Mai 13, 2019 - Mai 14, 2019
Date: May 13 & 14, 2019
Location: Brussels, Belgium
RAPS Regulatory Conference – Europe 2019 is the inaugural conference designed by European regulatory affairs professionals for European regulatory professionals. It’s where the regulatory community will gather to discuss the most pressing regulatory topics, share experiences and network with other stakeholders.
A wide range of current issues facing medical device, IVD and medicines regulatory professionals will be covered, as well as general subjects that impact all professionals in the healthcare products space.
Monday, 13 May 2019
Opening Joint Plenary Session: Thought Leader Discussion Panel – Regulatory Challenges
Panelists: Gert Bos, Qserve, Bassil Akra, TÜV SÜD Product Service GmbH, Oliver Bisazza, MedTech, Sabina L. Hoekstra-van den Bosch, Central Committee for Research Involving Human Subject (CCMO), Graeme Tunbridge, Medicines & Healthcare Products Regulatory Agency, and EMA, EU Competent Authority and European Commission invited.
Tuesday, 14 May 2019
Pharmaceutical Focused Session
How to Prepare for China Overseas Inspections
Session Leaders and Speakers: Gert W. Bos, Qserve and Zeli Yu, Yuzeli Medtecconsultant, Inc.
- Participants will be able to understand why a manufacturer might be selected to be inspected by NMPA.
- Participants will be able to understand how a manufacturer can prepare for inspections for a successful outcome.
- Participants will be able to review the necessary post-inspection activity that will enable them to respond to NMPA to avoid further regulatory action such as prohibiting imports.
Medical Device Regulation (MDR, Article 117): Impact on Pharma and Biotech Companies and State-of-Play
Session Leaders and Speakers: Beat U. Steffen, Confinis and Gert Bos, Qserve
Participants will understand how Article 117 influences their marketing authorization application for a drug-device combination product in Europe, understand the requirements set forth by regulators and notified bodies as well as how to practically address these requirements in their ongoing and upcoming development projects.
With offices in the USA, Europe, and China we are an essential partner for medical device manufacturers. With our global team of multilingual consultants, Qserve's expertise and experience provide international support, on a local level.