Drug Development in the EU: Regulatory Standards, Support and New Approaches

6.0
RAC Credits
Virtual Programs Virtual Programs Europe Europe
Wednesday, 09 September 2020 (9:00 AM) - Thursday, 10 September 2020 (2:00 PM) Eastern Time (US & Canada)

Drug development is a multi-step process that involves a number of opportunities and requirements for interaction with regulatory authorities. Contact with regulators spans from the design and approval of clinical trials, use of scientific advice and other support programs during development, definition of potential orphan status and pediatric development, to specific aspects of advanced therapy products, different ways of gaining approval and postmarketing activities and commitments. Once a drug is approved, negotiations on reimbursement and pricing are necessary for effectively bringing it to market. 

This workshop will address the various regulatory steps, explain the role of the European regulator not only as being a gatekeeper but also as an enabler supporting successful development, marketing authorization and market access. Both established approaches and specific new ones provided by the European regulatory network will be presented and discussed based on anonymized examples and discussion of practical cases and questions contributed by workshop attendees.


Pricing Amounts & Deadlines

6/23/2020 -8/14/2020:  Early Bird $400.00 Member | $500.00 Nonmember

8/15/2020 – September 7, 2020:  Regular $600.00 Member | $500.00 Nonmember

 

Objectives 
Upon completion, participants will be able to:
  • choose a tailored way of interacting with EU regulators in order to receive support in drug development
  • define strategic goals for successful submission of a marketing authorization application and subsequent request for reimbursement of a drug intended for the European market
  • understand and describe the role of European National Competent Authorities and Committees at the EMA, including their impact on various stakeholders in healthcare


Click here to download the agenda

 

Speakers         




RAPS Online Workshop Experience

Join from anywhere to advance your continuing education goals and earn RAC credits. Secure and high-quality live online classroom experience. Interactive tools to foster collaboration. Peer-to-peer engagement and support from instructors.



Cancellation Policy: All cancellation requests must be submitted in writing to raps@raps.org. RAPS is unable to accept cancellations by phone. Please specify the name of the person registered and event title. Should you need to cancel your registration, you can apply your credit to any RAPS program for the next 12 months. Substitutions may be accepted with written approval from RAPS and must be submitted to raps@raps.org. RAPS will allow substitutions up to the first day of the event.


Stephany Evans
Meeting and Events Specialist
Regulatory Affairs Professionals Society® 
Tel: 301 770 2920, ext. 229
5635 Fishers Lane, Suite 400, Rockville, MD 20852 USA


 

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