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Topic
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Professor John Harrison is an acknowledged cognition expert whose principal professional interest is in helping people understand, maintain, and enhance their cognitive skills. He is Chief Scientific Officer at Scottish Brain Sciences where he...
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Dr. Samaa Al Tabbah holds a B.S. in Medical Laboratory Technology (MLT) from the American University of Beirut (AUB) and a Pharm D. in Clinical Pharmacy from the Lebanese American University (LAU). After graduation, Dr. Al Tabbah held a position...
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Mohammed Alkattan earned a BSc in Applied Chemistry in 2009 from Damascus University then worked as a Quality Control in Oubri Pharma. He then pursued an MSc in Drug Chemistry from the University of Newcastle, UK. After that, he was appointed as...
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After completing his degree in molecular biology at the University of Reading, Robert Alvarez has been at Lonza Biologics for 17 years, of which 14 were spent working in the product stability group and 2 as Head of Business Planning and...
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Dr. Tina Amini, a pharmacist with PhD in Pharmaceutics. She has over 30 years experience in Pharmaceutical and Medical Devices. She previously held the positions of Head of Notified Body and Senior Technical Specialist at LRQA Notified Body and...
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Rachel is a University of Aberdeen graduate with an honours degree in Pharmacology and a Masters degree in Drug Discovery and Development. Post-degree, Rachel joined Charles River Laboratories, Edinburgh as a Scientist in GLP Animal Health...
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Stuart Angell is a joint director in his own consultancy specialising in global regulatory affairs strategy and compliance for in vitro diagnostics and medical devices focusing on the transition to the new IVD/Medical Device Regulations, MDSAP...
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Dr Cheryl L Barton is an independent consultant with over 35 years' research and business analysis experience. Following her senior research positions in academia and seven years with Merck, in which she was responsible for a variety of CNS...
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Janette Benaddi is an Independent Consultant and previously the Director of Clinical & Consulting Europe for NAMSA. NAMSA is a global Medical Research Organization offering a breadth of services form preclinical to post market activities...
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Jitan Bhudia is a highly accomplished Pharmaceutical Consultant with extensive expertise in Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), and regulatory compliance within the pharmaceutical industry. With a career spanning...
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Dr Laura Brown MBA, BSc (Biochemistry), BSc (Psychology), PhD, Diploma in Clinical Science, FICR, is a Pharmaceutical Management and Training Consultant, Course Director for the MSc in Clinical Research at the University of Cardiff. She has more...
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Jason Brown brings a wealth of knowledge and practical experience to his role as Senior Analytical Sciences Manager at Adare Pharma Solutions, where he serves as the global nitrosamine subject matter expert. He has led Adare’s innovative...
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Laura’s areas of expertise include CMC strategy, technology transfer, process scale-up, validation, program management, GMP compliance and risk management. Laura has spent nearly 20 years in the industry where she has contributed to both small...
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A quality management professional, chartered biologist and member of the Royal Society of Biology, with over 35 years’ experience in the medical device, pharmaceutical, biotechnology and food industries. Extensive knowledge of quality and...
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Catarina Carrão from BioSciPons, is a clinical evaluation and benefit-risk assessment specialist. Previously, she studied Biochemistry and worked in academic research. In 2006, she was a Marie-Curie Early Stage Researcher in the...
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David is an Innovation Consultant specialising in digital health andhealthcare reimbursement. With a diverse background in healthcare innovation, David has held operational roles in industry-leading companies such as Johnson & Johnson (J&J) and...
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Dr Alan Chalmers is a pharmacist with over 35 industrial experiences mainly in the field of pharmaceutical regulatory affairs. A graduate of Strathclyde University in Glasgow with a B.Sc. in Pharmacy with specialisation in Pharmaceutical...
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Dale Charlton is a Freelance Consultant for automation and fill / finish. Dale has spent a lifelong career in Life Sciences and Biotechnology encompassing both the academic and industrial sectors. Dale worked in a technical capacity in basic R&D...
