Program Inclusions
- 24x7 Online access to Learning Management System – Presentations ( PPTs), Notes, Session Recordings
- Audio Video Session Recording - 2 hours
- Online MCQ Exam
- Certification - Cliniminds USA ACCRE Accreditation
Fee- ₹5,000 + 18% GST
International Fee- US $199
Program Details :
- Regulatory Framework Overview
- QPPV Roles and Responsibilities
- Legal Requirements for QPPVs
- Pharmacovigilance System Master File (PSMF)
- Risk Management Plans (RMP)
- Signal Management
- Periodic Safety Update Reports (PSURs)
- Adverse Event Reporting
- Pharmacovigilance Audits and Inspections
- Post-Authorization Safety Studies (PASS)
- Communication with Regulatory Authorities
- Quality Management System (QMS)
- Training and Education for Pharmacovigilance Staff
- Data Privacy and Confidentiality
- Brexit Implications for QPPVs
- Challenges in Pharmacovigilance
- Future Trends in Pharmacovigilance
- Responsibilities of MAH towards QPPV
- Frequent QPPV Inspection Findings by EMA
- Pharmacovigilance Compliance Management
- QPPV Communication with Regulatory Affairs
- QPPV Communication with Quality Assurance
- QPPV Communication with Internal and External Stakeholders
- Inspection of the MAH and QPPV Role
- QPPV Role in Quality Assurance Internal Audits
Qualified Person for Pharmacovigilance (QPPV)
A Qualified Person for Pharmacovigilance (QPPV) plays a critical role in ensuring the safety and efficacy of pharmaceutical products. The QPPV is responsible for establishing and maintaining the pharmacovigilance system, ensuring compliance with regulatory requirements, and overseeing the collection and reporting of safety data. In the U.K., Europe and in GCC Countries regulatory requirements mandate that companies have a designated QPPV to manage pharmacovigilance activities. The role of QPPV is also important in other countries, including the U.S., Canada, Australia, India and Japan, where robust pharmacovigilance systems are critical for regulatory compliance.
Cliniminds – Leaders in Skilling and transforming professionals since 2004
Cliniminds today is the global leader in the life sciences sector skilling and professional training. Cliniminds has alumni of 11,500+ professionals. Cliniminds has worked with over 200+ pharmaceutical companies, CROs, medical device companies and IT consulting firms on variety of life sciences sector training and workforce solutions. Some global clients include Oracle, Stryker, Novartis, WHO and many more. Cliniminds programs are Accredited by Life Sciences Sector Skill Development Council, a Sector Skill Council, set up by National Skill Development Corporation (NSDC) along with Industry Representatives. LSSSDC is an approved & recognized Vocational Education Awarding Body by National Council of Vocational Education and Training (NCVET), and working under aegis of Ministry of Skill Development & Entrepreneurship (MSDE).
For more information, please feel free to contact us at +91 9560102589
You may also write to us at info@cliniminds.com
