Meet our Pharma Training experts

Michael Gamlen

Michael is managing director of Pharmaceutical Development Services Limited, a Nottingham UK-based technical consultancy. Michael has over 30 years experience of tablet development. Awarded a first class honours degree in pharmacy, specialising in pharmaceutical engineering. He studied for a PhD at Nottingham University. He was head of tablet development at the The Wellcome Foundation for 15 years, and has since worked for Vanguard Medica Limited and as a consultant. He specialises in managing product development, formulation, tablet and process development studies. He has been teaching professional tabletting courses for many years. His courses are highly rated, often exceeding the expectation of participants.

Michael continually updates the content of his courses with guidance and extracts from latest scientific papers. He provides a substantial amount of relevant literature to all course participants and copies of all notes and guidance used. He is very popular presenter.

Dipankar Dey

Dipankar is Oxford educated doctoral graduate with extensive senior management experience in the pharmaceutical and medical diagnostics industries.

Dipankar joined PharmaTraining Ltd from Oystar Manesty (Liverpool) where he was Head of Process Development. He has particular expertise in manufacturing of solid dose and bio-pharmaceuticals and has worked in a number of different functions including technology transfer, new product development, training and manufacturing. He also has experience in film coating and the implementation of PAT.

David Inglis

David is a consultant specialising in GMP/Quality Assurance for the manufacturing sectors of the pharmaceutical and consumer healthcare industry. He has extensive experience in assessment and improvement of QA/GMP systems, auditing, GMP training, inspection preparation and plant cleaning / decontamination, especially in bulk intermediates and APIs. He has a PhD in enzyme chemistry (affinity chromatography).

With over 30 years experience in quality assurance in the pharmaceutical industry, David has extensive experience of quality management, through roles in QA laboratories, GMP compliance and regulatory compliance. He successfully pioneered automated HPLC methods, then managed all aspects of QC laboratories before spending the following 11 years managing and developing quality assurance, including documentation, control of change, auditing and routine regulatory compliance to cGMP. He is a 'qualified person' under EU Regulations, formerly for bulk sterile antibiotics and now for bulk product intermediates for use in clinical trials.

David is an experienced international auditor of suppliers and contractors and has successfully prepared several sites for FDA/MHRA inspections, including FDA "Systems" based inspections. He has extensive experience of being the lead spokesman during major regulatory audits.

David is a specialist in cGMP training and QA system improvement. His flagship improvement package details a system of secure GMP compliance at competitive cost. For conceiving and developing this package, David received the highest level of recognition for excellence from a global pharmaceutical manufacturing company.

Roland Collicott

As an experienced consultant Roland provides assistance to the pharmaceutical industry in the areas of chiral analysis, polymorphic characterisation, stability studies, chemical analysis in a GMP environment, specifications and all aspects of international CMC documentation. He also runs training courses to cover many areas of analytical chemistry, particularly in chromatography, chiral and polymorphic analysis. He has served as an expert witness and consulted in trials in Canada, UK, South Africa and Germany.

Before becoming a consultant in 2005, Roland was analytical section manager at OSI Pharmaceuticals responsible for delivering validated analytical chemistry methods and CMC documentation for OSIs regulatory submissions. In this role, he was responsible for collating and interpreting data from a wide range of analytical techniques, acquired in-house or at contract, for the characterisation of new compounds. There he also gained valuable international experience, working closely with regulatory and clinical groups as well as manufacturing and analytical contractors in Asia, Europe and the US.

Roland began his career in physical chemistry at Glaxo Group Research and originally specialised in chromatography, introducing the use of chiral HPLC columns to resolve enantiomers. He gained a PhD from his research into novel silicon-based chiral derivatisation reagents for HPLC, GC and NMR analysis. In 1998 he joined British Biotech, where he became involved in many other areas of analytical chemistry including polymorphism in pharmaceutical products. As Group Leader, he managed British Biotech's QC procedures, stability testing and the analytical development of its NCEs.

Chris Barnett

Chris is an independent GMP and compliance consultancy. Chris has a talent for coaching and explaining complex regulations in a straightforward manner. He recently spent time in India patiently explaining regulatory procedures to people unfamiliar with European practices. Chris is an expert in quality management, technology transfer and new product introduction.

