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The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
Resources, news and special offers to support you and your professional development during this difficult time.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
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Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Download your copy of the new events calendar and see all the online workshops, conferences, RAC exams and European online workshops RAPS has planned for 2021 at a glance.
Registration is now open for RAPS Euro Convergence 2021! Attend to join peers from EU and around the world to gain insights and exchange ideas on the regions most pressing issues.
An invaluable resource for any professional engaged in designing, composing, compiling, or commenting on regulatory documentation
From self-assessments to help you identify your strengths and areas to focus on to reference books and online courses that will help you fill in the gaps in your regulatory knowledge, RAPS has the resources to help you prepare for the RAC exam.
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The goal of the workshop is to provide participants with strategies and tools for substantiation of compliance with the General Safety and Performance Requirements (GSPRs) of the EU Medical Devices Regulation (MDR) Annex I by application of international standards. The workshop is interactive, and participants will work hands-on on practical cases. Facilitators and instructors will be notified body experts, consultants, medical device manufacturers and independent laboratory experts.
The workshop will consist of:
6/23/2020 -8/14/2020: Early Bird $400 Member | $500.00 Nonmember
8/15/2020 – August 29 2020 Regular $500.00 Member | $600.00 Nonmember
Objectives
Click here to download the agenda
Speakers
Dr. Bassil Akra is CEO and one of the owners of the QUNIQUE GmbH, a medical device and in-vitro diagnostic consultancy company, located in Germany and Switzerland. He spent the last decade as a subject matter expert at the biggest notified body in Europe and represented locally and the globally the notified body association in the various European discussion. Dr. Akra was the Vice President for strategic business development at the Global Medical Health Services of TÜV SÜD Product Service GmbH in Germany. He has long experience in leadership, business management, research, development, quality management and regulatory approval of medical devices, combination devices and ATMP products. Dr. Akra played an essential role during the implementation of the medical device regulation (MDR 2017/745) in Europe and was involved in the drafting of the several European guidance documents (e.g. MEDDEV, MDCG, etc.). He spent the last years of his career at TÜV SÜD training and educating the various stakeholders on the EU Legislations (e.g. MDD/AIMDD, MDR and IVDR) and their impact on the EU healthcare system.
Sabina Hoekstra is founder and principal of EUMD Consultancy, specializing in regulatory advice to the health products industry. Sabina has 20 years of experience as pharmaceutical and medical device regulator in the Dutch government, serving subsequently in the Medicines Evaluation Board, Ministry of Health and CCMO (governmental organization for clinical investigations). She has represented the Netherlands and EU in several in several international working groups. She has worked as Lead for European Regulation in Philips, where she acted as leader and expert in European Medical Device and Pharmaceutical Regulations and Standards on corporate level. She was involved in Philips’ EU MDR/IVDR Implementation Program. She was Vice-Chair of the EU Regulatory Affairs Focus Group and Chair of the Clinical Working Group in COCIR and Member of Regulatory Affairs Committee in MedTech Europe. Sabina has a long track record as volunteer in global professional organizations (DIA and RAPS) and she is a regular speaker and faculty member in educational conferences on regulatory topics. Sabina was co-founder and chair of RAPS Netherlands Chapter and chair of the RAPS European Council (REC). She is Fellow of RAPS and staring 2020 she will serve in the RAPS Board of Directors.
Martin Witte is Global Director for the Focus Teams Active Implantable and Cardiovascular Devices, in his current role Martin is leading an international team of experts and auditor providing conformity assessment services on high risk medical devices. Additionally Martin is leading the local team for active implantable medical devices at TÜV SÜD Product Service in Munich. Martin started working with TÜV SÜD in Feb. 2014 and had prior to that a role as Regulatory Affairs Manager in BIOTRONIK, Berlin focusing on Defibrillatory, Pacemakers, MR Conditional devices and leads. This role he had for 6 years and prior to starting in industry Martin studied Biomedical Engineering in Hamburg.
Dr Peter W Bowness, Technical Team Manager with responsibility for devices utilising materials of animal and human origin, IVF/ART and organ preservation joined the British Standards Institution in 2012 from industry, after leading projects to develop mesh and injectable collagen implants for guided tissue regeneration and soft tissue reinforcement and bulking in clinical areas such as hernia repair, abdominal wall reconstruction, breast reconstruction, fistula, obesity and soft tissue deformity. Previous experience includes management of GMP stability and drug release testing for recombinant antibody therapeutics. Dr Bowness is technical specialist conducting conformity assessments for devices utilising materials of animal origin, surgical implants and surgical instruments and is Chair of the British Standards technical committee for symbols and labelling in medical devices and a member of the UK technical committee for risk management in medical devices.
Andreas Purde studied electrical engineering in Munich. After some time in the automotive semiconductor industry he went back to university working in the field of optical surface measurement. He started at TÜV SÜD 14 years ago as auditor and test engineer for functional safety - he now leads the German departments for active medical devices.
Cancellation Policy: All cancellation requests must be submitted in writing to raps@raps.org. RAPS is unable to accept cancellations by phone. Please specify the name of the person registered and event title. Should you need to cancel your registration, you can apply your credit to any RAPS program for the next 12 months. Substitutions may be accepted with written approval from RAPS and must be submitted to raps@raps.org. RAPS will allow substitutions up to the first day of the event.
Program Contact
Stephany Evans Meeting and Events Specialist Regulatory Affairs Professionals Society® Tel: 301 770 2920, ext. 229 5635 Fishers Lane, Suite 400, Rockville, MD 20852 USA