeting, on the
one hand towards the health authority and on the other hand within
the company.
17:30 END OF TRAINING COURSE
About DIA
DIA is the global connector in the life sciences product development
process. Our association of more than 18,000 members builds productive relationships by bringing together regulators, innovators, and
influencers to exchange knowledge and collaborate in an impartial
setting. DIA’s network creates unparalleled opportunities for exchange of knowledge and has the inter-disciplinary experience to
prepare for future developments.
The dedicated efforts of DIA staff, members and speakers enable DIA
to provide a comprehensive catalogue of conferences, workshops,
training courses, scientific publications and educational materials.
DIA is a global community representing thousands of stakeholders
working together to bring safe and effective products to patients.
Unless otherwise disclosed, DIA Europe acknowledges that the statements made
by speakers are their own opinion and not necessarily that of the organisation they
represent, or that of the DIA Europe. Speakers and agenda are subject to change without
notice. Recording during DIA Europe sessions is strictly prohibited without prior written
consent from DIA Europe.
DIA is an independent, non-profit organisation headquartered in
Washington, DC, USA with the European office in Basel, Switzerland,
and additional regional offices in Horsham, Pennsylvania, USA; Tokyo,
Japan; Mumbai, India; and Beijing, China.
For more information, visit www.diahome.org or call DIA Europe +41
61 225 51 51.
3
•
“Presentation content was very good + detailed + interactive. Case studies
were very helpful.”
•
“Case studies and role play were the most interesting part.”
•
“Phrasing of questions for SA and selection of the best SA procedure (EMA
vs. national) was quite useful for me. I found the role play interesting and
learning but more time and information on the cases would have been
helpful.”
HOTEL INFORMATION
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
•
“I thought the syllabus was good and the handouts were very important.”
Tel (+33)1/46766060
Fax (+33)1/49776800
E-mail [email protected]
•
“Role plays very useful and more memorable; extended slides have less
impact for me.”
Website
http://www.novotel.com/gb/hotel-1549-novotel-paris-charenton/index.shtml
•
“I appreciated the sharing of experience and concrete examples from
the instructors and engagement for the audience to share their own
experience.”
•
“I thought they (instructors) were all very knowledgeable and approachable.
Shared important information.”
•
“Varied backgrounds and great breadth of experience”
•
“A very enjoyable learning experience. I have gained more in depth
knowledge to which I can take back + share with my team. All abstracts were
excellent.”
•
“Why this course -> because I never go yet to meet EU agencies and I am
supposed to go next year.”
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 available on the
DIA website.
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.
DIA EUROPE, MIDDLE EAST & AFRICA CONFERENCES & WORKSHOPS 2014
 Achieving Improved Regulatory Efficiency within the current Framework:
Lessons from the Escher Project – jointly organised by DIA and TOPRA
18 September 2014 | Brussels, Belgium
 8th Annual European Medical Information and Communication Conference
and Exhibition
23-24 September 2014 | London, United Kingdom | ID 14103
 Clinical Trials Workshop I − Translating the New Clinical Trials Regulation into
Practice
23-24 September 2014 | London, United Kingdom | ID 14111
 Clinical Trials Workshop II − Translating the New Transparency Requirements
into Practice
24-25 September 2014 | London, United Kingdom | ID 14116
 Joint DIA/FIP European Workshop Biorelevant Performance Testing of Orally
Administered Dosage Forms
24-25 September 2014 | Amsterdam, the Netherlands | ID14109
 EFGCP/DIA/EMA Annual Conference on Better Medicines for Children – Exploring
ways to enhance collaboration between key players
30 September – 1 October 2014, EMA Headquarters, London, United Kingdom
 Joint DIA/ICOS Conference on Cardiac Toxicity Resulting from Cancer Chemotherapy:
Strategies for Early Detection, Risk Mitigation and Clinical Prevention and Exhibition
9-10 October 2014 | Prague, Czech Republic | ID14108
 4th African Regulatory Conference and Exhibition
22-23 October 2014 | Dakar, Senegal | ID 14105
 Workshop on HTA and Access to Medicines Status and Future
End October 2014 | location to be confirmed | ID14102
Joint DIA/AEMPS Statistics Workshop
10-11 November 2014 | Barcelona, Spain | ID 14107
 Maghreb Regulatory Conference and Exhibition
November 2014 | Algiers, Algeria | ID 14113
ISPE/DIA Workshop on Computer Science Compliance “Maintain Data Integrity to
Reduce Risk for the Patient”
6-7 November 2014 | Basel, Switzerland | ID 14112
 15th Conference on European Electronic Document Management (eDM) and Exhibition
1-3 December 2014 | Berlin, Germany | ID 14110
 Biosimilars Conference
2-3 December 2014 | Berlin, Germany | ID 14115
 27th Annual EuroMeeting and Exhibition
13-15 April 2015 | Paris, France | ID 15101
 8th Annual Clinical Forum and Exhibition
14-15 April 2015 | Paris, France | ID 15103
For more information and a complete listing of all DIA conferences and training courses, please visit:
www.diahome.org > click on Meetings & Training
Call DIA Europe on +41 61 225 51 51 or email: [email protected]
REGISTRATION FORM
How to prepare for your meeting with Health Authorities and present your product
14-15 October 2014, Novotel Paris Charenton , France
ID #14554
FEES
Member Non-Member
Industry
€1’420.00 
€1’550.00 
Academia/Charitable/Government/Non-profit (Full-time)
€
€ 840.00 
710.00 
Join DIA now to qualify for the member rate €130.00
If DIA cannot verify your membership upon receipt of registration form, you will be charged
the non-member fee.
*All fees are subject to French VAT at 20%.
Please advise your French VAT number:__________________
Group discount/SME rates available. Special rates for students and patient representatives on
offer, subject to avaibility – please contact DIA Europe for more information.
Registration fee includes: refreshments, lunches and training course material.
TOTAL AMOUNT DUE:
Payment is due 30 days after registration and must be paid in full by commencement of the course.
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Cancellation Policy
All cancellations must be made in writing and be received at the DIA Europe office five working days prior to the event start date. 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 Europe reserves the right to alter the venue and
dates if necessary. If an event is cancelled or postponed, DIA Europe 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.
Transfer Policy
You may transfer your registration to a colleague prior to the start of the event but membership is not transferable. Substitute attendees will be responsible for the non-member fee, if
applicable. Please notify the DIA Europe office of any such substitutions as soon as possible.
Photography Policy
By attending the event, you give permission for images of you, captured during the conference through video, photo, and/or digital camera, to be used by DIA Europe in promotional materials,
publications, and website and waive any and all rights including but not limited to compensation or ownership.
The DIA Europe Customer Services Team will be pleased to assist you with your registration from Monday to Friday between 08:00 and 17:00 CET.
Email [email protected]
Tel. +41 61 225 51 51
Fax +41 61 225 51 52
Web www.diaeurope.org
Mail DIA Europe, Kuechengasse 16, 4051 Basel, Switzerland© DIA 2014