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RECOGNIZED COURSE QUALITY


DESIGNED FOR EXPERTS BY EXPERTS


MEDICINES PHARMACOVIGILANCE AND REGULATORY ASPECTS

PRE-MARKETING PHARMACOVIGILANCE LEGISLATION

This course aims to give you knowledge of pre-marketing pharmacovigilance legislation in the European Union.

This course firstly deals with the EU Regulatory framework governing drug safety during clinical trials (briefly mention FDA):

  • Definitions, Adverse Reaction Reporting (ICH E2A)
  • Overview of Good Clinical Practice

Then, with development Safety Update Reports (ICH E2F).

120 minutes
English
EUDRAVIGILANCE AND EVMPD

This course aims to give you a large knowledge and understanding of EudraVigilance.

60 minutes
English
INTERNATIONAL HARMONISATION INITIATIVES

This course intends to give you an understanding of the initiatives in place to promote harmonisation of Pharmacovigilance regulations and guidelines.

30 minutes
English
MATERIOVIGILANCE REGULATIONS

This course aims to give you knowledge and understanding of the regulatory environment concerning medical devices.

60 minutes
English
JAPANESE REGULATIONS

This course aims to give you understanding of the differences in regulations between Japan and the European Union.

120 minutes
English
CONTRACTUAL AGREEMENTS IN PV

This course aims to give you an overview of the need for types and use of Pharmacovigilance agreements and to provide an understanding of the contents of a Pharmacovigilance agreements.

90 minutes
English
GVP MODULE II - PHARMACOVIGILANCE SYSTEM MASTER FILE (PSMF)

The purpose of this course is to give you knowledge and expertise of the general philosophy of the European Guideline of the good pharmacoVigilance Practices (GVP), and particularly the objectives and the key concepts of the GVP module II called Pharmacovigilane System Master File (PSMF).

120 minutes
English
GVP MODULE IV - PV AUDITS

The purpose of this training is to enable you to know the general philosophy of the European Good pharmacoVigilance practices, and particularly the objectives and the key concepts of the GVP Module IV - Pharmacovigilance audits - Rev 1 (12 August 2015).

60 minutes
English
GVP MODULE VI - COLLECTION, MANAGEMENT AND SUBMISSION OF REPORTS OF SUSPECTED ADR TO MEDICINAL PRODUCTS

The purpose of this training is to enable you to better understand the new obligations of Marketing Authorisation Holder's (MAH's) on collection, management and submission of reports of suspected Adverse Reactions to Medicinal Products as described in GVP Module VI rev. 2 effective since 22nd of November 2017.

 

240 minutes
English
GVP MODULE VIII - POST-AUTORISATION SAFETY STUDIES (PASS)

The purpose of this course is to give you knowledge and expertise of the general philosophy of the European Guideline of the good pharmacoVigilance Practices (GVP), and particularly to better understand the new obligations of Marketing Authorisation Holders related to Post-Autorisation Safety Studies (PASS) by getting the objectives and the key concepts of the GVP Module VIII alone, plus Addendum I (Member States' requirements for transmission of information on non-interventional post-authorisation safety studies).

120 minutes
English
GVP MODULE XVI - RISK MINIMISATION MEASURES

This course on Risk Minimisation Measures aims to give you a better understanding of the new obligations of MAH’s towards EU Risk Management System regulation described in the GVP Module XVI–Risk minimisation measures: selection of tools and effectiveness indicators (rev2).

120 minutes
English
VALIDATION OF COMPUTERIZED SYSTEMS

The purpose of this course is to give you an overview of:

  • What is Computerized System Validation ?
  • Why is Computerized System Validation needed ?
  • What processes are needed for Computerized System Validation ?
60 minutes
English
POST-MARKETING PHARMACOVIGILANCE LEGISLATION

This course aims to give you a large knowledge of:

  • the Post-marketing Pharmacovigilance legislation in the EU e.i. the Pharmacovigilance Legal Tools, the marketing Authorisation Procedures
  • an overview of the European Guideline of the good pharmacoVigilance Practices (GVP) Module I, II, III, V, VI, VII, IX and X.
120 minutes
English
DEVELOPMENT SAFETY UPDATE REPORT (DSUR)

This course intends to familiarize you with the rationale, benefits, key aspects and process of writing Development Safety Update Reports.

60 minutes
English
VACCINES BIOLOGICS REGULATIONS

This course intends to give you knowledge and expertise in the different aspects of pharmacovigilance for vaccines and biologics. 

120 minutes
English
US REGULATIONS

This course aims to give you knowledge and expertise in the requirements for Pharmacovigilance in the European Union and in the United States, Pre-approval and Post-approval and the imminent changes in the European Union and in the United States. 

120 minutes
English
FRENCH REGULATIONS

Cette formation a pour but de vous sensibiliser à tous les éléments nouveaux liés au renforcement de la réglementation en matière de sécurité des médicaments soumis à autorisation de mise sur le marché et à la pharmacovigilance.

120 minutes
French
GVP MODULE I - PV SYSTEMS AND THEIR QUALITY SYSTEM

The purpose of this course is to enable you:

  • to know the general philosophy of the European Guideline of the good pharmacoVigilance Practices (GVP), and
  • to better understand the new obligations of Marketing Authorisation Holder's towards the quality system of the Pharmacovigilance system(s), GVP module I .
120 minutes
English
GVP MODULE III - PV INSPECTIONS

The purpose of this training is to provide you guidance described in the GVP Module III - Pharmacovigilance inspections :

  •  On the planning, conduct, reporting and follow-up of the pharmacovigilance inspections in the EU
  •  On the role of different parties involved
60 minutes
English
GVP MODULE V - RISK MANAGEMENT SYSTEM

The purpose of this training is to better understand the new obligations of Marketing Authorisation Holder's towards European Union Risk Management System regulation by getting the objectives and the key concepts of the GVP Module V in relation with the GVP module VIII and the GVP module XVI.

120 minutes
English
GVP MODULE VII - PERIODIC SAFETY UPDATE REPORT (PSUR)

The objective of this training is to enable you to better understand the obligations of MAH's on Periodic Safety Update Reports so often called PSUR as described in the GVP Module VII - Rev 1.

180 minutes
English
GVP MODULE IX - SIGNAL MANAGEMENT

The purpose of this course is to give you knowledge and expertise of the general philosophy of the European Guideline of the good pharmacoVigilance Practices (GVP), and particularly new obligations of Marketing Authorisation Holder's as described in the GVP Module IX called Signal Management.

60 minutes
English
SIGNAL DETECTION

This course intends to provide you an overview of pharmacovigilance signal detection, the methods used in, and the importance of safety signals.

90 minutes
English
MANAGEMENT AND REPORTING OF ADR

The purpose of this course is to give you

  • Knowledge and expertise of the classification of adverse reactions
  • Awareness of why having a knowledge of adverse drug reactions is central to pharmacovigilance
  • Understanding of the monitoring and evaluation of safety in clinical trials
  • Understanding of spontaneous reporting of ADRs and its strengths and weaknesses
240 minutes
English

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Short courses can be included in a training package for your team!


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