Dr Mike Robertson
BPharm PhD MRPharmS

Mike Robertson designs our courses and he has created over 50 public conferences for various conference providers and he has written and personally delivered hundreds of lectures for public and professional organisations in Europe and North America

He is a Visiting Lecturer at King's College, University of London

He is a Quality Assessor on the WHO Prequalification Programme (Geneva – Copenhagen) and he also writes scientific papers on CMC subjects

Previously, for almost 20 years, Mike worked at the Medicines Control Agency (MCA), now the Medicines and Healthcare products Regulatory Agency (MHRA) in London, first as a Pre-Clinical Assessor and then a Pharmaceutical Assessor.  In the latter role he assessed many hundreds of Marketing Authorisation (MA) new applications (for New and Existing Drug Products), and tens of thousands of Variation applications

Earlier, before becoming a regulatory assessor, Mike worked from 1969 to 1981 in the pharmaceutical industry gaining experience in Quality Control and Research & Development operations and became eligible to register as a Qualified Person
Derek Calam
MA DPhil CChem

Derek Calam is a Visiting Professor of Pharmaceutical Sciences, University of Strathclyde

He is a Member of the WHO Expert Panels for both Pharmaceuticals and Biologicals and Chairman of the WHO Committee responsible for allocating names to medical substances on a global basis and he is a UK-nominated Expert at the European Medicines Evaluation Agency (EMEA) in London

Derek was formerly Head of Chemistry Division at the National Institute for Biological Standards and Control

He has for more than 25 years advised the UK Regulatory Authority on quality matters concerning Chemistry, Pharmacy & Standards and Biological and Biotechnological medicine

He was formerly Chairman of the European Pharmacopoeia Commission and formerly Chairman of the British Pharmacopoeia Commission

He has also previously served as Chairman of the EDQM Steering Committee for Certification, Strasbourg 

BSc ARCS PhD MChemA MSc (Toxicology) MSc (Applied Statistics) FRSC MTOPRA

David Snodin is Principal, Xiphora Bipharma Consulting. He is a Fellow of the Royal Society of Chemistry, a Member of The Organisation for Professionals in Regulatory Affairs and a Registered Euro Toxicologist

He is an experienced international lecturer and author of many scientific papers on Safety Evaluation of Biopharmaceuticals and specialises particularly on carcinogenicity and genotoxicity issues in medicines development

Previously he has worked in the food and pharmaceutical industries and for 11 years he was an Expert Preclinical Assessor at the UK Medicines Control Agency (now the MHRA) where he served as UK representative on the CPMP Safety Working Party

Recently for over 8 years he was Vice President Nonclinical at PAREXEL Drug Development Consulting

Paul Fleming
BSc MSc MRPharmS

Paul Fleming is Technical Director of the British Generic Manufacturers Association (BGMA). BGMA represents and promotes the views of the generic medicines industry in UK and has close and regular discussions with MHRA, other parts of the Department of Health and the NHS.  At a European level, he is a key Member of the Regulatory Committee of the European Generic Medicines Association, EGA.  In both these roles, Paul is involved in the development and implementation of new regulatory guidance.

Paul has spent 15 years working for the generic sector of the pharmaceutical industry in Europe in a variety of senior board level roles covering drug regulation, pharmacovigilance and formulation development.  In the 1990s he spent six years with the MHRA as a Pharmaceutical Assessor and still holds a formal position as an Expert to the British Pharmacopoeia Commission.  He is an experienced and accomplished Lecturer.

Mark Richardson

Mark Richardson is an independent consultant in drug development regulatory affairs for small molecule, biotech and advanced therapy products for clients in Europe, the US and the Asia-Pacific region.

After postdoctoral research in molecular biology at the Universities of Dundee and California at Berkeley, he joined British Biotech in 1988 to work on recombinant vaccines before becoming Head of Assay Development, then Biopharmaceutical Development Manager, and subsequently moving into Regulatory Affairs with responsibility for rDNA products in preclinical and clinical development. In 1997, he moved to Groupe Fournier as Head of the Gene Therapy Development Unit to lead a European oncology clinical development program.  Joining the CRO sector in 1999, first with Orion Clinical Services and later with i3 Research, Dr. Richardson headed and expanded the Regulatory Affairs departments providing advisory and regulatory support for global development and clinical investigation of recombinant protein (including biosimilars), gene and cell therapy products, as well as for small molecule drugs.  He has extensive experience of interactions with regulatory authorities in Europe and North America and was involved in the development of ICH and EU guidance for guidance for rDNA products.  More recently Mark has worked with companies establishing regulatory strategy for development programmes, seeking Scientific Advice, obtaining orphan product designations, developing Paediatric Investigation Plans, conducting regulatory due diligence for in-licensing opportunities and has acted as an expert witness in civil litigation.

Mark is involved in the teaching of regulatory affairs to undergraduate and postgraduate students at University College London and to industry professionals through TOPRA and Management Forum.  He presents frequently at industry conferences on developments in drug regulation

In September 2008, Mark became an independent consultant with the establishment of Richardson Associates Regulatory Affairs Ltd, and he has been providing regulatory support and oversight for biotech start up, large pharma companies and CROs.  He has a bachelors degree in Cell & Molecular Biology and a PhD in Biophysics from the University of London, was elected a Fellow of The Organisation for Professionals in Regulatory Affairs in 2005 and is a European Commission designated Expert for scientific and regulatory compliance review of EU R&D funding applications (FP7 Innovation).


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