Chris has a background as an analytical chemist and over 20 years experience in QA roles, with the Wellcome Foundation and GlaxoSmithKline. He has had QA management posts in India and Mexico, as well as new product introduction project management roles in pharma manufacturing. Chris ran his own consulting company for several years prior to joining PDS in 2002.

Chris graduated from Cambridge in natural sciences, with an MSc in analytical chemistry, and subsequently an MBA from Greenwich University.

Pauline McGregor

Pauline has 20 years experience working for pharmaceutical companies and contract testing laboratories in both Canada and the UK.

She completed her honours degree in Scotland on a part time basis while employed full-time. She left the industry to pursue her PhD in photo organic chemistry where she also taught analytical techniques to undergraduate students. On completing her PhD in 1995, she travelled to UWO in London, Ontario, Canada to complete her post doctoral studies. She is an experienced trainer and has been delivering cGMP and validation training for the past 15 years. She is rated very highly as a presenter.

Since then she has worked as a validation specialist at Pfizer, manager of research, development and validation at SGS Life Sciences, a consultant to the pharmaceutical industry and has taught analytical R&D, method validation, GMP and related quality systems courses across Canada, in the US and China.

Throughout her career, Pauline has identified a lack of shared knowledge between manufacturing, quality control, R&D and quality assurance sectors in the healthcare industries. She believes there is a need for cross education and training to allow the different disciplines to communicate with each other so that realistic objectives can be met by all in a timely manner with a harmonised understanding.

Pauline is also a member of The Royal Society of Chemistry, UK and listed on the RSC Directory of Consultants.

Ralph White

Ralph is a specialist in learning and development work for the pharmaceutical/biotechnology industries. Ralph has over 25 years experience in the industry as a scientist, project manager and learning & development specialist.

John Faulkes

John is Director of Team Communications Development, and is an expert in organisation and team development, specialising particularly in cross-function working /matrix organisations. He has over 15 years experience working with the pharma/biotech sectors as well as in general manufacturing, sales and the public sector.

Paul Cummings

Paul is a Pharmaceutical Consultant with nearly 30 years experience in Pharmaceutical R&D specializing in sterile / parenteral product development including product formulation development, development plans, contamination control, strategic assessments, due diligence activities, specialist auditing of parenteral facilities to cGMP, troubleshooting, microbial contamination and design of parenteral manufacturing facilities.

He spent 24 years at GSK in various technical roles including Director Pharmaceutical Development. Paul is a Chartered Biologist and a Fellow of the Society of Biology and is an expert in pharmaceutical radiation safety, ADME study design and implementation. He has vast regulatory experience with European and FDA agencies and authorship of numerous regulatory submissions including INDs, NDAs, aNDAs, MAAs and CTXs. A proven track record for teaching, mentoring and coaching with many years managerial experience at all levels.

Paul Butler

Paul is an independent consultant specialising in Facility Design, Validation, and GMP Compliance for the manufacturing sectors of the pharmaceutical and consumer healthcare industry. He has over 40 years experience working in and with the pharmaceutical industry, the last 24 as a consultant. He has a BSc in Medicinal Chemistry.

He has extensive experience in the design and specification of international regulatory compliant secondary production plants, including a number of very large non-sterile and sterile facilities, assessment and improvement of GMP systems, auditing - both API and Secondary facilities, hands-on GMP training, and inspection preparation. He has worked with most of the worlds multinationals, as well as many smaller companies around the world, working in almost all European countries, the Middle East, Africa, the Indian sub-continent, and the Far East.

Before becoming a consultant in 1988, Paul had 15 years experience as a production/works manager, working with small to medium sized companies mostly involved in the production of oral solid dosage and liquid products. His experience also included 2 years working with a homoeopathic products manufacturer

Annie Dallison

Annie has over 25 year experience and an impressive track record of hundreds of successful and innovative branded international product launches for Boots The Chemist, Boots Healthcare International & Reckitt Benckiser Healthcare International. These include global brands such as Nurofen, Strepsils, Optrex, Lemsip and Gaviscon.

She is experienced in all elements of packaging and product development from concept through to commercialisation. Incorporating: Feasibility, COGS, reduction, Procurement, Consumer testing, Production requirements, Graphics development, legal and trade requirements.

She is also an active member of the Pharmaceutical Forum, where she is proactively invoved in the establishment of the BSI & CEN Standard for Braille on Packaging.

