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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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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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Justin is a Senior Consultant at ONIX and has worked within the industry for over 11 years. He has a background in Submission Management, working for pharmaceutical companies and a Regulatory Operations software vendor. Justin provides ONIX...
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Dr Glyn Belcher has over 25 years experience in clinical development and drug safety in the pharmaceutical industry. He qualified in medicine from Oxford and Cambridge and received his PhD in neuropharmacology from the latter university. After a...
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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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Gregory is Head of the Medical Group at Kinneir Dufort, an award-winning research, innovation, design and product development company, with over 30 years’ experience helping companies discover, create, develop and realise tangible new products,...
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Maikel Bouman works as a Senior Regulatory Operations Manager at Qdossier and in his role he has a strong focus on managing Regulatory Operations, coordination, and development of staff; planning and coordination of projects, including regulatory...
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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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Will Burton, Director of Russell Square Quality Representatives (RSQR) Ltd, is engaged in providing a range of consultancy and training services to the international medical device, pharmaceutical and biotechnology industry sectors. Prior to...
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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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Jasbir Chohan is the Founder and CEO of ONIX and has over 19 years in the pharmaceutical industry. Jasbir started the company in 2010 and has established a worldwide customer base. In 2013, Jasbir was selected for the Business Management...
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Philip is Director and Principal Toxicologist with Chorley Consulting. He is a UK and European registered toxicologist and specialises in product safety assessment with over 30 years experience in toxicology and safety assessment. He is a BSI...
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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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Nancy Consterdine is a joint director in her 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,
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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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Rocío Duchén (MSc) is a chemist, with experience in research, technical translation and consulting. Rocío has worked in research fields including biochemistry, natural products and food additives, as well as in the development and validation of...
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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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Marc Feary is Principal Scientist at Lonza. He has greater than 15 years’ experience in biopharmaceutical development and bioproduction, having held R&D and commercially-focused roles at Lonza Biologics facilities in Slough and Cambridge (UK). ...
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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 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 2016, a...
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Shelley is currently using her regulatory experience to work with the pharmaceutical industry to ensure they implement the new pharmacovigilance legislation. Shelley is part of the NDA Group AB and previously was with the MHRA (UK Regulatory...
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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 the Head of Science and Technology at Sobi AG, based in Geneva, Switzerland. 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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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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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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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...
Eamonn Hoxey, is a technical author, trainer and consultant in life science areas including regulatory compliance, quality management, sterility assurance and standards development. Eamonn worked for Johnson & Johnson for 17 years in positions of...
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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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Caroline Idowu (MChem) is a chemist by background and has been working at Pen & Tec Consulting since 2019. During her time at Pen & Tec and her current role as Regulatory Manager, she has been involved in a wide range of projects along each stage...
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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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Dr Seema Jaitly qualified in Medicine from Charing Cross and Westminster Medical School in 1992 and worked in hospital medicine for four years. She has worked in the pharma industry for over 18 years at CROs and companies spanning clinical...
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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...
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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...
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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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Michelle Kelly is Biological Safety Manager for MHRA devices. She has worked for the agency since 2008 and current responsibilities include principal lead on all clinical trial applications for biological safety, provide expert biological safety...
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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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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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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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After a Ph.D and postdoctoral positions in the UK and USA in protein biochemistry Peter joined Celltech (now part of UCB Pharma). There he was involved in biologics discovery. His next relevant position was with Roche where he became a senior...
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Mercia Lucouw works as a regulatory affairs associate at Qdossier, a Celegence company.She provides regulatory support to a variety of pharmaceutical companies.Mercia holds a bachelor degree in pharmacy (B.Pharm) from the North West University,
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Sara Magalhães works as Regulatory Affairs Consultant at Qdossier, a Celegence company. She provides regulatory affairs consultancy and services to both big- and small-sized pharmaceutical companies, covering a wide variety of products. Sara...
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Pharmacovigilance Manager at Pharma To Market Ms. Priyanka Mangle is a Pharmacist with Master’s degree in pharmacy and post-graduate diploma in clinical research. She is an experienced Pharmacovigilance professional with hands-on experience in...
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Mardon McFarlane is an Associate Director in the External Manufacturing group at CRISPR Therapeutics and is responsible for the relationship management and overall governance of an external global network of CDMOs (contract development &...
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Gerry McGregor received his PhD in at Imperial College London, before taking up a post-doctoral position at the Max Planck Institute of experimental medicine in Göttingen, Germany. During several years in medical research at Marburg University,...
