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Benefit/Risk Management (description)

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Category:Healthcare
Address:Dorint an der Messe, Schoenaustrasse 10, Basel, , Switzerland 4058
Phone:+41 61 225 51 51
Event dates:11/21/2016 - 11/22/2016 (This event has already taken place)
Event web site:http://go.evvnt.com/71323-0
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Speakers/Presenters:

Topics to be Covered:

  • Science, Health and Medicine
  • Pharmaceuticals
Contact:daniel.hartman@diaglobal.org
Organizer phone:+41 61 225 51 51
Offering type:Conference
Specialty:Data not provided
Event frequency:Never
First Meeting:
Total events:
Est. attendance:
Target audience:Any
Other target audiences:
Host Sponsor:DIA
Est. # of exhibitors:
Currency:Euro
Language:English
CE Credits:
Organizer URL

Description:

This intensive course explores current opportunities made possible by the new legislation, advances in information technology and a new scientific methodology to enhance and modernise the approaches in the product lifecycle management.

The course starts with the current regulatory thinking about the benefit/risk methodology, including the relevant project of the European Medicines Agency (EMA) / Committee for Medicinal Products for Human Use (CHMP). It gives a basis for the second part of the course, exploring the new European benefit/risk management planning - a notion stemming from the experience gathered over five years with the EU Risk Management Plans (EU-RMPs). Participants will learn how to take advantage of the efficacy follow-up options given by both the European Paediatric Regulation and the Advanced Therapies Regulation. A practical training in drafting key aspects of the regulatory submissions is included.

Although a lot of things may be planned and controlled, there are always unforeseen scenarios. The last part of the course will help participants to deal with the most dangerous ones - when the benefit/risk of the product is suddenly affected by emerging information. Participants will be trained on how to deal with such a situation, using the most effective techniques in risk communication and media crisis management.

What you will learn

- New legal possibilities for benefit optimisation and risk minimisation of products in the EU
- Designing benefit/risk management systems using current regulatory tools, including: EU Risk Management Plans (EU-RMPs), Risk Evaluation and Mitigation Strategies (REMS), Development Safety Update Report (DSUR), Periodic Safety Update Report (PSUR), Follow-Up Measures (FUMs), and potentially EU Benefit Risk Management Plan (EU-BRMP)
- Choice of effectiveness of study design for safety and efficacy follow-up
- How to manage a media, legal and regulatory crisis

Schedule:

Time: 8:00 am - 3:15 pm

Registration Fee Details:

Standard: EUR 1605

Other items that tuition includes:

Travel and hotel arrangements:

 
 
Contact Person:Daniel Hartman
Contact Emaildaniel.hartman@diaglobal.org
Organizer Address 1Kuchengasse 16
Organizer CityBasel
Organizer State/Province: (Outside US)
Organizer Zip or Postal Code4051
Organizer CountrySwitzerland
Organizer Phone+41 61 225 51 51
Structural makeupOrganization
Host Sponsor; Other SponsorsDIA
Event sold out?No
Multiple locations or dates?No
Statistics available for most recent event held in:NA
Average number in event attendance of:
Range:
Number in attendance of:
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Target BoundariesInternational
Is Registration contact information the same as Organizer Contact above?Yes
Web Page
Can one register for your CE on your web site?NA
Can registration be made by snail (regular) mail?Yes
Online housing reservations: 
 
Do you have additional written or AV materials for sale?No
If so, are they available for non-attendees as well as those attending?NA
Is full tuition necessary to ensure registration?No
Will there be shuttle service available?NA

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