Graham Blakey

Graham Blakey is an advocate of creative and efficient clinical study design and has applied these principles across a range of global drug development projects in several therapeutic areas. In his current role he has provided support to large pharma and smaller biotech companies. This has involved evaluation of regulatory submissions concerning the biopharmaceutical aspects of re-formulated generic drugs and project management of the clinical pharmacology side of novel drug development. At AstraZeneca he was a principal scientist where he developed strategic drug-drug interaction thinking within the clinical function.

Graham holds a BSc (Hons) degree in Pharmacy and is a member of the Royal Pharmaceutical Society. He has an MSc in Clinical Pharmacology and a PhD from the University of Manchester.

Wilfried Niessen

Wilfried has almost 30 years of experience as a researcher and project manager in the field of analytical mass spectrometry, and especially liquid chromatography mass spectrometry. Since 1996, he has worked as an independent consultant, providing expert consultancy and (advanced) courses in analytical mass spectrometry. In 2002, he was appointed (part-time) extraordinary professor in bioanalytical mass spectrometry at the Faculty of Science of the VU University in Amsterdam, where he is currently interim Head of the Division BioMolecular Analysis.

Wilfried has been involved in many different consultancy projects within industry, governmental institutes and other laboratories in the Netherlands, Belgium, Italy, Germany, Denmark, Sweden, United Kingdom, Switzerland, Slovenia, Israel, Hong Kong China, India, and Canada. In addition, in the past 14 years he provided more than 320 courses with in total more than 3400 participants. He is (co)author of more than 160 refereed papers in the field of LC-MS. The third edition of his book Liquid Chromatography - Mass Spectrometry was published in October 2006. He co-edited several special volumes of Journal of Chromatography A (794, 970, 974, 1058, 1067, and 1159) on "Mass Spectrometry: Innovation and Application". He is the editor of Volume 8: Hyphenated Methods of the Encyclopaedia of Mass Spectrometry, published in 2006 by Elsevier.

William van Dongen

William holds a PhD (1996) in peptide and protein mass spectrometry. He has worked as an industrial researcher, project manager and laboratory manager in the field of bioanalytical mass spectrometry and liquid chromatography - mass spectrometry. He was responsible for setting up the bioanalytical LC-MS facility of Pharma Bio-Research (currently PRA International), one of the first contract laboratories offering commercial LC-MS services to the pharma industry. He has almost ten years experience as study director of bioanalytical LC-MS studies. He started up the mass spectrometry facilities for the generic pharmaceutical company Synthon and for his current employer PROXY, a pharma contract laboratory.

He is (co-) author of 25 refereed papers in the field of protein and peptide mass spectrometry and bioanalytical LC-MS.

Mike Cliff

Mike is an independent training consultant specialising in the area of oral solid dosage manufacturing technology. Mike has been a regular presenter at courses and training events in his 34 year association with the process industries. An expert in oral solid dosage process technology, facility design, commissioning and start-up, Mike specialises in granulation and containment technology. Mike has a background as a chemical engineer with over 30 years experience in technology development and facility design roles, with the ICI, Zeneca and AstraZeneca. He has had experience of working on OSD facility projects in the UK, France, Germany, US, Sweden, Puerto Rico and Egypt. Mike has also been instrumental in introducing new technologies into the business such as microwave and continuous processing.

Mike graduated from Bradford with a degree in Chemical Engineering and a PhD on mixing technology.

Hedley Rees

Hedley has had many years in the pharma and biotech industry working with high profile biotech and emerging specialty pharmaceutical companies to bring new 'molecular' entities and re-profiled compounds through development stages into full scale commercial launch. He has been a key contributor to trial progression and commercial launch across all phases of development in multiple territories and global markets.

Hedley was responsible for managing global supply chains in big pharma companies such as Bayer and Johnson & Johnson. Here, he built a wide competency base in all the disciplines of supply chain management, implementing and using state-of-the-art information systems enablement. He holds an Executive Master's in Business Administration from Cranfield University School of Management, a degree in production and industrial engineering from the University of Wales and is a full corporate member of the Chartered Institute of Purchasing and Supply (CIPS). Hedley sits on the Bioindustry Association's Manufacturing Advisory Committee and has previously lectured strategic supply chain management for the CIPS professional stage examinations.