Date(s) - 09/12/2019
12:30 pm - 5:30 pm BST
Hilton London Euston
On 12 September, NAMSA will present a half-day seminar dedicated to In Vitro Diagnostic (IVD) product registration and maintenance of CE Marks. Discussed will be information on how to proactively meet the challenges manufacturers face under the UK’s Brexit and the EU’s In Vitro Diagnostic Regulation (IVDR), the latter of which requires mandatory compliance by May 2022.
13:00-14:00: IVDR and Quality Management–The Fantastic 4 Systems or 1 System For All?
Presented by: Warren R. Jameson, PhD; Sr. Regulatory Consultant, NAMSA
Description: The IVDR clearly lays out that manufacturers must demonstrate performance, safety and possible risks/controls of products prior to availability within the European marketplace. With this requirement comes the reinforcement of four systems as described in the regulation. We will discuss the requirements in greater detail to ensure that your processes deliver a safe and reliable product that meets both the patient need and the compliance requirements under the new IVDR.
Key session takeaways:
- QMS: The need for development, feedback and what the requirements for IVDR compliance
- Risk Management and Vigilance: How the IVDR pushes risk management forward through ISO14971 harmonisation, and how to plan for data protection and other unrelated regulations (i.e., GDPR) under the IVDR (PRRC)
- Post-Market Surveillance and Performance Evaluations: How this has become a requirement and has expanded significantly within the IVDR, especially with self-declare analytical performance no longer an option
- The IVDR asks for the formation of the above systems, which is a significant aspect of compliance. From new start-ups to more mature business, organizations must take an intense look at QMS and make the appropriate changes to meet criteria
14:00-15:00: Brexit and IVDR
Presented by: Richard Bassett; Sr. Medical Writer, NAMSA
Description: As the uncertainty of Brexit continues to cloud the regulatory environment, it is important to understand the impact of this situation in the UK and how it may affect IVD regulations for manufacturers and Notified Bodies.
Key Session Takeaways:
- How does Brexit affect the IVD Regulations?
- Potential implications of ‘Hard Brexit’ and ‘Soft Brexit’ for IVD manufacturers
- How could Brexit affect Notified Bodies?
- How could Brexit affect the need for an Authorised Representative?
15:30-16:30: Implementation & Challenges of the IVDR–The Notified Body View
Presented by: Erica Conway; Global Head- IVD, BSI
Description: There are many changes that will come into effect with the IVDR for Operators, beginning May 2022. This presentation will provide an overview of the key challenges that are expected within the IVD sector, including the Notified Body view on where we are in the transition period.
Key Session Takeaways:
- Key differences of IVDR and MDR including classification, clinical evidence and conformity assessment of IVDs
- The designation process of Notified Bodies
- Challenges of the IVD sector and the Notified Body view on where we are in the transition period
16:30-17:30: Networking and Happy Hour
Regular Registration: £100.00 ($125.00 USD)
*** NAMSA reserves the right to cancel 1 week prior to event in the case of low attendance. A full refund will be honored should that happen. ***
- In Vitro Diagnostic Company Executives and CEOs
- Regulatory Affairs Professionals and Management
- Quality Professionals and Management
- R&D Engineers and Management
- IVD OEM and Suppliers
- EU Authorized Representatives
- Notified Body Representatives
|12:30 - 13:00 PM||Registration|
|13:00 - 16:30 PM||Program|
|16:30 - 17:30 PM||Networking Happy Hour|
|Warren has served as a Quality Manager ensuring compliance with relevant legislation (served as a qualified ISO9001:2015 auditor and Data protection Officer (GDPR)), managing quality documentation, risk assessments, risk management, and audits. Warren has experience in reviewing technical files and starting the transition from IVDD to IVDR. He also has over 5 years of experience in Research and Development including development of clinical quality controls for use in IVD machinery. His work covered regulatory documentation such as design initiation, design scope, design history, verification and validation of the project and transfer of product. Warren holds a Ph.D. in Molecular Biology investigating Haematology/Oncology and B.Sc. Hons in Molecular Biosciences with a Diploma in Industrial Studies. He furthered his experience and education by acquiring a certificate as an Internal ISO9001:2015 auditor.|
|Richard has supported regulatory strategies, served as the authorized representative, developed tech files, ensured MDSAP and EN ISO 13485 compliance and consulted on both MDR and IVDR upgrades of technical files to meet the new regulatory requirements for both medical device and IVD manufacturers. Additionally he has also completed Post Market Surveillance work including the PMS Reports and supporting the PMCF studies, trained clients on auditing towards ISO 13485:2016 and MDR and supported vigilance reporting and product registrations. Richard has also served a Medical Device Lead Assessor at BSI prior to joining NAMSA. Richard holds a LLM degree in Medical Law from Northumbria University, a MSc degree in Structural Molecular Biology from the University of London (Birkbeck College) and a BSc degree in Biomedical Science from Coventry University.|
|Erica has over 15 years experience in the In Vitro Diagnostic (IVD) medical device and pharmaceutical industries, within Regulatory Affairs and Quality Assurance. Following a BSc (Hons), PhD (Neurophysiology) and Post-doctural research, Erica’s industrial experience started at GlaxoSmithKline in the regulation of pharmaceuticals. Further she worked in the arena of clinical trials for medicinal products for Quintiles. Erica then moved into the field of IVD medical devices when she became the Regulatory Affairs Manager for Axis-Shield Diagnostics (Alere Toxicology). She then went into performing independent consultancy work and continued working within the IVD and medical device field, as a continued member of British IVD Association, prior to joining BSI. Erica joined BSI at the beginning of 2014 as a Technical Specialist/Scheme Manager in the IVD medical devices team. She took the position of Global Head of the IVD Medical Device Team June 2016, to lead the IVD Technical team. Erica is currently using her experience to transition the Notified Body (NB) to the new EU IVD Regulation and expand the technical team for the increased demands of the NB under the IVDR.|