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Koen Cobbaert works for Philips as a quality, regulatory, and standards expert. Through trade associations COCIR and DITTA, he represents the industry at the European Commission and the IMDRF on matters related to software and artificial...
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Lekan Daramola is an independent consultant who specialises in supporting biotech companies during the critical early drug development activities, enabling successful preclinical and clinical decisions as they develop new drugs for...
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Bruce Davis runs his own training/consultancy company for science and risk based approaches to Engineering and Process Validation (PV), Quality by Design (QbD), Technology Transfer (TT), Quality Risk Management and other related topics. He has...
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Drug Safety Manager at Pharma To Market Mr. Param Dayal is a qualified Microbiologist with Master’s degree in Microbiology and a certified MedDRA coder. For the last 15 years, Param has worked on a variety of pharmacovigilance projects with...
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Mónica Dressler-Meyer is DRA Manager based in Switzerland with many years of regulatory experience. She has spent many years in DRA working with different pharmaceutical companies with responsibility for Asia Pacific and lately also for...
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Mustafa Edik is an Independent GMP Consultant and Auditor. After graduating as a Chemist from university, Mustafa began his 25 year plus career as a Laboratory Supervisor at Bayer, a German Pharmaceutical Company. After 15 years of working as...
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Craig Evans is a chemist with over 13 years experience in the veterinary medicines field, working on everything from initial registrations to post-approval activities including change controls captured with variations. Craig works directly with...
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Alex Evans is a pharmacist with over a decade of pharmacy practice experience. His first job was floating for a chain community pharmacy, before managing long-term care, community, and hospital outpatient pharmacies. He also served as a pharmacy...
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Mohammad has a unique blend of both technical and regulatory experience and qualifications gained from his more than 18 years of experience in the pharmaceutical industry. After graduating in pharmaceutical science from the University of Cairo,...
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Richard Featherstone is Research Director, Human Factors Research & Design, Emergo by UL, and previously Managing Director of Medical Device Usability Limited, a specialist human factors consultancy that works exclusively with new and emerging...
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Joanne Flitcroft is a qualified solicitor with over 22 years’ experience. She trained in the City of London and later specialised in pharmacovigilance as part of a FTSE 100 pharmaceutical company’s global legal team. Joanne founded Opallios in...
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Linda Garrod is a Quality Specialist at IVDeology Ltd, based in Kent, UK. She brings her exceptional quality experience from 20 years within the medical device industry, to support manufacturers in the creation and continual improvement of...
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Sayed K Goda, a biochemistry and drug discovery professor, has a robust academic background. He earned a BSc in Chemistry and an MSc in organic chemistry from Cairo University, Egypt. He then pursued a PhD in Biochemistry from the University of...
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Dr Alison Green is a clinical biochemist with over 30 years’ experience of working within the NHS and academia to develop and evaluate diagnostic tests for neurodegenerative diseases. She did her PhD at the National Hospital for Neurology and...
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Sarah is a postdoctoral researcher with a background in psychology, mental health and dementia clinical trials and large dementia prevention cohort studies. With experience of working in the NHS and academic institutions, she is particularly...
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Barbara is a Biochemist and a Medical Writer, Editor and Teacher by profession, with 20+ years’ experience in the pharmaceutical industry. Barbara has started her own medical writing and consultancy business (Hawkeye Medical Limited) and built...
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Dr Adrian Haines is a Senior Process Manager within MSAT at Sobi (Swedish Orphan Biovitrum). Adrian has extensive experience in generating mammalian cell lines suitable for the GMP production of biologics and is extensively involved in the...
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Susanne Hall began her career in 1990 at Dr. Karl Thomae (today known as Böhringer Ingelheim) in Biberach as Head of Packaging Technology. In 1993, she joined Vetter’s Research and Development department as Head of Packaging Material Incoming...
