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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.
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.
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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.
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Helen Brooke Taussig: An Often Overlooked Advocate for Drug Safety
11 October 2019
Are the periodic safety update reports a useful pharmacovigilance tool in the EU?
10 October 2019
Regulatory Strategies for EU MDR and EU IVDR Implementation
03 October 2019
What is Sufficient Clinical Evidence According to the MDR?
02 October 2019
Implementation of Shared MDR Economic Operator Resources
01 October 2019
What EU MDR Means for Substance-Based Medical Devices
30 September 2019
Contingency Plans for MDR and IVDR Implementation for a no Deal Brexit
20 September 2019
Impact of Regulation 2017/745 (MDR) on the Relationship Between Medical Device Manufacturers and Their Suppliers and Subcontractors
19 September 2019
Breaking Down UDI Questions
18 September 2019
Challenges in Clinical Evaluation for the EU Versus China
17 September 2019
Postmarket Surveillance and Postmarket Clinical Follow-up
12 September 2019
04 September 2019
18 October 2019
17 October 2019
17 October 2019
15 October 2019