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Rona is a Senior Safety Assessor with Chorley Consulting. She holds a first class MSci in Biomedical Sciences from the University of Aberdeen and is a member of the Royal Society of Biology. Additionally she has attended a training course on the...
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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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Senior Regulatory Affairs Manager at Accestra Consulting Mr. Ng is based in China with almost a decade of regulatory affairs experience of the Chinese market with a Master’s Degree from the University of Nottingham. He has extensive knowledge...
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Peter O’Callaghan holds BSc and PhD degrees in Genetics from Newcastle University. Since graduation he has gained over 10 years’experience in biotechnology research and development in academia and industry, during which time he co-authored...
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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 Consultancy...
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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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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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John Parkinson is a Data and Pharmaco-epidemiology Consultant. He previously worked as Director of the Clinical Practice Research Datalink (CPRD) at the MHRA, which developed out of the General Practice Research Database (GPRD) and NIHR Research...
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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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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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Mary-Ann Preston is the EMEA manager for medical writing services at NAMSA, a medical research organization providing full-service support throughout the product development process for medical devices, diagnostics, and combination...
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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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Irene Rossi is the Head of New Modalities Pharmaceutical Development at Nanopharm, an Aptar Company (UK). Irene obtained a MSc in Pharmaceutical Chemistry and Technology in 2014 and a PhD in Drugs, Biomolecules and Health Products at the Food 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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Joanne Roza works as a senior regulatory affairs consultant at Qdossier. She is involved in regulatory affairs consultancy and has also expertise in regulatory operations for big- and small-sized pharmaceutical companies. Joanne holds a bachelor...
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Saad Shakir is a pharmacoepidemiologist and drug safety physician. He has worked in the fields of pharmacovigilance, pharmacoepidemiology and risk management for 30 years, initially at the UK Regulatory Authority, then the international...
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Dr. Shields holds a Ph.D. in Biochemistry from the University of Pennsylvania and a B.S. in Chemical Engineering from the University of Michigan. He has 33 years of experience in process development and manufacturing of APIs and drug products,...
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Dr Shur is an academic and entrepreneur having over 100 published scientific papers and was CEO of Nanopharm Ltd, which he led to a successful exit in 2019. Jag’s main area of research and commercial endeavour is in the complex topical...
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Dr Sanjeev Srivastav, Director of PV Signal, is a highly analytical and quality-focused healthcare professional with over 20 years experience in Clinical Medicine, Pharmaceuticals and Health administration. He provides safety consultation on PV...
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Dr. Julie D. Suman is the Vice President of Scientific Affairs for Aptar Pharma. She manages strategic scientific planning and Aptar’s Scientific Advisory Board. Dr. Suman is also the co-founder of Next Breath. She holds a B.S. in Pharmacy from...
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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...
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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Jeremy Tinkler, Director, Regulatory Consultancy & QA, MedPass International, Responsibilitiesinclude: Regulatory & clinical strategy, adverse event assessment & reporting, regulatory consultancy (strategic planning, clinical evaluation,...
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Hans van Bruggen is CEO of and Senior Regulatory Affairs Scientist at Qdossier. He holds an MSc. in Pharmaceutical Medicine from the University of Surrey (UK) and has worked in the pharmaceutical industry for more than 35 years, primarily at...
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Marloes van der Geer works as senior regulatory affairs scientist at Qdossier. Marloes holds a master in Life Sciences (Drug Innovation) from the University of Utrecht, the Netherlands. For nine years she held several positions at Hoffmann-la...
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James holds a PhD in Medicine from the University of Manchester, Masters in Clinical Genetics from the University of Sheffield, Chartered Linguist status from the Chartered Institute of Linguists, and the European Medical Writers Association Nick...
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Chris Waterhouse is Managing Director of iDi Pac Ltd, a member of the Packaging Collective Leadership team as well as a former Chairman of the UK Packaging Society.Chris has over 30 years’ experience in the Packaging Industry having worked in a...
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Dr. Philip Webber obtained his first degree from Cambridge University, UK (Natural Sciences, Genetics) and then carried out research on the regulation of brain-specific genes at Warwick University, UK, where he obtained his PhD. He qualified as a...
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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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Nick Wills is a regulatory affairs advisor with over 10 years of experience in Veterinary Biologics development in a regulatory and quality assurance capacity. In his current position as an Advisor for Veterinary Product Development at knoell...
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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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Senior consultant at Accestra Consulting Ms. Marylene Zhan is a senior consultant at Accestra Consulting with extensive experience in pharmacovigilance and regulatory affairs, with a Master's Degree from the Zhongnan University of Economics and...
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