SubscribeManagement Forum Ltd (MFL) runs over 300 conferences, seminars and teleconferencing events every year.
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)
This month MFL is focusing on two conferences. The first of these is:
EU DRUGS REGULATION FROM DISCOVERY TO MARKETING AND BEYOND
Legal, Administrative, Non-clinical, Clinical, Chemical and Pharmaceutical Aspects for Licensing and Post-Licensing
This is a new Regulatory Science meeting to be held in London in early September 2008 with an exciting panel of highly-regarded speakers from various appropriate disciplines.
Chairman and Speaker: Dr M I Robertson (Pharmacist) (see Panel)
Speakers: Dr Hans van Bronswijk (Clinician), Principal Consultant, European Drug Development Practice, PAREXEL Consulting, UK
Dr Hugh Delargy (Pharmacist), (see Panel)
Dr Peter Feldschreiber (Clinician and Barrister), Barrister, Four New Square, Lincoln’s Inn, London, UK
Dr Gerald Haase (Clinician, Principal Consultant, Haase Consultancy Services Limited, UK)
Dr Gareth Morgan (Molecular Biologist and Lawyer), Associate and Solicitor Advocate, Taylor Wessing, London, UK
Dr David Snodin (Toxicologist and Chemist), Vice President - Non-clinical, PAREXEL Drug Development, Consulting, UK
These experts will focus on the legal, scientific (chemical, pharmaceutical, non-clinical) and clinical activities necessary to take a candidate molecule from multi-disciplinary laboratory stages through clinical trial (CT) phases, marketing authorisation (MA) approval prior to EU marketing and subsequent MA maintenance through post-licensing variation activities.
Before licensing approvals can be achieved, pharmaceutical, non-clinical and clinical assessors must be reassured on many important scientific and technical issues and these will be explained in the conference. There will be emphasis on necessary data generation andpreparation of different types of application at various stages of CT and MA approval processes with advice on what regulators expect to see.
The speakers are highly experienced in their respective fields embracing EU law, chemical/ pharmaceutical science, non-clinical science and regulatory clinical medicine. They will be accessible through discussion periods and informal networking opportunities. Six of the expert panel currently work or have worked within various regulatory authorities.
Training will be delivered by formal lectures and by working in less formal, interactive groups conducive to relaxed but intensive learning. Delegates, likely to be relatively new to regulatory affairs or experienced in one or two areas but wanting to understand the bigger picture, should benefit enormously from the broad but focused coverage of the current EU regulatory licensing processes.
MFL recommends this conference to you if you want to see and better understand how to navigate EU pharmaceutical legislation and guidelines and to gain a regulatory appreciation of the application content that has to be generated through the clinical trials, licensing and post-licensing phases in the life cycle of modern medicines.
The second conference that MFL is featuring is to be held next in Barcelona in November 2008 and has broad objectives and a long title, as befits its extensive scope:
THE EU PHARMACEUTICAL DOSSIER, CTD MODULES 2.3 and 3
Understanding the CHEMISTRY, MANUFACTURING AND CONTROL (CMC) ISSUES supporting regulatory applications for MARKETING AUTHORISATIONS
Chairman and Speaker: Dr M I Robertson (see Panel)
Professor Derek Calam, OBE (see Panel)
Dr Hugh Delargy (Pharmacist), (see Panel)
The key objective of this popular meeting, which has evolved over many years and been delivered in London, Cork, Budapest, Barcelona and Nice, is to inform delegates about the CMC issues that underpin a successful marketing authorisation application. Delegates learn about the key components of the EU licensing systems for substances for pharmaceutical use and for finished medicinal products.
Delegates receive introductions to the EU Regulatory System showing how and where European bodies, institutions and agencies impact of the control of pharmaceuticals. They learn about sources of official information from the European Commission, the European Directorate for the Quality of Medicines (EDQM) and the European Medicines Agency (EMEA). They hear about key parts of European legislation and about expert guidelines including those from the International Conference on Harmonisation (ICH).
Delegates learn about the hierarchy of pharmacopoeias in Europe which provide many things including publicly-available standards for human and veterinary medicinal products, their ingredients and containers. Also included is coverage of General Notices, General Chapters, General Texts, General Monographs and the role of individual specified monographs. An understanding of the structure of the European Pharmacopoeia is important to its correct use and delegates receive lots of information about technical procedures and other tests and limits, with many case examples, in order to improve awareness. Explanations are given to delegates about how pharmacopoeial content is often mandatory in its effect, an attribute which in recent years has grown considerably and must not be overlooked.
Attention then turns towards the preparation of the ‘Quality’ (CMC) parts of the Common Technical Document (CTD) (in CTD Modules 1.3, 2.3 and 3) and the importance of achieving a high standard of clear, relevant, focused but complete documentation. All the sections of Module 3 for Drug Substance and Drug Product are examined and the speakers use their extensive regulatory experiences to illuminate the issues that need to be understood and addressed by applicants for marketing authorisations. A small selection of these include features on
- control of substances for pharmaceutical use whether derived from chemical synthesis, from biological sources including fermentation processes, or from mineral extraction
- the European approach to minimising TSE risk
- pharmaceutical development
- manufacture of the dosage form
- stability
- validation of testing methods
- preparing and justifying specifications
Delegates hear about the Quality Overall Summary (CTD Module 2.3) and how to create it to serve its purpose. Interesting case examples are presented to reinforce learning.
In the conference, attention is often given to common deficiencies in the pharmaceutical dossier, as this knowledge can be very helpful background information.
The scope of the conference is ambitiously wide and the content is useful both as an introductory course and as a refresher course to people who need to have an up-to-date and broad knowledge of the subject areas. The speakers include numerous examples to illustrate their talks because they know from past experience that audiences strongly favour this approach. There are also short workshops wherein the delegates work in groups to consider regulatory CMC issues in a way that reinforces the more formal teaching experiences.
Better CTD documentation and getting it 'right first time' reduces the likelihood of deficiency questions from the pharmaceutical assessors, saves a company much unproductive and expensive waiting time and improves the chances of commercial success for the applicant company.
MFL recommends this conference to you if you want to gain regulatory insight from experts and improve your knowledge and understanding of the pharmaceutical issues that are important to CTD preparation and a successful marketing authorisation application.
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.