Developing the next generation of. regulatory affairs professionals: A. certified training programme. TOPRA Symposium 2017 Professional Development

Transcription

1 TOPRA Symposium 2017 Professional Development Developing the next generation of regulatory affairs professionals: A certified training programme Dr Samantha Alsbury, Head of Professional Development, TOPRA Michael Kipping, Group Manager Devices Safety and Surveillance, MHRA ENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSION

2 Agenda for the session 13:05 Samantha Alsbury Introduction 13:10 Michael Kipping MHRA perspective 13:25 13:30 Q & A

3 Medical Technology Regulatory Affairs A growing area with an unmet need for skilled staff A development programme to recognise commitment and progress Recruitment Retention An approach that can be used by other competent authorities. Medical Devices Medicines

4 MHRA Case study MHRA and TOPRA designed joint programme to meet MHRA learning need for devices TOPRA mapped MHRA requirements against current training offering TOPRA ran introductory meeting for the devices group covering professional development and the MTRA Certified programme A total of 20 MHRA devices staff have signed up to the MTRA Certified programme for 2017

5 Supporting your Regulatory Career Induction/EO/HEO/SEO/Meds assessors (Explore/Establish/Consolidate)

6 MTRA Certified 25 hours of training within two years A commitment to regulatory training tailored to learning needs: MTRA Certified Level 1 Examples: Foundation course, webinars MTRA Certified Level 2 Examples: Masterclasses, webinars TOPRA membership Attendance certificate for each course on completion. MTRA certified co-badged certificate on completion of the 25 hours including all reflective learning questions.

7 The process Identify the needs of staff Provide names of staff who will participate Staff book training via website and let us know Staff attend training and receive attendance certificate Staff complete CPD entry using CPD recorder Receive MTRA Certified certificate

8 MHRA perspective A career in regulatory affairs within medical devices/medicines can be extremely varied, intellectually stimulating and a rewarding path to follow. Life sciences is one of the five key pillars to the UK economy and vital to our prosperity. Enabling innovation within UK life sciences sector is essential for our health & prosperity The right environment for innovation is crucial - Economic & political stability - Access to appropriate manufacturing capability - Skilled workforce

9 MHRA perspective Appropriately trained regulatory staff are an essential foundation stone across the whole system Changes in the regulations (MDR / IVDR) bring new challenges and especially on the IVD side. This can be an opportunity or a threat depending on whether the UK has appropriately trained individuals. Opportunity to work together to develop learning & development opportunities that are widely understood and accepted by the broad range of employers in UK & beyond MHRA and TOPRA recognised that there was a gap in training of medical device regulatory professionals and worked together to develop the MTRA program

10 MHRA perspective MHRA medical devices operational capability It is our people who make the difference and add value Increasing need to grow our own staff We want to ensure that our staff are given the same opportunities to develop and that we are able to consistently train staff. Clear developmental milestones for staff that reflect the competencies we need Use of MTRA program as part of our staff development program and tool to attract staff to the agency. It is certain that all staff will leave at some point!

11 MHRA perspective Innovation Appropriate regulation can promote and accelerate innovation. Skilled regulatory staff are essential in the development of novel products Clear opportunity to enhance the training available in the UK to develop the regulatory network that can support and accelerate innovation. Innovation doesn t work in silos so linking networks and building ecosystems across different organisations is crucial Raising the profile of the profession is important and potential for development of Chartered status could be helpful

12 ENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSION