Medical Devices

Tina Amini

Presenter

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...

Stuart Angell

Presenter

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...

Janette Benaddi

Presenter

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...

Gregory Berman

Presenter

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,...

Will Burton

Presenter

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...

Dale Charlton

Presenter

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...

Philip Clay

Presenter

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...

Koen Cobbaert

Presenter

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...

Nancy Consterdine

Presenter

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,

Richard Featherstone

Presenter

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...

Barbara Grossman

Presenter

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...

Anna Harrington-Morozova

Presenter

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...

Heba Hashem

Presenter

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...

Graham Howieson

Presenter

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...

David Howlett

Presenter

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

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...

Rob Hughes

Rob Hughes has worked in the pharmaceutical industry for more than 35 years. Rob started his career in control laboratories before gaining accreditation as a “Qualified Person”. During his career, he has held operational,...

Jonathan Hughes

Presenter

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...

Theresa Jeary

Presenter

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...

David Jefferys

Presenter

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...

Adrian Keene

Presenter

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...

Michelle Kelly

Presenter

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...

Ben Kokx

Presenter

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...

Zuzanna Kwade

Presenter

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...

Graeme Ladds

Presenter

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...

Gerry McGregor

Presenter

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,...

Rona Middlemiss

Presenter

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...

Cormac O'Prey

Presenter

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...

Mary-Ann Preston

Presenter

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...

Ilona Putz

Presenter

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...

Irene Rossi

Presenter

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...

Andreas Rothmund

Presenter

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...

Paul Shields

Presenter

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,...

Jag Shur

Presenter

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...

Paul Sim

Paul Sim, Regulatory Affairs Manager, BSi Group. Paul has worked in the healthcare industry for 34 years and is currently Project Managing BSI’s implementation of EU Commission Recommendation 2013/473/EU dealing with Unannounced Audits. Joining...

Julie Suman

Presenter

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...

Greg Thay

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,...

Jeremy Tinkler

Presenter

Jeremy Tinkler, Director, Regulatory Consultancy & QA, MedPass International, Responsibilitiesinclude: Regulatory & clinical strategy, adverse event assessment & reporting, regulatory consultancy (strategic planning, clinical evaluation,...

Christopher Waterhouse

Presenter

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...

Paula Wittels

Presenter

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...