The WHO Prequalification Team provides advice to UN agencies and international medicine procurers on the quality, safety and efficacy of purchased medicines. In most cases, eligibility for procurement requires the medicine to be either approved by a Stringent Regulatory agency or prequalified by the WHO Prequalification Team.
This presentation will provide an introduction to the medicine and API prequalification programme including: who may apply, what are the requirements and procedures. The possibility for arranging technical assistance to potential manufacturers who wish to participate will be outlined.
Finally, the presentation will also introduce the WHO collaborative procedure. This is a procedure introduced to significantly reduce national registration times for prequalified products, allowing sales of the medicine to the local market quickly. The procedure requests a decision from the national medicines authority within 90 days. Nearly 30 countries are now participating in this scheme.
Dr. Hussain distributes time between his consulting practice (http://www.ajazhussain.com/ ) and his role as the President of the National Institute for Pharmaceutical Technology and Education (http://www.nipte.org/). He trained as a pharmacist at the Bombay College of Pharmacy, India; and received his Doctoral degree from the University of Cincinnati. His career path is diverse – academician, US FDA regulator, senior executive (in pharma and tobacco sector) and now an advisor and consultant with support for academia. He is passionate about making high pharmaceutical quality affordable and shares his view on the topic around the world and on his LinkedIn page (https://www.linkedin.com/in/ajazshussain ).
Pharmaceuticals and Medical Device Agency
Office of Manufacturing/Quality and Compliance
Division of Pharmaceuticals
2015.1- Ministry of Health, Labour and Welfare
2011.4- Pharmaceuticals and Medical Device Agency
Office of Manufacturing/Quality and Compliance
Division of Medical devices
Bachelor of Pharmaceuticals and Master of Pharmaceuticals from The University of Tokyo(Japan)
Elodie Lebastard is Manager Food Law at EAS Strategies, European office, providing regulatory and strategic advice at the EU and national levels. Elodie is a lawyer specialised in food law (University of Nantes – France, and University of Zaragoza – Spain). Before joining EAS in 2008, she worked as a regulatory affairs consultant in France, and has completed a traineeship at the European Commission, DG SANCO, Food Law, Nutrition and Labelling Unit, working on food supplements and nutrition labelling EU regulations and policies. She advises clients on classification of products, status of ingredients, labelling compliance, nutrition and health claims, marketing procedures and provides specific advice on the mutual recognition principle across the EU. Elodie has spoken at numerous European and international conferences on food supplements, dietetic foods and functional foods.
Dr. Claudia Lin is a China 1000 Innovation Talent Award recipient. She obtained her Ph.D degree in Cell and Molecular Biology from University of California at Berkeley. For the past 15 years, her career has been focused on CMC, manufacturing and Quality. Dr. Lin held various Quality leadership positions in Genentech/ROCHE including QA and QC functions for clinical development, as well as technology transfer and Annual Product Quality Review for ROCHE global commercial biologics portfolio. Afterwards, she was head of Quality Assurance for Bayer Healthcare Biotech division in California, responsible for all products in clinical development. She was also involved in the work of global leading monoclonal antibody products listing. When Dr. Lin first came back to China in early 2015, she worked as senior executives at two leading Chinese biopharmaceutical companies, responsible for GMP compliance, Quality management and product development. In May last year, Dr. Lin founded Suzhou AABioQ Pharmaceutical Co., Ltd. -- Contract Quality Organization (CQO), providing biopharmaceutical enterprises with comprehensive CMC quality management services.
Mrs. Marieke van Dalen works as the Global Regulatory Specialist for Aspen Oss B.V., a company located in the Netherlands, producing a wide variety of APIs. These APIs are sold on a global scale and thus registrations are supported in many regions of the world.
Marieke is also a Board Member of APIC (Active Pharmaceutical Ingredients Committee), which is the Technical European Industry Association for API producers, based in Brussels. She often represents the European API industry in meetings with health authorities and in the Observers meeting at ICH.