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Essentials of European Regulatory Affairs

Nov 3 2014 8:30AM - Nov 4 2014 5:30PM | Hotel Novotel Paris Charenton 3-5 place des Marseillais 94227 Charenton Le Pont, Paris France

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Overview 

This is the must-attend training course for anyone needing to learn the essentials of European Regulatory Affairs - it has been extended to two days to include more topics, and it is kept up to date in minute detail by the experienced faculty.

The course will give an overview of the European regulatory system for human medicines, including the legislative processes and European Networks, the different routes for obtaining a licence for the European market, the centralised, the decentralised and the mutual recognition procedures, and the national procedures. In addition the specific European procedures for orphan drugs, paediatrics, advanced therapies and combination products will be discussed. This will cover the different steps and timelines in the different procedures, the clock-stops, the compiling of questions etc.  

An introduction regarding the lifecycle will be given by information in respect to pharmacovigilance, variations and renewals.

The course will cover the curernt registration systems available for approval of medicinal products:

  • Regulation EC726/2004 on the centralised procedure, including specific marketing authorisations and the European Medicines Agency
  • Directive 2001/83/EC the Community Code on the Mutual Recognition Procedures
  • Decentralised procedure and referrals

What the participants from previous courses say:
"The very well organized training course, at the high professional level."
"It helped a lot in understanding of European regulatory affairs as I have never worked with them before"
"I was pleased with attend to this course"

What You Will Learn 

  • The European Network
  • Marketing Authorisation for Medicinal products in the EU
  • Lifecycle Management

Who Should Attend 

Professionals in regulatory affairs, project management and product development.

Learning Objectives 

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

  • Explain the European Network and registration procedures
  • Describe the concepts of marketing authorisation and regulatory data protection
  • Discuss the key issues that impact the choice of the registration procedure
  • Describe the lifecycle management

Participants will complete a knowledge check at the end of the course and will be provided with feedback to ensure learning objectives are attained.

Hotel & Travel 

Course venue
Novotel Paris Charenton
3-5 place des Marseillais
94227 Charenton-le-Pont
France
Tel +33 1 46 76 60 60
Fax +33 1 49 77 68 00
E-mail H1549@accor.com
Website

To book the hotel room please contact the hotel directly for the availability and the best rate.
The Hotel Novotel Paris Charenton is located 10 minutes from Gare de Lyon train station. Take the Metro Line 1 towards Chateau de Vincennes or Metro Line 5 towards Marne-la-Vallee / Boissy-St-Leger and get off at Reuilly-Diderot (1 stop). Change to Metro Line 8 towards Pointe du Lac and get off at Liberte (6 stops). The hotel is located opposite of Metro station. For more information, please visit the hotel website.

Contact Information 

Registration Questions
DIA Europe, Middle East & Africa
Contact Center
Tel: +41 61 225 51 51
Fax: +41 61 225 51 52
Monday-Friday 08:00-17:00 CET
diaeurope@diaeurope.org

Agenda and Event Logistics
Gunta Sveke, Event Manager
Tel: +41 61 225 51 55
gunta.sveke@diaeurope.org

 

 

Faculty 

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Agenda  

Day 1 Monday, Nov 03, 2014

  • 8:00AM - 8:30AM (Central Europe Standard Time)

    REGISTRATION
  • 8:30AM - 10:00AM (Central Europe Standard Time)

    Session 1: EUROPEAN UNION – ROLE AND RESPONSIBILITIES OF EUROPEAN
  • 10:00AM - 10:30AM (Central Europe Standard Time)

    COFFEE BREAK
  • 10:30AM - 12:30PM (Central Europe Standard Time)

    Session 2: LIFECYCLE OF A MEDICINAL PRODUCT
  • 12:30PM - 1:30PM (Central Europe Standard Time)

    LUNCH
  • 1:30PM - 3:00PM (Central Europe Standard Time)

    Session 3: EU LICENSING PROCEDURES – PART I
  • 3:00PM - 3:30PM (Central Europe Standard Time)

    COFFEE BREAK
  • 3:30PM - 5:00PM (Central Europe Standard Time)

    Session 4: EU LICENSING PROCEDURES – PART II A
  • 5:00PM - 6:00PM (Central Europe Standard Time)

    DRINKS RECEPTION

Day 2 Tuesday, Nov 04, 2014

  • 8:30AM - 10:30AM (Central Europe Standard Time)

    Session 4 continued: EU LICENSING PROCEDURES – PART II B
  • 10:30AM - 11:00AM (Central Europe Standard Time)

    COFFEE BREAK
  • 11:00AM - 12:30PM (Central Europe Standard Time)

    Session 5: PHARMACOVIGILANCE
  • 12:30PM - 1:30PM (Central Europe Standard Time)

    LUNCH
  • 1:30PM - 2:30PM (Central Europe Standard Time)

    Session 6: VARIATIONS / POST APPROVAL CHANGES
  • 2:30PM - 2:45PM (Central Europe Standard Time)

    COFFEE BREAK
  • 2:45PM - 3:15PM (Central Europe Standard Time)

    Session 7: HARMONISATION & DEFINED MEDICINAL PRODUCTS
  • 3:15PM - 4:00PM (Central Europe Standard Time)

    Session 8: COMBINATION PRODUCTS
  • 4:00PM - 4:30PM (Central Europe Standard Time)

    COURSE ASSESSMENT

Registration Fees 

Member

Charitable Nonprofit/Academia Member
€710.00
Member Government
€710.00
Member Standard
€1420.00

Non-Member

Charitable Nonprofit/Academia Nonmember
€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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