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3R Pharma’s Manuel Zahn to Chair London Stability Conference
Dobel, Germany: –Dr. Manuel Zahn, founder of pharmaceutical regulatory advisers, 3R Pharma Consulting, will chair the 2014 Informa Life Science Conference on Stability Testing for Pharmaceuticals in London this month.
The conference, on March 18 and 19, will examine a series of key current issues for life sciences stability testers and laboratories, including new MHRA variation classifications, different climates, different regimes in Far Eastern and Latin American markets, solid state physical form changes, examining drugs in suspension and outsourcing.
Dr. Zahn will also lead a pre-conference workshop on Monday, March 17: ‘Practically Managing Temperature Excursions and Using Stability Data to Support Shelf-Life during Shipping and Transport’.
The all-day session will examine detailed issues of managing temperature fluctuations (excursions), humidity and physical movement, using stability data more effectively to enhance shelf life of substances in transit, regulatory requirements for temperature monitoring during shipping and storage and the limitations of the Mean Kinetic Temperature (MKT) concept.
Dr. Zahn has been closely associated with the Stability Testing for Pharmaceuticals event since the very beginning.
“I chaired the first ibc (now Informa)Stability Testing conference in 1994 and have been honoured to contribute as speaker and chairman every year since,” said Dr. Zahn.
“This is a very valuable event in furthering industry understanding on shared challenges like understanding how to maintain compliance with increasing regulatory expectations, how to reach faster and more reliable decisions on optimized formulations and adequate packaging and how to reduce cost and time spent on stability testing,” he added.
About 3R Pharma Consulting
3R Pharma Consulting supports pharma companies in achieving their goals in all phases of pharmaceutical development (pre-approval) as well as maintenance of marketed products (post-approval). 3R Pharma Consulting’s extensive experience and competence in Regulatory Sciences, Chemistry, Manufacturing and Control (CMC) / Quality allow to effectively reduce the risk of failure or delay.
About Informa Life Science Conference on Stability Testing in Pharmaceuticals
The Informa Life Sciences hosted conference ‘Stability Testing in Pharmaceuticals’ will take place on March 18-19 at the Barbican in London.
The conference aims to gather experts working in life sciences stability, analytical, quality, API and research disciplines to examine detailed issues on stability testing and management.
Key areas of discussion will focus on the latest advances in stability validation and management, including:
• Implications of new MHRA variation classifications
• impact of different climatic zones on stability protocols and shelf-life
• variations between ICH regulatory requirements and those in emerging markets, such as China, Brazil and Mexico
• extracting teachable lessons from stability studies
• understanding physical form changes in testing
• specific issues for drugs in suspension
• outsourcing of stability studies
Apart from Dr Zahn, there will be almost 20 speakers, including Carla Landolfi, Head of Toxicology and Preclinical Development at Angelini, Dave Elder, Director, of SCINOVO at GlaxoSmithKline Pharmaceuticals, GülcanBenzer, Stability Head at Abdi Ibrahim Pharmaceuticals, Suzanne Thiilborg, Head of Analytical Development Product at H. Lundbeck A/S and Mohamed Oubihi, Managing Director of YAKUMED.
Dr. Manuel Zahn, Managing Director, 3R Pharma Consulting GmbH
Tel: +49 (0) 7083 527 6870