Imperial College White City Incubator is pleased to invite you to the workshop Upcoming regulatory challenges facing medical devices and pharma: what SMEs need to know
The Medical Device Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR) are new EU rules which will become enforceable in May 2020 and May 2022 respectively. The 2014 Clinical Trials Regulation (CTR) is now expected to be implemented around the same time as the MDR, in May 2020.
The MDR and IVDR are intended to further improve patient safety with respect to medical devices and in-vitro diagnostic products within the European Union. The CTR aims to harmonise and streamline the regulatory process for managing clinical trials within the EU.
This workshop for SMEs will provide guidance on the nature and scope of the new regulations and how your business can comply.
MDR and IVDR apply to all medical device, pharmaceutical and in-vitro diagnostic product businesses that sell products within the European Union. The CTR and the associated changes to GMP legislation will eventually apply to all clinical trials conducted within the EU but the implementation has been hampered by delays in the construction of the EMA’s communications portal. The impact of Brexit on both medical devices and medicinal products moving between the EU 27 and the UK is also still uncertain.
Who should attend the workshop?
It is important for start-ups to understand the new regulations as it will enable them to put in policies and procedures now, which will make them compliant and remain as the companies grow.
This workshop will be of interest to people working for companies who are developing medical devices, IVDs or medicinal products for supply to the EU or the UK.
What is contained within the new medical device and IVD regulations and why they are necessary
What will be different once the Clinical Trial Regulation is implemented and how Brexit is expected to impact the conduct of trials in both the EU and UK.
Cost of participation
This module is dedicated to small and medium-sized enterprises and participation is free of charge.
The presenters are regulatory experts from NSF Health Sciences, part of NSF International, a not-for-profit organization dedicated to improving human health:
Howard Broadbridge, BSc, DMS
Practice Manager – NSF Health Sciences
Howard has over 30 years’ experience of working in the medical device industry in various commercial roles across multiple sectors, with companies such as Johnson & Johnson, Welch Allyn and Optos. He has initiated and led several high-profile new product launches in the fields of medical consumables, ophthalmology and surgical instruments. Since joining NSF, Howard has been active in helping companies to understand the MDR and IVDR, how they can prepare for the changes and achieve a smooth transition.
Dr Peter Gough, Hon. DSc, MSc, CSci, CChem, FRSC, FCQI, CQP
Executive Director, Pharma-Biotech, NSF Health Sciences
Peter has over 40 years’ experience of pharmaceutical manufacture, control and quality management. In 2016 he was awarded an honorary Doctor of Science degree by Kingston University, London, for services to pharmaceutical quality management.
He held numerous positions at Eli Lilly over a 30-year career, culminating in the role of Senior Quality Consultant in Eli Lilly’s Global Quality Systems division before he joined NSF in 2005. He is an expert in pharmaceutical law as it applies to the manufacture of medicinal products and has extensive experience of defining quality systems at a global level. He is a former member of the European Federation of Pharmaceutical Industry Association’s (EFPIA) Manufacturing and GMP ad hoc group and was EFPIA topic leader on the ICH Expert Working Group which prepared the Q9 guideline on Quality Risk Management
Peter has an extensive knowledge of the role of the Qualified Person (QP), having been eligible to act as a QP since 1985 and a past chairman of the Royal Society of Chemistry’s Qualified Person Assessor panel. He is a Fellow of the Royal Society of Chemistry and of the UK Chartered Quality Institute (CQI) and a former chairman of the CQI’s Pharmaceutical Quality Group.