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This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Event Date: Tuesday, 8 September 4:00 PM – 5.15 PM CET
Register By: 7 September, 2022
Member: € 0
Nonmember: € 25
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Regulatory Affairs (RA) & Quality Assurance (QA/QMS) are business enablers for start-ups and existing Pharmaceutical, Biotech, and Medtech (incl. IVD) companies by ensuring adequate regulatory compliance and market access for in-house developed products. RA & QA are also of critical importance to support company or product acquisitions by assessing and evaluating available data. Any regulatory gaps in such data, or any gaps in the QA/QMS processes applied during the generation of such data, could potentially diminish the value of the data which could risk or prolong market access with potential financial impact. Therefore, smart Pharma, Biotech, and Medtech companies include RA & QA in the core team of their Due Diligence (DD) process to increase the financial predictability of M&A business transactions.
The expertise of RA to assess the regulatory value of the available data, and the expertise of QA/QMS to assess any gaps in the Quality processes applied during the generation of such data, is one of the USPs of RA and QA/QMS. On the buyer’s side, RA & QA will support the buyer’s interests by critically evaluating the available data and the QA/QMS processes applied. On the seller’s side, the RA and QA expertise is needed to present and defend the value of the data generated, the adequacy of the QA/QMS processes applied, and the feasibility of the company or product roadmap with its QA and RA milestones.
Members: €0 | NonMembers: €25
With this webcast you will learn how to approach a DD situation from the RA & QA/QMS point of view of the buying company and from the point of view of the selling company that wants to be acquired or to sell a product or its IP.
You will learn how to guide the situation from both sides. Furthermore, you will learn to see the situation from a financial perspective and with this understand the critical information that RA & QA need to provide to the DD core team such that the DD Core team can present a substantiated recommendation/advice to the CEO or the board of directors on the business transaction under consideration.
Basic: Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher level activities.
This webcast is available to global regulatory professionals.
Susana (VP RAQA Ypsomed):
Example RAQA check-list: here acquisition of SW for medical device
Rainer (Director RAQACA Cairdac):
Start-up with one unique medical device, being acquired: RAQA roadmap
Eric (RAQA consultant):
Example RAQA check-list for pharma acquisition
Patrik SPIRIG ( CFO KONApharma):
Financial considerations pharma acquisition
Susana de Azevedo
Susana de Azevedo Wäsch is a biotechnologist and vice president of quality management and regulatory affairs with Ypsomed AG. She has more than 18 years of experience in medical devices, pharmaceuticals and biotechnology. Wäsch is experienced in the areas of regenerative medicine, implants, drug-device combination products and infusion pumps. Prior to Ypsomed, she worked at Geistlich Pharma AG, Switzerland; Eidgenössische Technische Hochschule Zürich; Lonza Visp, Switzerland; the European Bioinformatics Institute, Cambridge, England; and the Center for Advanced Research in Biotechnology in Rockville, MD, USA. After earning her MSc at the Ecole Supérieure de Biotechnologie Strasbourg, France, she performed her dissertation at the Institute of Microbiology at the Swiss Federal Institute of Technology in Zurich, followed by further training at the Executive School of Management, Technology and Law in St. Gallen, Switzerland.
Rainer Voelksen is director RA/QA of CAIRDAC, the first company in the world to successfully develop a self-sustainable pacemaker pledging over 15 years of lifespan. He has 30 years of experience in regulatory, including running his own regulatory consulting firm. Prior to launching his company, Voelksen was with MicroPort CRM as director of regulatory affairs and regulatory intelligence. He spent several years as project manager at the Swiss Federal Office of Public Health, working to implement the MDR and IVDR into Swiss law. He has served in regulatory and leadership roles at Swissmedic, the Swiss competent authority for therapeutic products, Australia’s Therapeutic Goods Administration, and medical technology and biotech companies in Europe and Australia. Voelksen is a RAPS Fellow and served as chairman of RAPS’ board of directors.
Life-Sciences RA & QA
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