Certificate course including the latest updates and an online assessment
- ICSR reporting in detail
- PV quality and compliance management
- Contracts in pharmacovigilance
- EudraVigilance: New signal management
- The risk management plan (RMP) after Revision II of GVP Module V
- Risk minimisation measures: Dos and dont's
Aims and objectivesPharmacovigilance in Europe is subject to constant change. This is why even advanced pharmacovigilance practitioners must always keep up to date with the latest developments and broaden their horizons in order to gain a proper overview of the current requirements for drug safety.
This training course provides you with comprehensive know-how of the latest developments in drug safety. A concluding online multiple-choice test after the course serves to check your understanding of the content and round off the intensive two days.
Benefit from our experts' extensive knowledge and learn how to critically scrutinise and optimise current workflows in your as well as other departments.
The number of participants is limited to 15 in order to ensure that there is sufficient time for questions and discussion.
(08:30 registration on day 1)
- XEVMPD, IDMP, EVPM, EVCTM, EudraVigilance: Properly understanding the correlation
- EMA Roadmap
- Appropriate adverse reaction reporting - changes in the new reporting format ICH E2B (R3)
- Experiences and challenges with EudraVigilance and ICH E2B (R3)
- Technical implementation options
11:15 Coffee break
- Pharmacovigilance system requirements and responsibilities
- Quality objectives in pharmacovigilance
- Critical pharmacovigilance processes and business continuity
- Practical exercise: Description and presentation of the quality system in the Pharmacovigilance System Master File
- Sources of error in pharmacovigilance
- Which KPIs should/need to be defined?
- Compliance monitoring
- Ensuring compliance across your affiliates
- Liability issues
15:00 Coffee break
- Contract types and essential content
17:00 End of day 1
- Signal - an intuitive concept in a regulated framework
- Signal stages & collaboration in the EU
- The EudraVigilance Data Analysis System (EVDAS) and electronic Reaction Monitoring Report (eRMR)
- Transitional arrangements for EVDAS monitoring by MAH in the EU
- Communication of validated signals
11:00 Coffee break
- The GVP Module XVI in detail
- Routine vs additional risk minimisation activities
- Tool selection
- Evaluating the effectiveness of a measure or key performance indicator
- Training materials for HCPs and patients: Educational material - best practice
- Creation and distribution:
16:30 Seminar ends
Lawyer; His prime interests are the interdisciplinary challenges of medicinal product law. His focal advisory areas are as follows: - European and German medicinal product law - Marketing authorisation law & regulatory affairs - Pharmacovigilance - Wholesale trade with medicinal products, distribution of medicinal products - Manufacture of medicinal products
Nähere Informationen finden Sie hier.
Consultant Pharmacovigilance; Areas of expertise include medical writing of safety reports such PBRERs/PSURs, DSURs, PADERs, INDs, addendums to clinical overviews etc., adverse event management, setup and screening of global literature searches, and project management.
Epidemiologist, Senior Pharmacovigilance Assessor; Dr. F.A. Sayed Tabatabaei is an epidemiologist and senior Pharmacovigilance assessor at the MEB with more than 13 years experience in risk management of the medicinal products including estimation and categorisation of risks, choice of methods for additional pharmacovigilance activities, and choice of optimal risk minimisation measures and assessment of their effectiveness.
Head Strategic Data Analysis, Global Pharmacovigilance Member CIOMS Working Group VIII, Practical Aspects of Signal Detection in Pharmacovigilance
NL 1054 ES Amsterdam
Phone: +31 20 685 1351
Please send us your questions concerning the seminar topics in advance. We will be happy to forward them to the speakers, so that they know about your training requirements even better and are able to answer your questions at the seminar. Please send your questions to Jessica Hüske: firstname.lastname@example.org
At the end of the course, we will assess your understanding of the content with an online multiple-choice test. This comprises about 20 multiple-choice questions, 80% of which have to be answered correctly in order to pass. The test will be available online for two weeks and can be taken up to three times. Upon successful completion, you will be a certified pharmacovigilance expert. You will also be able to download a personalised certificate.
- Understand the impact of and apply the new adverse reaction reporting requirements.
- Be aware of the expectations of EudraVigilance.
- Identify, evaluate and take action on signals in accordance with GVP Module IX.
- Update your risk management system.
- Establish and monitor an efficient quality and compliance management system.
How to write the Module 3 for Regulatory Submission.
11.10.2019 in Köln
Do you need essential European regulatory affairs knowledge? This course gives you a compact overview about all important issues. Each day may be booked separately according to your needs!
25. - 27.11.2019 in Amsterdam
Tips & tricks for managing periodic reports and risk management plans post marketing authorisation. Furthermore insights into global PV document management will be given. Thus the training course gives you an allround overview.
21.10.2019 in Frankfurt
Save the date! Your regulatory update in pharmacovigilance with european drug safety experts and a special network event.
21. - 22.11.2019 in Mannheim