Good Pharmacovigilance Practice GVP

GVP-001:The Focus of PharmacoVigilance as an integrated risk-benefit evaluation

Online Training Id: GVP-001

Geographical Region: International

Level: Intermediate

This course gives an overview about the legal background of Pharmacovigilance regulation, and will review the new regulations for Good Vigilance Practice, the PharmacoVigilance System, Master file, and the duties & responsibilities of the Qualified person (PhV).

Learning Objectives:

The presenter will review the NEW regulations relevant to Pharmacovigilance systems in Europe and the actions necessary to prepare the Pharmacovigilance System Master File (PSMF).

Author:

Dr. Boris Borissov MD  CLINICAL RESEARCH –PHARMACOVIGILANCE

 

 

 

 

 

Dr Borislav Borissov MD, is the former Executive Director (1998 to 2004) of the Bulgarian Health Authority and was responsible for all interactions with the EU Commission, EMEA, CADREAC, WHO and EU competent authorities.  He is an expert dealing with the highly prescriptive requirements of the EU Regulatory Authorities and the FDA for Pharmacovigilance.  He is a registered SME in Europe and EudraVigilance user with who is a Qualified Person for Pharmacovigilance for XEVMPD and E2B reporting. 

He has extensive experience developing and executing clinical trial protocols, medical writing, consultation, and project management.  He has conducted or been involved in many scientific assessments with the competent authorities (CAs) in Europe.  An expert in the development of the  eCTD for submission in EU and Middle East; he has a conducted many Regulatory, Good Clinical Practice and Pharmacovigilance training programs in throughout Europe including Serbia, Bosnia as the UK, Greece, Switzerland, and in the  in Middle East.  He is fluent in English, French, and Russian.

GVP-002: What you need to know about the new PharmacoVigilance Regulations

Online Training Id: GVP-001

This course gives an overview about the legal background of Pharmacovigilance regulation, and will review the new regulations for Good Vigilance Practice, the PharmacoVigilance System, Master file, and the duties & responsibilities of the Qualified person.

Learning Objectives:

The presenter will review the NEW regulations relevant to Pharmacovigilance systems in Europe and the actions necessary to prepare the Pharmacovigilance System Master File (PSMF).

Author:

Dr. Axel Thiele  PHARMACOVIGILANCE COMPLIANCE AUDITING

 

 

 

 

ChemistFormer Direktor and Professor at Federal Institute for Drugs and Medical DevicesHead of Unit Risk Management Procedures and Pharmacovigilance Inspections Since 1981- Employee at Institute of Drugs of the Federal Health Authority / Federal Institute for Drugs and Medical Devices at the Department Post Marketing Surveillance / Pharmacovigilance Since 1986 - Head of Unit Risk Management Procedures, Pharmacovigilance Inspections since 2014 - Consultant Senior Expert Pharmacovigilance

GVP-003:How to survive a PharmacoVigilance regulatory Inspection

Online Training Id: GVP-003

Geographical Region: Global

Level: Intermediate

This course gives an overview about the legal background of a Pharmacovigilance Inspection, the preparation of the company in the forefront of the inspection (“inspection readiness”) and the procedure of the inspection by the Regularity authority.

Learning Objectives:

The presenter will highlight the more common issues of noncompliance in PHV regulations and will detail the actions necessary to prepare for a GVP.

 

Author:

Dr. Axel Thiele  PHARMACOVIGILANCE COMPLIANCE AUDITING

 

 

 

 

ChemistFormer Direktor and Professor at Federal Institute for Drugs and Medical DevicesHead of Unit Risk Management Procedures and Pharmacovigilance Inspections Since 1981- Employee at Institute of Drugs of the Federal Health Authority / Federal Institute for Drugs and Medical Devices at the Department Post Marketing Surveillance / Pharmacovigilance Since 1986 - Head of Unit Risk Management Procedures, Pharmacovigilance Inspections since 2014 - Consultant Senior Expert Pharmacovigilance

This Package Includes:

  1. The Focus of PharmacoVigilance as an integrated risk-benefit evaluation [Watch a Demo]

  2. What you need to know about the new PharmacoVigilance Regulations [Watch a Demo]

  3. How to survive a PharmacoVigilance regulatory Inspection  [Watch a Demo]

GBP 75.00
GBP 75.00
GBP 75.00

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