Annual CMC Conference

Head of Section Test and Therapy Allergens

Head of department of pharmaceutical assessment for chemical and herbal products

Scientific Officer & Head of Section for Revisions within the Certification of Substances Department Dr Andrew McMath graduated in Pharmacy from the School of Pharmacy Portsmouth, UK and was registered with the Royal Pharmaceutical Society of Great Britain from 1987 to 2004. Following registration he worked in retail and hospital pharmacy and then in teaching. He studied for a post-graduate degree followed by a PhD in Medicinal Chemistry at ‘la Faculté de Pharmacie’, Université Paris V. He received his PhD in 1997. He then joined l’Agence du Médicament, Paris (now ‘Agence nationale de sécurité du médicament et des produits de santé’) as Pharmaceutical Assessor. In 1999, he joined the EDQM Certification of Substances Division as Scientific Officer. After having assumed the role of Head of Section for new applications he is currently Head of Section for Revisions within the Certification of Substances Department.
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Market Compliance Manager, Rapporteur ICH Q9 (EC, Europe)

Pharmacist - Global Regulatory Affairs

Regulatory Affairs Consultant

Associate Director, Head of Regulatory Affairs India

President & CEO Dr Mohamed Oubihi is the President and CEO of YAKUMED, a company specialised in the Japanese pharmaceutical and cell and gene therapy markets. YAKUMED provides a wide range of strategic and operational services spanning the commercial, regulatory affairs, pricing, safety, drug development and business development areas. Dr Oubihi has unique expertise in the Japanese pharmaceutical market. He has more than 20 years' experience in the bio and pharmaceutical industry, having worked for companies such as Biogen, Novozyme and Abbott/AbbVie. Dr Oubihi has been involved in regulatory affairs, drug development, market access and business development, and has successfully helped more than 40 small and medium-sized pharmaceutical companies break into the Japanese market.
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Head of Product Market Authorization and Quality Assurance, PhD in Pharmaceutical Chemistry. 20 years in regulatory area in total: for 6 years - Tutor of Pharmaceutical Chemistry at Pharmaceutical State University (Pyatigorsk, Russia), 9 years of experience in Drug Product development for Russian manufacturers and 6 years - in local batch release quality control; 11 years in Big Pharma RA departments.

Over 25 years of regulatory, quality, clinical trial and pharmacovigilance experience in Asia with good knowledge in the field of nutritional, pharmaceuticals, medical devices, consumer healthcare and biological products. Externally, playing a leading role among all the regional regulatory professionals in AHWP (Asian Harmonization Working Party). Being the founder of ARPA (Asia Regulatory Professionals Associations) since 2010 with over 4800 members. Adjunct Lectureship & Visiting Professorship with Nanyang Technological University (Singapore), Tohoku University (Japan), Beijing University (China), Chinese University of Hong Kong (Hong Kong), University of Hong Kong (Hong Kong), Taipei Technical University (Taiwan), University of Sydney (Australia), Dongguk University (Korea)