Communicating with EU Regulators/Health Authorities: An Overview of Approach, Planning and Procedure – Webinar
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|---|---|---|---|---|
| No sessions are planned at this time, however if you are interested in taking this course click here | ||||
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About this course
Reasons to attend
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 – Suggesting that the chances of regulatory approval are doubled if communicated effectively, and hence, receive the right advice from the European Medicines Agency (EMA)/CHMP.What's included?
- Documents and materials related to this course are included
- Globally recognised certificates awarded after test completion
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.1Programme highlight
- 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
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)
Who should attend
- 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.
Competencies
This course covers competencies that are part of the ECCRT Competency Framework
- Scientific Concepts & Research Design ()
- Ethical & Participants Safety Considerations ()
- Investigational Product Development and Regulation (3)
- Clinical Studies Operations (GCPs or ISO 14155) ()
- Study and Site Management ()
- Data Management and Informatics ()
- Leadership and Professionalism ()
- Communication ()
- Teamwork ()
- Business acumen ()
Trainers
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