In accordance with current regulations, it is the responsibility of Marketing Authorization Holders and Competent Authorities to continuously monitor risks related to the use of medicines authorized in the European Union and to implement all appropriate actions to minimize risks and maximize benefits by ensuring the accuracy, update, and timely communication of all information produced related to medicines for human use. Through continuous interaction with the instructor and hands-on sessions, the course aims to provide a general and in-depth overview of the proper implementation of the risk management system in Pharmacovigilance and the use of related regulatory tools to support it.
ARE YOU INTERESTED IN PHARMACOVIGILANCE TRAININGS?
Sign up for 3 courses and you’ll get a 15% discount*, while if you choose 5 courses you’ll get a 20% discount*. You may choose from these trainings:
- Periodic Safety Update Report (PSUR)
- The Pharmacovigilance system and its local applications according to legislation and Eudravigilance
- Safety Data Exchange Agreements (SDEA) in Pharmacovigilance: training course + workshop
- Pharmacovigilance peer-reviewed literature: strategies for an effective research and analysis
- Building a compliant Pharmacovigilance Quality System
- Risk Management plan & Risk Minimization Measures in Pharmacovigilance
- Pharmacovigilance System Master File (PSMF)
- HIGHLIGHTED COURSE – Audit and Inspection in Pharmacovigilance
- The digital evolution of pharmacovigilance
- HIGHLIGHTED COURSE – Signal Detection
(*) discounts apply to full prices and cannot be combined with other promotions. The promotion is valid for the enrollment of the same attendee in 3 or 5 courses among those proposed.
Key points of the training
- Know the up-to-date reference legislation on risk management in Pharmacovigilance
- Identify appropriate Risk Management Plan formats and content for each type of product
- Write a Risk Management Plan in accordance with regulatory requirements
- Manage the life cycle of corporate Risk Management Plans
- Identify appropriate Risk Minimization Measures
Struttura del corso
09:30 – 12:30 MORNING SESSION
14:00 – 17:00 AFTERNOON SESSION
Risk management: definitions and relevant legislation
- GVP Module V new edition
- Other GVPs referenced
RMP formats and content
- RMP template: old and new formats
- Contents of the RMP
- Interface with other regulatory documents
- Procedures for evaluation by Regulatory Authorities
- Tracking System
Risk Minimization Measures (RMM)
- RMM Routines
- Additional RMM
- Verification of effectiveness
- Practical examples: educational materials
Interactive workshop: setting up an RMP for an established product (generic, established use or hybrid) and for an innovative product
The workshop will be conducted as follows:
Participants will be divided into groups of 2/3 (depending on the number of delegates). It is preferable that people with different specializations participate in each team for the purpose of better interchange.Each group will set up an RMP based on the product and information provided; each group’s deliverables will then be reviewed and commented on with all participants, highlighting any mistakes made and suggesting optimal alternative solutions.
Pharmacovigilance (PV Manager, Drug Safety Manager, QPPV, Safety Officers, PVQA), Regulatory Affairs, Clinical Research, Data Management.
The course will be carried out through live lectures. Practical examples will be showcased, providing delegates with real life examples to be applied in their daily job life.
For online trainings the access link will be sent 2-3 days before the start of the training.
5% discount for registrations within 1 month before the start of the training, 10% discount for registrations within 2 months before the start of the training. VAT not included. Please inquire for discounts for multiple registrations. Discounts are not cumulative.
In order to cancel enrolment to an event, please email firstname.lastname@example.org within 2 weeks before the starting date of the event. Once this term will be expired, the entire fee will be charged.
It is possible to replace a participant attendance without additional cost, simply by contacting email@example.com. It is asked to notify the participant replacement request within 5 days before the starting date of the course/event, specifying the full name and surname of the enrolled participant as well as the full name and surname of the substitute.
If the minimum number of participants is not reached, Pharma Education Center reserves the right to cancel or schedule the event for another date. Formal communication will be given within 5 days before the event date. In this case Pharma Education Center will refund the registration fee in full and without additional charges. Alternatively, the participant can request a spendable coupon for participating in another PEC event scheduled in the current year.
Graduated in Chemistry and Pharmaceutical Technologies at the University of Milan in 1998, she began her working career in the field of Regulatory Affairs and Pharmaceutical Technological Development; she has been involved in Pharmacovigilance for 18 years and since 2004 she has been Head of Pharmacovigilance at AIFA and the European QPPV of DOC Generici S.r.l., where she set up and managed the company pharmacovigilance system by directly intervening in all processes concerning pharmacovigilance including the drafting of numerous Risk Management Plan. She currently carries out consultancy activities in Pharmacovigilance. She has attended and still participates in refresher courses in Italy and abroad and she is a lecturer at the Master’s in Regulatory Disciplines at the University of Pavia and at the second-level Master’s in Pharmacovigilance at the University of Milan. She is member of the Pharmacovigilance group of AFI and of the Society of Applied Pharmacological Sciences.
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