Select a region
North America Europe Asia
Key Regulatory Topics: The eCTD 2014 RAPS: The Regulatory Convergence RAPS Learning Solutions RAPS Store - The source for regulatory knowledge RAPS Executive Development
Key Regulatory Topics: The eCTD
2014 RAPS: The Regulatory Convergence
RAPS Learning Solutions
RAPS Store - The source for regulatory knowledge
RAPS Executive Development

RAPS & Regulatory

RAPS is the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. Founded in 1976, RAPS helped establish the regulatory profession and continues to actively support the professional and lead the profession as a neutral, non-lobbying nonprofit organization. Read more »

 Upcoming Events
Event: Chapter

Chapter Event
Using Regulatory Intelligence in Regulatory Strategy
15 April 2014 | Indianapolis, IN

Event: Chapter

Chapter Event
Medical Device Regulatory Update
17 April 2014 | Austin, TX

Event: Webcast

Webcast
Utilizing Critical Security Controls to Secure Healthcare Technology
23 April 2014 | Online

Event: Advertising, Promotion and Labeling: the US Regulated Environment

Virtual Program
Advertising, Promotion and Labeling: the US Regulated Environment
30 April 2014 | Online

Event: RAPS Executive Development

Workshop
RAPS Executive Development
2–5 June 2014 | Evanston, IL

Event: 2014 RAPS: The Regulatory Convergence

Conference
2014 RAPS: The Regulatory Convergence
27 September–1 October 2014 | Austin, TX


» View more events

 Community
Join the discussion -- RAPS Regulatory Exchange

QP(Qualified Person) Qualification
Posted: 4/16/2014 5:20:00 AM
From : Discussion Post>>Regulatory Open Forum
Hello all, I am looking for some clarification on the qualifications of QP (Qualified Person) in EU Member States. The Article 49 of the Directive 2001/83 (a link to the directive here ) outlines the qualifications and necessary ...

RE:RAC certification benefit in Europe
Posted: 4/16/2014 2:57:52 AM
From : Discussion Post>>Regulatory Open Forum
Dear Aiste, apologies for my late reply, but I still wanted to comment on your question regarding your company's potential lack of support for the RAC recertification. There are in fact so many ways in which you can earn recertifica...

RE:MR Compatibility
Posted: 4/15/2014 12:40:01 PM
From : Discussion Post>>Regulatory Open Forum
Paul, 1.5 Telsa - currently the most common 3 Telsa - becoming popular Putting "MR-conditional" constitutes or should be interpreted to constitute a significant change to the labeling. Thus, it would require a new 510(k) submiss...

Become a Member


Regulatory Focus Online

Regulatory Focus Breaking global regulatory news and in-depth expert insight.

Read Regulatory Focus »

In the RAPS Store

RAPS The source for regulatory knowledgeThe source for regulatory knowledge.
RAC prep resources, Books, RAPS Online University courses, on-demand webcasts and more.

View more »