LOG IN OR SIGN UP TO "MY Eu2P"MEDICINES PHARMACOVIGILANCE AND REGULATORY ASPECTS
PRE-MARKETING PHARMACOVIGILANCE LEGISLATION
Make good use of the pre-marketing pharmacovigilance legislation in the EU and beyond
POST-MARKETING PHARMACOVIGILANCE LEGISLATION
Learn how to implement the post-marketing pharmacovigilance legislation in the EU and of key GVP modules
EUDRAVIGILANCE AND EVMPD
Make the most of EudraVigilance and its recent changes
DEVELOPMENT SAFETY UPDATE REPORT (DSUR)
Write accurate Development Safety Update Reports
INTERNATIONAL HARMONISATION INITIATIVES
Grasp the concepts of the international initiatives to promote harmonisation of Pharmacovigilance regulations and guidelines
GUIDELINES FOR GOOD PHARMACOEPIDEMIOLOGY PRACTICES
Get a clear view and be confident in your Good Pharmacoepidemiology Practices
VACCINES BIOLOGICS REGULATIONS
Become an expert in pharmacovigilance for vaccines and biologics
DEVICE VIGILANCE AND SURVEILLANCE
Be aware of the regulatory environment concerning medical devices
US REGULATIONS
Quickly grasp the pre- and post-approval regulations in US
JAPANESE REGULATIONS
Know more about the pre- and post-approval regulations in Japan
FRENCH REGULATIONS
Sensibilisez vous à la réglementation en matière de sécurité des médicaments soumis à autorisation
CONTRACTUAL AGREEMENTS IN PV
Have a good knowledge of Pharmacovigilance agreements types and use
CANADIAN PHARMACOVIGILANCE REGULATIONS
Quickly grasp the pre- and post-approval regulations in Canada
GVP MODULE I - PHARMACOVIGILANCE QUALITY MANAGEMENT SYSTEM
Become an expert in the obligations of Marketing Authorisation Holder's towards the quality system of the Pharmacovigilance system(s), GVP module I
GVP MODULE II - PHARMACOVIGILANCE SYSTEM MASTER FILE (PSMF)
Learn all about the Pharmacovigilane System Master File (PSMF), GVP module II
GVP MODULE III - PV INSPECTIONS
Catch how to plan, conduct, report and follow-up the pharmacovigilance inspections in the EU, GVP module III
GVP MODULE IV - PV AUDITS
Master the key concepts of the Pharmacovigilance audits, GVP module IV
GVP MODULE V - RISK MANAGEMENT SYSTEM
Know all about the obligations of MAH on European Union Risk Management System regulation, GVP module V
GVP MODULE VI - COLLECTION, MANAGEMENT AND SUBMISSION OF REPORTS OF SUSPECTED ADR TO MEDICINAL PRODUCTS
Know all about the obligations of MAH on collection, management and submission of reports of suspected ADR, GVP module VI
GVP MODULE VII - PERIODIC SAFETY UPDATE REPORT (PSUR)
Get expert in the reviewing and writing of the Periodic Safety Update Reports (PSURS), GVP module VII
GVP MODULE VIII - POST-AUTORISATION SAFETY STUDIES (PASS)
Master the obligations of MAH related to Post-Autorisation Safety Studies (PASS), GVP module VIII
GVP MODULE IX - SIGNAL MANAGEMENT
Know all about the obligations of MAH on signal management process, GVP module IX
GVP MODULE XVI - RISK MINIMISATION MEASURES
Know all of the obligations of MAH on EU Risk Management System regulation , GVP module XVI
SIGNAL DETECTION
Quickly grasp the pharmacovigilance signal detection concepts, the methods used in, and the importance of safety signals
VALIDATION OF COMPUTERIZED SYSTEMS
Be familiar with the validation process of computerized systems as well as the responsibilities & Standard Operating Protocols
MANAGEMENT AND REPORTING OF ADR
Quickly grasp the risk perception concepts and guidance to take into account for EMA, ICH E2E and CHMP
GESTIÓN Y NOTIFICACIÓN DE RAM
Entienda rápidamente los conceptos de percepción del riesgo y las orientaciones a tener en cuenta para la EMA, la ICH E2E y el CMH
RISK MANAGEMENT PLANS AND EUROPEAN UNION REGULATORY PERSPECTIVE
Know how to monitor and evaluate of safety in clinical trials including spontaneous reporting of ADRs
PRINCIPLES OF LABELING AND SUMMARY OF PRODUCT CHARACTERISTICS (SMPC)
Become an expert in the product labelling process including IB and SmPC
ROLE OF THE QUALIFIED PERSON RESPONSIBLE FOR PHARMACOVIGILANCE (QPPV)
Clearly identify the central role of the qualified person responsible for Pharmacovigilance (QPPV)
