QPPV stands for Qualified Person Responsible for Pharmacovigilance and is a Qualified and experienced professional in all aspects of Pharmacovigilance. QPPV is the main person responsible for handling the Marketing Authorization Holder’s (MAH) Pharmacovigilance system effectively and ensuring the system meet the regulatory obligations in regards to the safety monitoring of the products.
QPPV is required in Pharmacovigilance system as per the legal obligations in EU per GVP Module I which states that “all marketing authorization holders to have one qualified person for pharmacovigilance (QPPV) with responsibility for establishing and maintaining all aspects of the company’s global pharmacovigilance system.” The QPPV is responsible for all Pharmacovigilance related activities like risk management including detection, assessment, understanding and communication of safety information. QPPV acts as a single point of contact for the Competent Authorities for inspections and other communication on a 24-hour basis
At the conclusion of this training, participants should be able to:
- Handle the QPPV responsibilities in regards to Pharmacovigilance system management
- Create and maintain a Pharmacovigilance system to make it Inspection Ready for regulatory authorities
- Overcome challenges in maintenance of the Pharmacovigilance system
If you are already working as QPPV and want to raise your competency standards or looking forward to starting your professional journey as QPPV and looking forward to strengthening your pharmacovigilance management skills, this training will help you to increase your knowledge base regarding the techniques and regulatory processes involved in creation and maintenance of Pharmacovigilance system.
This will be a perfect learning opportunity in all areas of drug safety, pharmacovigilance, regulatory and quality compliance and will be a great addition to your knowledge in pharmacovigilance.
Please note: online access is for 8 weeks.
- Regulatory aspects of Pharmacovigilance
- Good Pharmacovigilance Practices and Ethical Principles
- QPPV and EUDRAVIGIANCE registrations
- Regulatory and Legal Requirements in Pharmacovigilance
- Pharmacovigilance System management
- Pharmacovigilance Operation Management
- Pharmacovigilance Risk Management and related activities
- Safety Monitoring & Signal Detection
- Pharmacovigilance IT system and Validation
- Pharmacovigilance Audits and Inspections
- Pharmacovigilance Compliance Management
- Quality Control (QC) and Quality Assurance (QA)
- Pharmacovigilance System Documentations
- Pharmacovigilance System Metrics & KPIs Tracking
- Pharmacovigilance Training Management
- Pharmacovigilance Agreements
- Regulatory Reporting
- Pharmacovigilance Communication and Reporting
- Documentation and Record Keeping
- Analytical skills and Decision Making
- Communication and Information Management
- Workload Management
Academy of Clinical Intelligence
Sunil has been in the Clinical Research Industry for over 10 years. He held the position of Director of Trainings for a leading Contract Research Organization, HAROM Solutions. His company facilitates the business sector by providing Pharmacovigilance services to Pharmaceutical companies and technical trainings to Medicine, Dental, and Pharmacy, Life Science professionals internationally in the fields of Pharmacovigilance, Clinical Research, and Medical Writing etc. He has been involved in trainings throughout his career particularly in the areas of Pharmacovigilance including ARGUS Safety, Clinical Research and Medical Writing. With over 10 years of experience in the pharmaceutical industry and clinical research organization, Sunil offers his clients the assurance that their drug safety training programs are being conducted by a seasoned pharmacovigilance executive with experience in developing, implementing and leading safety trainings in lower cost markets.
Sunil was formerly Manager, Trainings & Operations of Clinical Research and Pharmacovigilance, where he successfully developed and led more than 8 therapeutic area teams and support training and operations functions for the management of Clinical Data and Adverse Event reporting for human health, including all phases of a product life cycle (drugs, vaccines and devices). Sunil is a client certified trainer with expertise in techno-functional training on Oracle Argus Safety 7.0 including Argus activities, User management, Case processing including duplicate check, case book-in, follow up, coding, medical review, reports generating (Expedited, Aggregated, PSUR) and dashboard reports. He ahs proficiency in WHO-DD and MedDRA Dictionary and knowledgeable in various regulatory guidelines like ICH guidelines, Good Clinical Practices, Good Documentation Practices and Volume 9A etc.
All Professionals involved in:
- Pharmacovigilance (including QPPV)
- Clinical Research
- Risk Management
- Drug Safety Assessment Department
- Safety Data Analysis
- Information Technology
- Regulatory Affairs
- Pharmacovigilance consultancy
- Quality and Compliance