Scientific Advice with Regulators – An Essential Tool in Early Drug Development

Mar 29, 2018

Register Free: http://www.appliedclinicaltrialsonline.com/act_w/regulators

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 webcast 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.

 

The Webcast will Address:

  • Understand the possibilities for discussion 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

 

Speakers:

Bruno Speder, Head Clinical Regulatory Affairs & Consultancy, SGS, Life Sciences

 

Date and Time:

Europe Live: Thursday, 29 March, 2018 at 1500 CEST | 1400 BST

After the final airing of the webcast on 29 March, 2018 it will be available on demand until 29 March, 2019. 

Sponsor: SGS Life Sciences

Register Free: http://www.appliedclinicaltrialsonline.com/act_w/regulators

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