Specialist Pharmaceutical Regulatory Conferences

Within this figure has been and is a specialist collection of  6 - 12 conferences a year, which are specially designed for MFL by Dr Mike Robertson (see below).

A common thread throughout these specialist meetings is the opportunity afforded to delegates to gain insight from and to have ready access to speakers who have many years’ collective, regulatory experience working in licensing authorities, control laboratories and pharmacopoeias.

In the carefully-planned programmes, delegates receive up-to-date and forward-looking training in various regulatory areas of chemical and pharmaceutical importance.

In some programmes, the core panel of speakers (see panel) is boosted by additional presenters with industrial, legal and academic experience but even these experts have usually interacted closely with or actually worked for the authorities in licensing, control and inspection and enforcement situations.

In yet other conferences, the additional speakers may be clinicians, toxicologists, microbiologists, biotechnologists or engineers, all chosen because of their specialist expertise in the conference subjects.

These specialist meetings created by Dr Robertson provide unparalleled opportunities to appreciate how the authorities approach both routine and less common, chemistry, manufacturing and control (CMC) issues connected with marketing authorisations both at the application stages and subsequently during the authorised product life cycle.

Apart from listening to high-quality, well-focused lectures, delegates can bring their questions on chemistry and pharmacy matters to the open part of the proceedings or give them an airing in private discussions with the experts during scheduled breaks.

Because of the experiences of these panels of speakers, delegates really can find out and learn what assessors expect, indeed often require, in the complex and diverse world of modern medicines regulation.

Delegates will find that these meetings give them access to and a chance to draw on an impressive amount of regulatory experience and expertise.

If you work in

• regulatory affairs
• or in other departments of the pharmaceutical industry such as
  • formulation or pharmaceutical development
  • analytical research and development
  • Quality Control or Quality Assurance

where you need to understand the interface between your actions and the requirements and expectations of the competent authorities, MFL invite you to read on in order to learn more about the content of Dr Robertson’s conferences.

Each month in this web site article, MFL will focus on several forthcoming events.

Dr Robertson’s MFL conference portfolio includes:

• Active ingredients
• Drug Master Files and Certificates of Suitability
• EU Chemistry and Pharmacy Regulatory Procedures and Requirements for Marketing Authorisation Applications
• EU Drugs Regulation from Discovery To Marketing and Beyond
• Excipients
• Impurities
• Products of Mammalian Cell Culture
• Products of Microbial Fermentation
• Solid Oral Dosage Forms
• Stability *
• Topicals: Creams, Liquids, Ointments and Transdermal Patches
  * (Co-designed with Dr Hugh Delargy, see below)
  

Designer of and Chairman and Speaker at a series of specialist pharmaceutical regulatory conferences

Dr Mike Robertson established the pharmaceutical regulatory consultancy Pharmaceutical Quality Matters in September 2000.  As Principal European Regulatory Affairs Consultant he specialises in providing companies with regulatory advice, insight and training on chemistry and pharmacy (CMC) topics, on regulatory strategy and when and how to take scientific advice all concerning intended and approved marketing authorisations.

He is also a Visiting Lecturer at Kings College, London University, a Member of the British Pharmacopoeia Commission’s Committee on Excipients, a Registered Pharmacist, Chartered Chemist, Chartered Scientist and a Fellow of the Organisation for Professionals in Regulatory Affairs.  He is a Quality Assessor on the WHO Prequalification Programme (Geneva – Copenhagen).  He also lectures internationally and writes scientific papers on CMC subjects.

Previously, for almost 20 years, Dr Robertson worked at the Medicines Control Agency in London, first as a Pre-Clinical Assessor and then as a Pharmaceutical Assessor. In the latter role he assessed Clinical Trial and Marketing Authorisation applications for New Active Substances and New Products, and Abridged and Variation applications for Existing Active Substances and associated Products.  He was a UK-nominated Expert at the EMEA in London, a UK Rapporteur for the Certificate of Suitability (CEP) Procedure at the European Directorate for the Quality of Medicines (EDQM) in Strasbourg, a Member of the Technical Advisory Board for the CEP Procedure and a Member of the United Kingdom Delegation to the European Pharmacopoeia Commission.

Professor Derek Calam, OBE is a current Member of the UK’s Commission on Human Medicines and Chairman of that Commission’s Expert Advisory Group on Chemistry, Pharmacy and Standards.

Previously he advised the UK Regulatory Authority on quality matters for more than 20 years serving on both Chemistry, Pharmacy & Standards and the Biologicals Sub-Committees of the Committee on Safety of Medicines

He is a Member of and formerly Chairman of the EDQM Steering Committee for Certification, Strasbourg.  He was formerly Chairman of the European Pharmacopoeia Commission and formerly Chairman of the British Pharmacopoeia Commission.

He is a Visiting Professor of Pharmaceutical Sciences, University of Strathclyde, formerly Head of Chemistry Division at the National Institute for Biological Standards and Control and 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.

Dr Hugh Delargy is Principal Consultant, Hugh Delargy Associates Limited, a pharmaceutical regulatory consultancy. 

He is also a Quality Assessor on the WHO Prequalification Programme, a scientific author, an international lecturer in pharmaceutical subjects and a registered pharmacist. 

Previously for four years, he was a Senior Associate Director in Regulatory Affairs with Pfizer Global Research and Development and also previously for seven years a Senior Pharmaceutical Assessor with the UK’s Medicines Control Agency [now Medicines and Healthcare products Regulatory Agency (MHRA)] and a UK-nominated Expert to the European Medicines Agency (EMEA).  Earlier he was also a Senior Manager in Pharmaceutical R&D for a division of Bristol-Myers Squibb with a focus on development of analytical methods, stability testing and formulation innovation.