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Anna Harrington-Morozova is a regulatory, drug development and external relations professional with over 20 years’ experience gained working in a Regulatory Authority, academia and industry. Anna graduated in Russia as a pharmacist. After...
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Heba has been working with Regulatory Affairs in the Middle East for more than 25 years. She has a Pharmaceutical and Business background being a graduate of the Faculty of Pharmacy (Cairo University), RAC certified in addition to an MBA at...
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Dr Andrew Hewitt is a veterinarian with over 14 years of experience in Veterinary Medicinal Product development in a clinical and regulatory capacity. In his current position as Senior Advisor for Veterinary Product Development at knoell, Andrew...
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Rhydian Howells, associate director of regulatory affairs at Diamond Pharma services a Propharma group company. 20 years’ experience in the industry, 10 years at a large contract manufacturer developing manufacturing processes and analytical...
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Graham Howieson is a pharmaceutical business development consultant, inventor and entrepreneur. He is a highly experienced and competent leader, with an International pedigree covering UK, EU, USA and Asia. An industry pioneer with a forward...
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In 2003 David established PharmaDelivery Solutions Ltd as a specialised consultancy service in the field of drug delivery combination products (especially respiratory) device technology. This has led to involvement in projects with focus in...
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Jonathan Hughes, Ph.D., FTOPRA, has over 35 years of worldwide regulatory and clinical affairs experience across medical devices, drug / biologic – device combination products and in-vitro diagnostics. He has worked with medical device and...
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Salma Ismail is the CEO of Twinz Regulatory Affairs Pharmacist Consultants based in South Africa. Salma has over 25 years’ experience in the Pharmaceutical Industry and in Regulatory Affairs, which includes understanding of legislation,...
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Theresa Jeary holds a Master’s Degree in Pharmaceutical Science and is eligible to be a Pharmaceutical Qualified Person. Theresa has over 25 years’ experience working in both the Pharmaceutical and Medical Device industries and has worked in a...
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Dr David Jefferys is Senior Vice President for Global Regulatory, Government Relations, Public Affairs and Patient Safety (EMEA, Russia and Australasia) at Eisai. After qualifying, he worked in clinical and academic medicine before spending 20...
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Roger Joby: Director 1to1to1 Project Management Consultancy and Visiting Research Fellow Liverpool JM University An international pharmaceutical project management consultant and educator with over 40 years’ experience, principally for Clinical...
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Bi Jun is a pharmaceutical expert with more than 10 years of experience in health product development and registration in China. Currently in Knoell Shanghai, he is mainly responsible for regulatory support and the registration of pharmaceutical...
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Anne Jury is a regulatory affairs consultant with over 25 years experience in the medical and diagnostic healthcare products industries. With a degree in Microbiology, she went to work as company microbiologist for Smith & Nephew Textiles on...
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Adrian Keene is Director, Product Development Strategy at NAMSA, where he utilises his broad experience of changing EU medical device regulatory requirements to support clients worldwide. He was previously Head of Notified Body for the UK...
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Ben Kokx joined Philips in 2001 as a software designer. He quickly moved into a new role as a product security and privacy officer and worked as such in several business and market positions. As Director Product Security within the central...
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After more than a 30-year career in R&D for the pharmaceutical and medical diagnostics industry, Dmitriy started the D&L Consulting, Education and Services LLC in 2023. Prior to that, he spent 23 years developing PCR tests and platforms at Roche...
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Zuzanna Kwade is Software Clinical Evaluation Lead at Dedalus Healthcare. Zuzanna holds a PhD in Biochemistry and has 15 years of experience in clinical and medical research. She is the co-author of several white papers on regulatory aspects of...
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Graeme Ladds, Director of PharSafer, has over 30 years’ experience working in the pharmaceutical industry. Having started his career at Ashbourne Pharmaceuticals in 1989 as Head of Drug Safety & Medical Information, he went on to become Head of...
