What is a Pharmacovigilance Quality System and why is it important?
According to current regulations, it is the responsibility of AIC Holders or Marketing Authorization Holders (MAHs) to put in place and maintain a Pharmacovigilance System and its quality system: a Pharmacovigilance Quality System that is adequate to detect any changes in the benefit/risk profile of authorized medicinal products.
The construction of an effective and efficient Quality System requires, first and foremost, the presence of adequate, competent resources properly trained, adequate tools and infrastructure, and also the implementation of organizational and procedural aspects, as well as periodic monitoring of their effectiveness, with identification and evaluation of Key Performance Indicators. Finally, the necessary actions must be taken to achieve the improvements and reach the expected standards. In fact, it turns out to be essential the systematic activity of “Auditing,” to be implemented in line with international standards and recalled in the same GVP, Good Pharmacovigilance Practice.
Pharma Education Center’s “The Pharmacovigilance Quality System” training course aims to examine all these key aspects, answering participants’ doubts.
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 relevant regulations underlying the Quality System in Pharmacovigilance
- Identify the organizational and procedural elements for an effective PQS
- Learn how to set up and perform an Audit
- Putting in place and monitoring improvement actions (CAPAs)
Struttura del corso
09:30 – 12:30 MORNING SESSION
14:00 – 17:00 AFTERNOON SESSION
The FV Quality System: Organization and Governance
- Governance (global, regional, local)
- Key figures in Quality: roles and responsibilities
- Management interactions with other functions
- Interactions with the business The FV Quality System: key aspects
- The PSMF and the Quality System
- Effective SOP system for Pharmacovigilance
- Documentation Management
- Tools (IT, facilities)
The PV Quality System: audits
- Audits and CAPA management
Inspections The FV Quality System: performance assessment
- Performance Indicators
- Relationships with Management Q&A Session
The course was designed for personnel involved in the following areas: Pharmacovigilance (PV Manager, Drug Safety Manager, QPPV, Safety Officer, PVQA), Regulatory Affairs, Clinical Research, QA, Auditor.
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.
Senior Drug Safety Manager at Biogen
Graduated in Biological Sciences in 2001 at the University of Milan, she worked for about three years at the National Cancer Institute of Milan. She began her career within the pharmaceutical industry in the Medical Department of Novartis Italia S.p.a with the role of Senior Clinical Safety Associate. Subsequently she continued her career in Recordati S.p.a. where she holds the role of Deputy of the QPPV in a Mother House. From 2009 to 2015 she was Pharmacovigilance Manager of the Italian subsidiary of Grunenthal Italia S.p.a. Since 2015 she has held the role of Local Pharmacovigilance Contact in Biogen Italia S.r.l.. Since 2015 she has been involved in training and teaching activities at PEC courses and since 2016 she has been a lecturer at the School of Farmindustria and a lecturer in ECM training courses at public hospital facilities. Furthermore, since 2019 she has been an active part of the Simef pharmacovigilance working group.
You may also be interested in...
- 19-20 September 2023
- 28-29 February 2024
- 4-5 October 2023
- 12-13 March 2024
- 16 October 2023
- 29 February 2024
- 18-19 October 2023
- 27-28 March 2024
- 26-27 October 2023
- 27 October 2023
- 12 April 2024
- 31 October 2023
- 8 April 2024
- 15-29 November 2023
- 8 March 2024
- 29 November 2023
- 22 March 2024
- 11-12 December 2023
- 23 February - 1 March 2024