There are three main components of the GPPC.
ISoP and IPV Standards
Institute of Pharmacovigilance is developing
standards for pharmacovigilance professionals. These describe Career and Competence framework and will be available soon.
Following documents are currently in the development. Please, have a look and submit your comments via email.
Stage of Development
Global Professional Pharmacovigilance Certification (GPPC)
Career Framework defines roles and seniority steps in pharmacovigilance profession. This describes our essential understanding of what types of jobs and career ladders are there in the industry, universities, and regulatory authorities, that one can consider for their career development.
Defines the required knowledge, skills and attitudes expected for the positions defined in the Career Framework.
This informs all education and training providers, as well as the members of the profession and candidates for certification about what competence they need to achieve to improve what they do and elevate their career.
Professional Certification is testing competence of candidates against the expectations defined in the first two steps above. Candidates may apply for a certification in particular role and seniority step. They would be required to submit documentation to satisfy admission criteria, then pass the specific test, behavioral interview and oral exam.
Successful candidates will receive the certificate. Certificate holders would be required to ensure they keep their competent current, and potentially subject to regular re-certification, or even better, progress to the certification of the next seniority level.
- Definition of roles and seniority in pharmacovigilance career
- September 2021 (draft version)
- Publication in 1Q 2022
- Definition of required knowledge, skills and attitudes for a role and seniority
- December 2021 (1st role standard)
- Publication 4Q 2021
- Testing Competence of candidates for a particular role and seniority
- December 2021 (Pilot)
- 1Q 2022 - 1st role standard and seniority certification in production
- 4Q 2022 - all defined roles and seniorities certifications in production
Delivery of the first educational courses in Pharmacovigilance
Start of the collaboration with the ISoP SIG on Career Framework in Pharmacovigilance
Organisation of the first common seminar with ISoP, called ISoP Prague Seminar
Work with ISoP Advisory Board and Executive Committee on preparatory work of Global Pharmacovigilance Professional Certification (GPPC) program
Selection of Web Design partners and exploratory talks with certification providers
First role and seniority survey launched
Collection of the test questions launched
ISoP Strategy and Concept paper regarding GPPC approved for ISoP membership consultation
Terms of Reference for Scientific Board approved by the Executive Committee for ISoP membership consultation
First draft of Career Framework guideline published for consultation
Draft of Career Framework Guideline 0.2 published for consultation
The pilot of the GPPC project has been approved by ISoP members at ISoP General assembly.
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