Embedded Files
Course 1 : Pharmacovigilance Systems Master File (PSMF)
Date : 28th and 29th September, 2019
Duration : 5 hours
Time : 4.30 pm to 7 pm IST on both days (GMT +5.30 hours)
Mode of training : Online LIVE
Course Fee : 80 USD (including complete training material and certificate)
Course type : Training on basics, regulations, best practices with standard case studies illustrating common errors, pitfalls, regulatory findings or comments.
Course Background : The PSMF is the starting point of inspection by the agencies, usually the first document requested by inspectors when companies are notified about the inspection
The PSMF provide an overview of the pharmacovigilance system within a company. It’s a modular document that should be regularly updated. The contents of the pharmacovigilance system master file provide global availability of safety information on company’s products.
Why it’s important to always maintain your PSMF in good shape?
Significant proportion of Major findings and the largest proportion of minor findings are in relation to the PSMF
A well drafted PSMF provides a good overview of the PV systems to the inspectors, thereby facilitating the inspection and reducing the stress of the inspection on both parties.
Course Content : This training will provide valuable assistance and technique to the pharmacovigilance team members who are involved in writing and maintaining PSMF, as well as team members responsible for compliance, audits and contributing data to PSMF. Candidates will learn about the format and layout of Pharmacovigilance system Master File, how to create and maintain an effective PSMF; common inspection finding around PSMF and key dos and don’ts with PSMF to ensure regulatory compliance.
This training will help participants to overcome challenges on preparation, regular update and long-term maintenance of PSMF.
Format & layout of PSMF
How to create and maintain and effective PSMF
Common Inspection findings around PSMF
Key dos and don’ts with PSMF to ensure regulatory compliance
Please send the filled up registration form to admin@scientiabio.com to register and call us at +91 804169 2453 / +91 9945318216 for any query or registration help.
Course 2 : Writing Risk Management Plans & Drafting Efficient Risk Minimisation Measures
Date : 19th and 20th October, 2019
Duration : 5 hours
Mode of training : Online LIVE
Course Fee : 80 USD (including complete training material and certificate)
Course type : Training on basics, regulations, best practices with standard case studies illustrating common errors, pitfalls, regulatory findings or comments.
Course Background : In the EU and in many other countries, all companies are required to provide risk management plans (RMPs) for every new product. RMPs are also required for generic products. Risk minimization measures must be accurately presented in the RMPs. Additional Pharmacovigilance activities and/or additional risk minimization measures are required for new products, and almost always required for biosimilars and hybrid applications. In addition, there may be requirements for modified RMPs throughout the lifecycle of a product.
Course Content : This course aims to familiarize participants with EU template of RMP, common comments received from assessors, discuss routine and additional tools for managing product risks, how the effectiveness of a selected RMM is assessed, and points to consider for the modification, revision, or release of a given additional RMM. Course also includes practical advice on measures to be taken to achieve regulatory compliance.
EU template of RMP- key points
Common comments received from assessors
Routine and additional tools for managing product risk
Assessing the effectiveness of a selected risk minimization measure
Points to consider for the modification, revision, or release of a given additional RMM.
Please send the filled up registration form to admin@scientiabio.com to register and call us at +91 804169 2453 / +91 9945318216 for any query or registration help.
Course 3 : Global literature search management
Date : October, 2019
Duration : 5 hours
Mode of training : Online LIVE
Course Fee : 80 USD (including complete training material and certificate)
Please send the filled up registration form to admin@scientiabio.com to register and call us at +91 804169 2453 / +91 9945318216 for any query or registration help.
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