PSMF Online Training - A Technical Training Program on Creating and Maintaining Pharmacovigilance System Master File (PSMF)


Training
Academy of Clinical Intelligence
ID: 5769505

Today there is a large number of companies implementing the Pharmacovigilance System Master File as per the requirement of regulatory authorities.

As per the Pharmacovigilance Inspection Metrics Report for the period April 2016 - March 2017, the major findings were observed in relation with:

PSMF content
Deficiencies in the maintenance of the PSMF and Article 57 Database
The largest proportion of minor findings was in relation to the PSMF

PSMF is a legal requirement globally for companies having their Pharmacovigilance system in place. The PSMF provides an overview of the pharmacovigilance system within a company, and supporting and documenting compliance. The content of the pharmacovigilance system master file should reflect the 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.

Learning Objectives:

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 to make it INSPECTION READY for regulatory authorities
Overcome challenges in preparation and maintenance of PSMF

If you are starting up your Pharmacovigilance System or facing challenges in maintaining your PSMF and looking forward to strengtheninyour pharmacovigilance knowledge in regards to PSMF, this TRAINING will help you to increase your knowledge base regarding the techniques and regulatory processes involved in the 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.

Course Content

Introduction and History of PSMF
PSMF Regulations and Countries
PSMF Structure - Core Sections & Annexes
Creating a PSMF
Creating Core Section 1 - QPPV and Annex A
Creating Core Section 2 - Organizational Structure and Annex B
Creating Core Section 3 - Sources of safety data and Annex C
Creating Core Section 4 - Computerized Systems and databases and Annex D
Creating Core Section 5 - Pharmacovigilance Processes and Annex E
Creating Core Section 6 - Pharmacovigilance system performance and Annex F
Creating Core Section 7 - Quality System and Annex G
Creating Core Section 8 - Change control, logbook, versions, and archiving and Annex I
Creating Annex H
Creating SOP on PSMF
EU - Location, registration, and maintenance
Pharmacovigilance System Master File Location (PSMFL) code
Initial submission of Pharmacovigilance System Master File (PSMF) information
Requesting a single/multiple PSMF EV Code(s)
Maintenance of a Pharmacovigilance System Master File Location (PSMFL) entity
Change of PSMF information
Notifying a PSMFL entity as 'non-current'
PSMF and Article 57 XEVMPD content and maintenance
Submission of PSMFL information
Submission of different PSMFs at the same location
Intended use of PSMFL information
Pharmacovigilance System Master File (PSMF) number
Timelines for submission of a PSMF
PSMFL within an AMP entity
Sharing a PSMFL EV Code between organizations
Notifications of QPPV details/PSMF location via Article 57 Database
Correction of information within a PSMFL entity
Update of an AMP entity to include PSMFL information
Update of PSMFL information referenced in an AMP
Update of PSMFL information following a variation/renewal
Nullification of PSMFL entity in the XEVMPD
Management of deviations and implementation of the associated CAPAs listed in the Pharmacovigilance System Master File (PSMF)
PSMF real-time scenarios for effective learning
Q&A

Course Provider

Sunil Verma,
Director ,
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.