GET CERTIFIED IN DRUG SAFETY


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, provides a brief overview of relevant FDA regulations

 And finally, describes Safety Update Reports (ICH E2F)

120 minutes
English
200 €
EUDRAVIGILANCE AND EVMPD

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

60 minutes
English
Free course
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
Free course
MATERIOVIGILANCE REGULATIONS

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

60 minutes
English
100 €
JAPANESE REGULATIONS

This course will bring you knowledge and understanding of Japanese pharmacovigilance regulations and guidelines. A comparison to EU and US legislation and practices is also provided.

Emphasis is placed on the problems of interpretation of pharmacovigilance regulations both pre- and post-authorisation.

120 minutes
English
200 €
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
150 €
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
200 €
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
100 €
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
400 €
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
200 €
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
200 €
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
Free course
RISK MANAGEMENT PLANS AND EUROPEAN UNION REGULATORY PERSPECTIVE

This course aims to introduce the different aspects to take into account as philosophical aspects, risk perception concepts but also guidance to take into account as Risk Management Plan for European Medicines Agency, International Committee Harmonization E2E, Committee for Human Medicinal Product guidance and new legislation.

120 minutes
English
200 €
ROLE OF THE QUALIFIED PERSON RESPONSIBLE FOR PHARMACOVIGILANCE (QPPV)

The objective of this course is to present you the legal framework that governs pharmacovigilance and the central role of the QPPV in pharmacovigilance practice.

The lecture includes a brief discussion of all vigilances.

180 minutes
English
300 €
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
200 €
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
100 €
VACCINES BIOLOGICS REGULATIONS

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

60 minutes
English
100 €
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
200 €
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
200 €
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
200 €
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
100 €
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
200 €
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
300 €
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
100 €
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
150 €
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
400 €
PRINCIPLES OF LABELLING

The objective of this course is to provide you with an overview of the safety communication processes and the safety risk management approach, including the safety label change process.

You will also

  •  Develop an awareness of safety data and its influence and impact on product labelling
  •  Develop knowledge and understanding of the practical implications of European regulations and guidance concerning labelling
  •  Understand the principles determining the content of the Investigator Brochure (IB) and Summary of Product Characteristics (SmPC)
  •  Become familiar with analysis and management of an emerging risk by amendments to product labelling
180 minutes
English
300 €

COMPANIES OFFER

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


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