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 100 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 


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 Manufacturers 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.

Carl Mroz
Carl Mroz is currently the Director of Global Regulatory Affairs, EMEA for Colorcon Limited in the UK.

He is an active member of the International Pharmaceutical Excipients Council (IPEC) Europe, as the Chair of the Quality and Regulatory Affairs Committee and is also a member of the European Pharmacopoeia Working Party on Functionality Related Characteristics, a member of the British Pharmacopoeia Working Party on Excipients and the Panel of Experts on Inorganic Chemicals.

He is an active international lecturer with particular expertise on compounded excipients used in conjunction with solid oral dosage forms.

Carl is a past Chair of IPEC Europe and has been involved with the pharmaceutical industry for over 30 years in a variety of roles including Production, Quality Control, Regulatory Affairs and Quality Assurance.

He is a graduate in Chemistry.



Geoff Mellor is Technical Director of the British Association of Pharmaceutical Wholesalers (BAPW) which represents full-line pharmaceutical wholesalers in the UK. BAPW is a Member of the Brussels based European Association of Pharmaceutical Full-line Wholesalers, the GIRP.

Geoff leads on all technical, regulatory and liaison aspects for the BAPW including being the primary contact with the MHRA. He is also a member of the GIRP Technical Committee, which covers aspects of health policy developments within the European Union.

 



Steve Porter is a highly experienced Quality Professional with over 35 years’ service in the Pharmaceutical Industry. He is currently a Company Director at Steve Porter Pharma Consulting providing services in internal and supplier auditing, quality system design and enhancement, regulatory inspection preparations and remedial actions, design and delivery of training courses, supply chain design and evaluation, and QP services.

Steve has extensive auditing experience in the US, Europe and Asia (China, India, Japan). He has also served as a Board Member of IPEC Europe. He is an experienced International lecturer.

Steve is a Fellow of the Royal Society of Chemistry.

Until recently he was QA Director (Compliance), Global External Sourcing at Astra Zeneca. His many duties there included involvement with the company’s preparations for compliance with the Falsified Medicines Directive.

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