Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at raps@raps.org if you need assistance.
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.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
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.
Convergence 2020 has come and gone, but you can still access recorded sessions, which are available to attendees until 31 December 2020.
This year, our European regulatory community will converge online with a fully virtual program that will allow attendees to experience Euro Convergence live online from the safety and comfort of their homes.
RAPS' “how to” guide to developing a comprehensive global regulatory strategy for all types of medical devices. Updated September 2020.
The last exam window of 2020 is currently open. Register by 8 October to take the RAC exam this autumn.
The site navigation utilizes arrow, enter, escape, and space bar key commands. Left and right arrows move across top level links and expand / close menus in sub levels. Up and Down arrows will open main level menus and toggle through sub tier links. Enter and space open menus and escape closes them as well. Tab will move on to the next part of the site rather than go through menu items.
RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.
Posted 21 October 2016 | By Zachary Brennan
The European Commission on Friday opened a consultation to consider the views of a number of different stakeholders on the future of health technology assessments (HTAs) across the EU member states.
The commission is looking to track the experiences in the current system and the on-going cooperation mechanisms, as well as any future needs and opinions on the proposed approach in the Inception Impact Assessment.
Specifically, the EC is looking to hear more on a number of issues, including: The extent and impact of the current diversity of the national HTA system, the scope for joint work on the EU level, its use in national decision-making and feasibility, as well as studies that are being launched to support the impact assessment with data.
The EC says the initiative will not affect national pricing and reimbursement decision but to “communicate consistently from the outset that areas of price-setting and reimbursement should clearly remain national responsibility in line with Article 168 (7) of the Treaty on the Functioning of the European Union (TFEU) and are not covered by any future initiative on HTA.”
Speaking Friday at the EC-EUnetHTA Forum in Brussels, Vytenis Andriukaitis, EC Commissioner for Health and Food Safety, said: "The commission has supported voluntary cooperation on HTA for more than 20 years, we have built a solid knowledge based on methodologies and information exchange. Now it is time to take the next step: to build a permanent, sustainable mechanism for EU cooperation on HTA so that all member states can benefit from the added value created by pooling resources, exchanging expertise and avoiding duplication in the assessment of the same product or intervention."
The consultation will run until 13 January 2017, after which a consultation report will be finalized. In parallel, the commission has launched a number of studies to further analyze possible options for HTAs.
Consultation
Stakeholder Consultation Strategy: Strengthening of the EU cooperation on Health Technology Assessment (HTA)
Tags: HTA cooperation, health technology assessment
Regulatory Focus newsletters
All the biggest regulatory news and happenings.