PCRAProfessional Certification in Regulatory Affairs
A professional credential offered by EUSTM Academy, an educational initiative of the European Society for Translational Medicine (EUSTM) — recognising professionals with demonstrated expertise in navigating the regulatory requirements for medicines and medical technologies, from marketing authorisation and submissions to lifecycle maintenance and compliance across international frameworks.
Awarded by the EUSTM Academy — an educational initiative of the European Society for Translational Medicine (EUSTM), a non-profit scientific society registered in Vienna, Austria (ZVR 629427022), active in more than 60 countries since 2013.
Certification Benefits
The EUSTM Academy Professional Certification in Regulatory Affairs provides a structured way to demonstrate your knowledge, experience and professional contribution in this specialist area. As a certified professional, you can:
EUSTM Academy certification is designed to strengthen professional positioning and provide evidence of assessed competence. Recognition and acceptance remain subject to the independent requirements of employers, institutions, regulators and other professional bodies.
Who Should Apply?
PCRA is designed for professionals actively involved in the regulation of medicines and medical technologies — across industry, clinical, and consultancy settings. If one of these describes you, you are eligible to apply:
- Regulatory-affairs associates, officers, and managers
- Professionals moving into regulatory affairs from R&D, QA, or clinical roles
- Pharmacists, life scientists, and clinicians entering regulatory work
- Medical-device and IVD regulatory professionals (EU MDR/IVDR)
- CRO and regulatory-consultancy staff
- QA and pharmacovigilance professionals with regulatory responsibilities
- Regulatory operations and submissions-publishing specialists
- Public-health and policy professionals working with regulatory frameworks
Application process
Applying is straightforward. Complete the secure PCRA application form and upload your CV — your submission goes directly to the EUSTM Academy Educational Board.
The Board reviews every application and assigns one of two pathways based on your background and experience. Category 1, the Professional Experience Pathway, is a CV- and experience-based evaluation for established professionals — no examination required. Category 2, the Examination Pathway, is for those earlier in their career or moving into the field, with certification granted on passing a qualifying online examination (results within two weeks). If you are unsure which applies, the Board assigns your category after reviewing your application.
Once your pathway is confirmed, you sign the Certification Conditions Form and pay the applicable fee. Your PCRA certificate is then issued, together with the right to use the post-nominal title.
PCRA Certification Fee
| Category | Initial Fee | Renewal |
|---|---|---|
| High- & middle-income countries | €350 | €300 / year |
| Low-income countries | €250 | €200 / year |
Country tiers follow the World Bank income classification. Annual renewal confirms your continued active engagement in regulatory affairs and your commitment to the EUSTM Code of Professional Conduct.
Begin your PCRA certification journey
Apply in minutes — complete the form and upload your CV — to begin your formal recognition as a certified regulatory affairs professional.
Start Your ApplicationFor further information, please contact the EUSTM Academy at [email protected].
Disclaimer: PCRA is an independent professional certification awarded by the EUSTM Academy, the education division of EUSTM. It is a non-statutory professional-society credential and is not an academic degree or state-regulated qualification, and is granted following individual assessment by the EUSTM Academy Educational Board through either the Professional Experience Pathway or the Examination Pathway.