This webinar will describe the possibilities offered by regulators for discussion and when they can best be used. It will also expand on the information required by regulators in preparation for and during interactions.
Engagement through a regulatory advice meeting with health authorities is a key stage in the development of any drug. The frequency of the engagement and extent to which the regulators will be involved varies significantly from compound to compound.
Much of the advice being offered by the European Medicines Agency (EMA) and national agencies is focused on helping companies, particularly small to medium enterprises (SMEs), to prepare their medicines properly for clinical trials, by validating their non-clinical and early clinical strategy. However, quality aspects and the manufacturing process also warrant discussion early in the development process.
This is particularly true for a rising number of leading edge innovations categorized as advanced therapy medicinal products (ATMPs), made from tissues, genes, or cells, which may offer ground-breaking new treatment opportunities for many conditions.
This webinar will describe the possibilities offered by regulators for discussion and when they can best be used. It will also expand on the information required by regulators in preparation for and during interactions. A practical case study will illustrate, from an industry perspective, how these are best used and how they can be implemented in your strategy.
Key Learning Objectives
- Discover the possibilities regulators offer
- Learn when interaction with regulators in early phase development can be helpful
- Understand which information regulators require to be included in the briefing package
Who Should Attend
- Head of R&D
- Head of Regulatory Affairs
- Clinical Pharmacology & PK/PD Modeling Managers
- Clinical Research Managers
- Project Managers
- Bruno Speder, Head Clinical Regulatory Affairs & Consultancy, SGS, Life Sciences – Clinical Research
- Dr. Alex Kudrin, MD, PhD, MBA, Independent Biopharmaceutical Consultant
Session 1 – Europe
March 29, 2018, at 3pm CEST (2pm BST)
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Session 2 – North America
April 17, 2018, at 11am EDT (10am CDT, 8am PDT)
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