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May 8, 2023

The Schlafender Hase Team

Regulatory Affairs – Partnering for Knowledge

The regulatory environment is both complex and subject to constant change. It is crucial for a regulatory affairs professional to keep up-to-date while interfacing with both project teams and regulatory authorities to achieve their primary goal; to ensure compliance throughout the product cycle, from drug development through to marketing approval and post-approval updates, as new information becomes available or regulations are updated.

As a company that was built around a specific need for Regulatory Affairs (RA), we must also remain on top of regulatory developments. Ensuring our software continues to meet the needs of RA professionals. Our top resource is RAPS, the Regulatory Affairs Professionals Society and in this article we look at our partnership with RAPS and the importance of this organization.  

Building your Regulatory Affairs Network

Given the nature of the job, this makes it important to maintain strong networks, and to exchange knowledge both within a company and its functions, and crucially, with other RA professionals and RA professional societies. The largest of these societies is the Regulatory Affairs Professionals Society (RAPS).

What is the organization of regulatory affairs professionals?

RAPS was founded in 1976 and is a neutral, non-profit organization that supports RA professionals through “education and training, professional standards, publications, research, networking, career development, and other valuable resources.” [1] Its headquarters are in Washington DC, with chapters and affiliates throughout the world. It has approximately 30,000 members in over 100 countries, and also provides Regulatory Affairs Certification (RAC) credentials on knowledge and expertise in RA. 

How does RAPS serve the RA community? Is RAC certification worth it?

RAPS serves the RA community by providing a range of learning materials and opportunities for RA professionals to interact. It helps keep professionals up to date on changes affecting healthcare product regulation by proactively addressing “evolving regulatory competencies.”[2] And it promotes the profession itself, helping to ensure that the pharmaceutical industry has the qualified people it needs. 

It does this, for example, by promoting RA communities and networks live and online, as well as with online and face-to-face learning, and through various programs, and events. Events or programs can range from meet and greets through to webcasts and in-person programs with RAC credits, to name just a few.

Premium Solutions Partner

For a company like Schlafender Hase, the importance of RAPS and its scope of activities make membership invaluable. For that reason, Schlafender Hase is a RAPS “Premium Solutions Partner”. [3] This gives us access to the range of quality resources RAPS provides, and we can contribute by working together with RAPS to provide education to it’s members. 

Schlafender Hase attends RAPS events to  learn from the regulatory affairs community and engage with RA professionals and the healthcare industry as a whole. For instance, we regularly participate in the annual RAPS Convergence events, the next of which are being held in May 2023 (EU) and October 2023 (NA) [4].

No RA professional is an island. And nor is “the rabbit”, because we see engaging with customers, RA professionals and the life science industry as the best way to keep abreast of regulatory developments affecting the industry and ensure TVT meets our customers’ needs.

  2. ibid

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