PharmaQMtraining.eu


Speakers on this course:


Dr Mike Robertson
BPharm PhD MRPharmS
CChem MRSC CSci FTOPRA

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
FRSC Hon MRPharmS

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 

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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.

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