PSMF is a legal requirement globally for the companies having their Pharmacovigilance system in place. The PSMF provide an overview of the pharmacovigilance system within a company, and supporting and documenting compliance. The content of the pharmacovigilance system master file should reflect global availability of safety information for medicinal products authorized in the country, with information on the pharmacovigilance system not just confined to local or regional activities.
At the conclusion of this tutorial, participants should be able to:
- Discuss the content of Pharmacovigilance System Master File
- Describe how to create and maintain a PSMF so that it can be available on request from regulatory authorities
- Overcome challenges on preparation and maintenance of PSMF
If you are involved in any aspect of pharmacovigilance and looking forward to strengthen your pharmacovigilance knowledge, this WEBINAR will help you to increase your knowledge base regarding the techniques and regulatory processes involved in creation and maintenance of Pharmacovigilance Master File.
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.
- Understanding Pharmacovigilance system and regulatory expectations
- Introduction to Pharmacovigilance system Master File
- PSMF Format and Layouts
- Creating an effective PSMF file
- PSMF maintenance
- Do’s and Don’ts with PSMF
- QA Session
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 are 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