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Jane Leadsham is a IVD Medical Device professional with 10 years experience gained working in in vitro diagnostic Medical device development firstly for Novartis Pharmaceuticals, and currently as a consultant regulatory medical writer. Jane...
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Norah Lightowler is a partner in Lightowler Associates, an independent consultancy offering regulatory advice and support to pharmaceutical companies in or proposing to enter the European market for human pharmaceuticals. They are in their twenty...
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Ms. Siew Man Phang is a registered pharmacist in Malaysia, brings over 7 years ofpharmacovigilance and regulatory expertise. She has served as QPPV for multinationalpharmaceutical, generic, and distributor companies, gaining diverse experience...
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Mardon McFarlane is a co-founder of a consultancy, Taxo Bioscience, that specialises in supporting pre-clinical and clinical stage biotech companies, by ensuring they make the correct, impactful decisions early in their journey to bring...
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Joseph is a clinical trials specialist who has worked in laboratory and contract research organisations, and has led a clinical trials team for one of the world’s largest pharmaceutical companies. Joseph has a degree in Toxicology from Edinburgh...
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Dr Mel Munro has worked as a consultant in veterinary medicinal product development and registration for over 20 years. She provides regulatory advice on all areas of biologicals product development taking client projects from proof of concept...
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Makram Nehme is a Regional Regulatory Consultant having relevant experience with multiple multinationals including Parexel international, based in Lebanon. He has more than 10 years’ experience in the Pharmaceutical and Medical Device Industry...
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Cormac O'Prey is Principal and Director in the Kestrel Consultancy Group. He has experience in effective Business Development, Project Management and Product Development, with proven innovation capability. As part of the Kestrel...
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Declan O’Rourke has over 20 years’ experience in industry where he has held technical, marketing, product development, clinical development, production and pharmacovigilance roles.He is a veterinary surgeon, holds a Diploma in Marketing, a...
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Dr Adekunle Onadipe is an Associate Research Fellow in Bioprocess R&D, Cell Line Development at Pfizer Inc. USA. He leads a group of scientists responsible for the construction, development and characterization of mammalian and microbial cell...
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Linda Oyama is a microbiologist and lecturer at the School of Biological Sciences and Institute for Global Food Security, Queen’s University Belfast, with a first-class Microbiology degree and a PhD in Biological Sciences. Linda’s research...
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Paul R Palmer is a Director / Pharmaceutical Consultant and a practicing EU / UK Qualified Person. He has over 35 years experience in the pharmaceutical industry in the development, manufacture and supply of medicinal products and medical...
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Alina Panourgia is an experienced QA/PV Auditor and Regulatory Affairs professional, with a career spanning various regions. Alina started her career in SEA working at the manufacturing site leading Quality Control/Regulatory Affairs department....
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David Parry is a chemist with over 14 years of experience in in veterinary medicinal product development and registration. In his current position as CMC team leader at knoell, David works with manufacturers in developing formulations and the...
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Dr Ruchi Pathak Kaul is a TEDx Speaker and consultant to the Surgical Innovation Lab at All India Institute of Medical Sciences, New Delhi, where she runs the 3D printing lab and conducts research on medical devices developed using 3D printing...
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Karen Pearson has over 30 years’ experience of market research in the healthcare and business-to-business sectors. Karen started her market research career with IMS, providing market data to the European pharmaceutical sector, before moving on...
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Chris Penfold is an experienced Freelance Packaging Development Specialist and Consultant; a self-motivated, achievement oriented, confident and creative leader with a proven track record in general and technical management. He is a packaging...
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Dr David Petrick has over 30 years’ experience in bringing novel animal health products to the marketplace. During his professional career he has worked in Regulatory Affairs and Product Development for both American Cyanamid Company and...
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Dr John Price is a physician consultant in pharmacovigilance and regulatory affairs, working with several small biotechnology companies in North East USA planning submissions for marketing approval of oncology, haematology, renal and orphan...
