SOMERSET, N.J. October 11, 2018
Catalent Pharma Solutions, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, today announced that three of its clinical supply experts will present workshops at two upcoming conferences.
Mr. Leo Zhang, Quality Director, Clinical Supply Services, Asia Pacific, Catalent, will present at the International Society for Pharmaceutical Engineering (ISPE) conference, to be held at the Nanjing International Expo Center, Nanjing, China, on Oct. 16 – 18, 2018. Mr. Zhang’s presentation, on Wednesday Oct. 17, is entitled “Chinese Good Manufacturing Practice (GMP) Regulation of Clinical Trial Materials: Practice in Real Life by Catalent,” and comes as the Chinese pharmaceutical industry assesses how the adoption of ICH global GMP standards and recent reorganization of the China FDA will impact clinical supplies.
In his presentation, Mr. Zhang will give an overview of the regulations governing GMP in China, explaining how they compare to Europe, before discussing the implementation of quality management systems, using case studies from Catalent. He will discuss issues including quality management, equipment, material control, documentation, production and shipment.
Catalent experts will also take part in two workshops at the Global Clinical Supplies Group (GCSG) 2018 European Knowledge Forum, at the Crowne Plaza Barcelona, Spain, from Oct. 23 – 25, 2018. Ms. Anne Flanagan, Senior Clinical Supplies Manager, Catalent, will lead the first workshop, discussing strategies for small companies to manage their supply chains. In the second workshop, Mr. Paul Byrne, Regional Operations Manager, APAC, World Courier and Mr. Mark Woolf, Director, Depot Networks, Catalent, will co-present, exploring ways of managing the complexity of supplying clinical trials in emerging markets.
Mr. Zhang joined Catalent in June 2013 as Quality Manager of its Shanghai site and now, as Quality Director, he is responsible for overseeing the Quality Management Systems at three Catalent sites in Asia. Prior to joining Catalent, he held roles in drug registration and quality assurance at CP Guojian, and at GE Healthcare where he worked in manufacturing and project quality. With over 15 years of experience in quality management, Mr. Zhang has hosted a number of inspections by Chinese and international regulatory authorities.
Ms. Flanagan has 12 years’ experience in global project and clinical supplies management within the industry, gained at several contract manufacturing organizations (CMOs). Initially at Almac for 8 years with roles in project management and clinical supplies management, she then worked at Fisher Clinical Services for two and a half years before moving to Catalent. Prior to joining the clinical trials industry, Ms. Flanagan worked as Quality Engineer in both the medical devices and semiconductor industries. She holds a bachelor’s degree in electrical and electronic engineering, and a master’s degree in materials science, both from Queen’s University Belfast.
Mr. Woolf has an extensive background in global distribution, having held previous positions at Zuellig Pharma Asia Pacific in the Philippines, and at Almac in both the U.K. and the U.S. He has significant expertise in pharmaceutical-related cold chain storage and distribution, which includes various operational logistics and business functions in Asia, Europe, the U.S., Latin America, and in the Middle East.
To arrange a meeting with any of the attending Catalent executives at the event, contact Richard Kerns at NEPR – [email protected]
Catalent is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products. With 85 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. Catalent employs over 11,000 people, including over 1,800 scientists, at more than 30 facilities across five continents, and in fiscal 2018 generated approximately $2.5 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey. For more information, visit http://www.catalent.com.
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