NH Berlin Alexanderplatz, Berlin, Germany
May 9 2012 9:00AM - May 10 2012 4:00PM
Local tolerance testing for investigational topical drug products is a key element during both non-clinical
and clinical safety evaluations. However, scientific knowledge and regulatory expectations appear to be
fragmented. This workshop provides a unique opportunity to share best practices among the industry
and – even more importantly – to discuss them with feedback from regulatory and academic experts. In
addition, understanding different perspectives and elaborating on potential consensus positions may well
facilitate the preparation of new regulatory guidance documents during the next years.
Learning Objectives:
• Identify best practices to test for local tolerance of topical drugs and highlight potential limitations or
typical concerns
• Describe options and strategies, how to integrate non-clinical local tolerance testing into general drug
development programmes
• Assess the value of non-clinical vs clinical approaches
• Outline a potential consensus position among industry and regulatory authorities Event Code:
12121
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Invited Speakers:
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Programme Chair Daniel M. Bauer Senior Investigator, Preclinical Safety, Novartis, Switzerland Programme Committee Abigail Jacobs, Associate Director for Pharmacology and Toxicology, CDER, FDA, USA David R. Jones Expert Pharmaco-Toxicologist, Licensing Division, MHRA, UK Alexandre Kaoukhov Senior Clinical Development Director, Allergan, USA Marc Princivalle Director of Toxicology, Preclinical Safety Assessment, Stiefel – a GSK Company, UK
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