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Ilona Putz is the founder and General Manager of PULONA Emerging Markets based in the UAE since 2008. Her company is dedicated to creating and developing tailor-made business concepts including regulatory consultancy for international...
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Cheryl is currently the Global Head of Medical Writing at BioMarin Pharmaceutical Inc., and specialises in medical writing for serious and life‑threatening rare diseases. She joined the pharmaceutical industry in 2001 in drug development, and...
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Dr. Andreas Rothmund is Qualified Person (retd) at Vetter Pharma-Fertigung in Ravensburg, Germany, an independent contract manufacturer specialised in the aseptic production of pre-filled application systems. He started his industrial career in...
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Ian Sealey graduated with a BEng (Hons) in Medical Engineering in 2003 and, after a taking a year out to study for a Graduate Diploma in Law, held health-related engineering and policy roles in the private sector, local government, and the...
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Lewis Shipp is a published pharmaceutical scientist and a recognised expert in drug development & manufacturing across a range of therapeutic modalities. Lewis currently works at the intersection of science & technology as a Digital CMC...
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Shaun Stapleton is an independent consultant providing regulatory strategy advice and support to biopharma clients globally. Shaun held positions of increasing responsibility in regulatory affairs at Sterling Winthrop, Eli Lilly, Boehringer...
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Anongrut (Mai) Surarutrungsri serves as the Regulatory Affairs Manager at Dr. Knoell Consult Thai. Her role encompasses several key responsibilities including Regulatory Intelligence, Monitoring changes in regulations, guidelines, and policies...
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Nikolaj Sørensen holds a MSc in biology and PhD in microbial ecology form the University of Copenhagen. He has worked with microbiomics for 10 years, both executing and leading laboratory and bioinformatic efforts, and has authored several papers...
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Donna is a University of Birmingham graduate with an honours degree in Biochemistry that included an industrial placement year at Celltech R&D, Slough (now UCB). Post-degree, Donna returned to Celltech as a Downstream Process Development...
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Greg Thay is the founder and principle human factors consultant at THAY Medical, and has over twenty years’ experience in the medical and pharmaceutical industries. He has worked in many therapy areas (orthopaedics, infusion therapy,...
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Pharmacovigilance Manager at Accestra Consulting Mr. Raphael Tian is a seasoned pharmacovigilance Manager at Accestra Consulting, with extensive experience in top global pharmaceutical companies and a focus on the Chinese market. With hands-on...
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Núria joined Bax as the Healthcare Innovation Team Lead in early 2024, bringing more than 20 years of experience across the bench-to-bedside pathway. With a multidisciplinary understanding of healthcare developed through roles in research,...
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Senior Regulatory Affairs Manager Ms. Wang is a senior regulatory affairs consultant specializing in the Chinese market with a Double Master’s Degree from Fudan University and Luiss Guido Carli University. She has in-depth understanding on...
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After obtaining a degree in Natural Sciences (Genetics) from Cambridge University (UK) and a PhD in molecular biology from Warwick University (UK), Philip joined Dehns in 1992. He is a qualified UK and European patent attorney, and a partner in...
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Jenny Webster began her role as Monitor of Veterinary Clinical Studies in 2013. Prior to that she was a Registered Veterinary Nurse (RVN) working in clinical practice in the UK. Jenny has actively monitored a range of GCPv studies in companion...
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Andrew Willis is an independent consultant providing expert advice and training on global regulatory solutions and pharmaceutical development. Previously, he worked for Catalent Pharma Solutions as VP Regulatory Affairs & Consulting Services,...
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Key positions held in career Programme Director Translucency Ltd Director of Operations Quintiles Consulting, specialising in medical device reimbursement Marketing Director Howmedica International (at the time a Pfizer company) manufacturing...
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RA & PV Director at Accestra Consulting Ms. Ye has been dedicated to regulatory affairs consulting for 15 years with a Pharmacy degree from Zhejiang University, China. She is experienced in regulatory compliance of China market access &...
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