The training course “Audit and Inspection in Pharmacovigilance” will help the participant understand how well-designed and well-conducted pharmacovigilance audits allow pharmaceutical companies to identify any existing gaps or risks in their PV systems and procedures and to define activities and priorities for the continuous improvement of their PV quality systems. This has the aim to ensure compliance of the PV system to national and international legislation and recognized standards and to be ready to face GVP regulatory inspections. during the course, a deep review of the most important PV processes and interactions between internal and external stakeholders will outline more common areas of improvements according to auditors/inspectors expectations.
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
- Understand the specific requirement of a Pharmacovigilance Quality System and implement or improve this process in their own organisation
- Learn the key phases of the pharmacovigilance audit both as an auditor and as an auditee
- Focus on most important interactions of a Pharmacovigilance System and processes usually reviewed during GVP audit and inspections
- Learn how to approach and face up a GVP audit
- Learn how to prepare organization for a GVP inspection understanding the regulatory expectations
Struttura del corso
09:00 – 13:00 COURSE SESSION DAY 1
09:00 – 13:00 COURSE SESSION DAY 2
9.00 Introduction to the course
9.10 What are the main regulatory requirements and the organization of the PV System?
- Main requirements and key points
- Key PV processes
- Interactions with other company departments
- Q&A time
10.50 Coffe Break
11.10 GVP Audit
- Regulatory requirements
- Risk based approach
- Audit announcement, preparation and conduction
- CAPA plan monitoring
- KPIs on audit activities
12:40 Q&A Time
13:00 Closure of day one
9.15 Focus on GVP Inspection requirements
- Regulatory requirements
- Risk based approach
- Inspection announcement
- Q&A Time
10.30 Coffee Break
10:50 GVP inspection readiness
- Key points in the preparation of inspection
- Interaction with other company departments
- GVP inspection days
11.30 What are the main inspector’s expectations?
- Sharing of most common finding and experience
12:15 Key takeaways
12:30 Closure of the course
For professionals working in the following areas:
• Drug Safety and Risk Management
• Regulatory Affairs
• Clinical Research
• Quality and Compliance
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 email@example.com 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 firstname.lastname@example.org. 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.
The speaker is a pharmacovigilance expert dealing with Pharmacovigilance Systems since more than 20 years. With a Regulatory Affairs background she has been QPPV of a medium sized company having the opportunity to manage almost all pharmacovigilance processes within pharmacovigilance system and its quality system. Five years ago, she started working as Pharmacovigilance Consultant to assist clients improving compliance with the pharmacovigilance legislation and Good Vigilance Practices, from start-up phase of a pharmacovigilance system to creation and/or review and management of specific pharmacovigilance documents. In the last five years she has also conducted several GVP audits to client’s pharmacovigilance systems or to service providers/business partners on behalf of the clients and she has supported some pharmaceutical companies in preparing and facing up to GVP inspections.
You may also be interested in...
- 4-5 October 2023
- 12-13 March 2024
- 5 October 2023
- 27 February 2024
- 16 October 2023
- 29 February 2024
- 19 October 2023
- 6 March 2024
- 20 October 2023
- 18 April 2024
- 29 September 2023
- 6 March 2024
- 25 October 2023
- 11 April 2024
- 30 October 2023
- 28 February 2024
- 15-29 November 2023
- 8 March 2024
- 21 November 2023
- 22 April 2024
- 29 November 2023
- 14 May 2024