Periodic Safety Update Reports, also called PSURs, are pharmacovigilance documents aimed at providing an assessment of the risk-benefit balance of a medicinal product. They are to be submitted by a marketing authorization holder at predefined deadlines during the post-authorization phase, including a comprehensive, concise and critical analysis of the risk-benefit balance of a medicinal product, taking into account all new or emerging information, in relation to the context of the overall information available on the drug.
Directive 2010/84/EU introduced the principle of single European assessment of PSURs (PSUSA procedure), for medicinal products containing the same active substances or combinations thereof and established the creation of a single list of active substances and associated Data Lock Points (EURD list). Compliance with the recommendations and conclusions of the PSUSA procedures is a legal obligation for AIC holders, also including medicinal products exempted from participation in the procedure but containing the same active ingredients.
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
- Reference legislation for the PSUR
- How to develop the plan of PSURs (requirements and submission frequencies)
- What is the format of the PSUR and what information should be submitted and analysed?
- What interactions with other business departments may be necessary in drafting the document and its submission
- What are PSUSA and PSUSA FU procedures and what actions may result from them
09:00 – 13:00 COURSE SESSION
- European regulatory framework and guidelines
- PSUR submission timings and drugs exempted from PSUR submission: creation of the PSUR plan (Eurd List monitoring, consultation of other lists, …)
- PSUR format and document contents (including information to be requested from other departments). Key concepts will be described and which relevant information should be included and discussed in the document will be clarified
- Cross references with other documents and activities (RMP, signal analysis,…)
- Submission to PSUR repository (general description of steps)
- PSUSA procedure: what it is, which steps, examples of assessment reports and requests from the assessor, output of the procedure and regulatory consequences
- PSUSA Procedure FU
Personnel of pharmaceutical companies involved in the following departments:
> Regulatory Affairs
The course provides the theoretical foundations necessary to undertake the drafting of a PSUR and provides indications regarding the management and planning of the PSURs to be submitted.
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.
Senior Drug Safety Officer
Senior Drug Safety Officer
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