Regulatory course
Communicating with EU Regulators/Health Authorities: An Overview of Approach, Planning and Procedure
In an article by Matthias Hofer1 the authors note that during the period 2008 – 2012, 85% of applications compliant with ‘communications’ (scientific advice) were approved, whereas only 41% of non-compliant applications were approved –…
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Who it’s for
Is this course for you?
- Anyone involved in EU Agency/Heath Authority interactions, the preparation, hosting, or responses, including: R&D, Manufacture and Regulatory Affairs.
- Directors/Managers can enhance the Regulatory knowledge/performance by inviting R&D, Manufacture and Regulatory Affairs personnel to this learning experience. They will gain a significant appreciation of the strategies behind effective communication with the EU Regulators, and they will learn the critical approaches required in order to prepare for a successful/positive outcome.
What you’ll learn
About this course.
Course Description
During this webinar, the strategy behind effective communication with the EU Regulators will be discussed and shall provide a useful overview of how to Approach, Plan and use the Procedure to gain a successful outcome.1
Learning objectives
- What Tools are available to Communicate with the Regulator/Health Authorities
- Have an insight into the Strategy behind communicating when considering ‘’Scientific Advice’’
- Identify what are the differences and similarities behind EMA (CHMP) Vs National Advice
- You should be able to Explain the Basic Approach to EU National / Local Scientific Advice
- Identify when to Seek and Explain the EMA (CHMP) Advice Procedure
- Explain the scope of EMA Parallel scientific advice with the US-FDA
- You should be able to provide an Overview of Parallel Health Technology Assessments (HTA)
1 “Impact of scientific advice from the European Medicines Agency” by Matthias Hofer, et. al. (Nature Reviews, Drug Discovery Volume, 14, May 2015, pp303).
Programme highlights
- Initial Thoughts to Consider: Tools to Communicate with the Regulator/Health Authorities
- Strategy behind communicating: Focal Point on ‘’Scientific Advice’’
- EMA (CHMP) Vs National Advice
- EU National / Local Scientific Advice
- EMA (CHMP) Advice Procedure
- EMA Parallel scientific advice with the US-FDA
- An Overview of Parallel Health Technology Assessments (HTA)
- Case Studies / Q&A
Competencies
What this course builds.
How many competencies of the ECCRT Competency Framework this course covers, by area.
- Investigational Product Development and Regulation3
Good to know
Questions about this course.
Can I book for several colleagues?
Yes. Choose the number of participants next to a date. For a group of 4 or more, an in-house session tailored to your SOPs may suit you better.
What if I need to cancel?
Cancelling more than 30 calendar days before the course is free of charge. Between 21 and 30 days before, 50% of the fee is due, and the full fee within 21 days. A €50 administration fee applies per cancellation. You can also send a colleague in your place by letting us know in writing.