Signal Detection
- 26-27 May 2025
- Online
-
English
- 26-27 May 2025
- Online
-
-
English
-
Training overview
Recently, some of the most common critical findings in regulatory pharmacovigilance inspections are being given for signal detection and management, so the need to identify potential signals and risks in patients has increasing importance. The protection of patients through robust and clear methodologies for signal detection amidst the ever-increasing regulations requires companies to have trained and competent staff to perform such activities. This course will provide a detailed overview of all aspects of safety reviews and signal detection within a company and will cover signal evaluation for both innovator and generic products as required by regulations.
Would you like to participate, but you’re not available on this date?
The course will be provided again:
- 26th and 27th 2025
(*) Contact us via email or phone to enroll.
Interested in Pharmacovigilance training?
Enroll in 3 courses and you’ll get a 15% discount*, while choosing 5 courses will grant you a 20% discount*!
Choose among these titles:
- Risk Management Plan & Risk Minimization Measures in Farmacovigilanza
- Il Pharmacovigilance Quality System: Costruire un Sistema in Compliance
- Ricerche e Analisi di Letteratura in Farmacovigilanza
- SDEA: i Contratti in Farmacovigilanza
- Pharmacovigilance System Master File (PSMF)
- Signal Detection – English training
- Periodic Safety Update Report (PSUR)
- Audit and Inspection in Pharmacovigilance – English training
- Evoluzione della Farmacovigilanza e impatto della Digitalizzazione
- Il sistema di Farmacovigilanza e le sue applicazioni locali secondo la normativa ed Eudravigilance
- Ruoli e Responsabilità del Local Contact Point for Pharmacovigilance
(*) discounts apply to the full prices of the courses and cannot be combined with other promotions.
The promotion is limited to enrolling the same person in 3 or 5 courses selected from those offered.
Key points of the training
- Apply the concepts and principles of signal management in PV and implement or improve this process in their own organisation
- Understand different approaches to signal management that are followed by various organisations
- Understand different approaches to signal detection for different medicines
- Understand the concept of signal detection algorithm (SDA), signal of disproportionate reporting (SDR) and its use in EVDAS
- Learn how to use and implement EVDAS into signal management process
- Understand the role of signal detection in the assessment of emerging safety profiles of medicine
- Understand the regulatory expectations in different geographic regions
Course Structure
09:00 – 16:30 COURSE SESSION DAY 1
09:00 – 12:30 COURSE SESSION DAY 2
Programma
Day 1
9.00 What is signal detection and what are the regulatory requirements for signal detection?
The nature of signal detection and the various regulatory requirements will be presented.
– What organisation in a marketing authorisation holder should perform signal detection and how should they be staffed
• Central safety organisation
• Affiliates
• Qualified signal detection staff
Q&A time
9.30 Sources of signals
Different sources of signals will be discussed
• Post-marketing safety databases
• Epidemiology studies
• Clinical trials
• Toxicology and pharmacology
• Literature
• Others
Q&A time
10.00 How do regulators themselves perform signal detection
The approach to signalling by different regulators will be discussed
• EMA
• Local EU regulators
• FDA
• Others
Q&A time
10:20 BREAK
10:40 Use of safety databases for signal detection
The theoretical basis of signal detection from post-marketing safety databases and their appropriate use will be discussed
• Qualitative signal detection
• Quantitative signal detection
– Disproportionality analyses
• Longitudinal analyses
Q&A time
11:10 End of morning session
14:30 Start of afternoon session
14:35 Using Eudravigilance and EVDAS for signal detection
The use of Eudravigilance and EVDAS. practical aspects of use of Eudravigilance and EVDAS will be presented
16:15 Q&A time
16:30 Closure of day one
Day 2
9.00 Assessment of signals by marketing authorisation holders
How signals assessed will be discussed
• Validating a signal
• Prioritization of a signal
• Investigation of a signal
• Closing a signal
Q&A time
09.40 Link between signal detection and the PSUR and risk management plan
The important links between signal detection, PSURs, drug label and risk management plan will be reviewed
10:00 Audit and inspection of signal detection activities
Appropriate approaches to ensure quality of signal detection activities will be presented
• Quality system for signal detection
– Key Performance Indicators
• What to audit
• Pharmacovigilance inspectors assessment of signal detection
Q&A time
10.25 BREAK
10.45 Exercise
Delegates will be provided with data concerning signal activities to discuss together to determine the appropriate signal status that the data supports. This will be followed by discussion of the conclusions proposed.
11:45 Signal detection during clinical development of new chemical entity
What role does formal signal detection have during the clinical development of a medicine and how best to document this will be discussed
Q&A time
12.00 What makes a good signal detection system
A summary of considerations to ensure signal detection to the appropriate standards can be achieved.
12:20 Final questions session
12:30 Closure of the course
For professionals working in the following areas:
• Pharmacovigilance
• Drug Safety and Risk Management
• Signal Management and Safety Science
• Pharmacoepidemiology
• 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.
Cancellation terms
In order to cancel enrolment to an event, please email info@pharmaeducationcenter.it within 2 weeks before the starting date of the event. Once this term will be expired, the entire fee will be charged.
Participant replacement
It is possible to replace a participant attendance without additional cost, simply by contacting info@pharmaeducationcenter.it. 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.
Training cancellation
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.
Speakers
Calin A. Lungu
MD, BCPM, Eudravigilance and XEVMPD Trainer – EMA, CEO – DDCS
Dr. Calin Lungu is a physician with a notable experience in PV and quality assurance . He is a very esteemed, well-known trainer for EudraVigilance, XEVMPD and EVDAS having teached for European National Competent Authorities and the European Medicines Agency. Dr. Lungu is the CEO of Drug Development Consulting Services.
Register now
850€
Training materials available for attendees
Certificate of attendance
Senior trainers with hands-on experience
You may also be interested in...
- September 30th 2024
- March 3rd 2025
- Online
- October 8th and 9th 2024
- March 11th and 12th 2025
- Online
- PROMO
- 14 October 2024
- 19 March 2025
- Online
- 17-18 October2024
- 27-28 March 2025
- Online
- 6 December 2023
- 24 May 2024
- Online
- 6 November 2024
- 2 April 2025
- Online
- 15 November 2024
- 6 May 2025
- Online
- NEW
- 20 November 2024
- 14 May 2025
- Online
- 25 November 2024
- 4 June 2025
- Online
Since October 2015, Annex 15 of the European GMP has been in effect. With this revision, modern process aspects are [...]
- PROMO
- 29 November 2024
- 9 June 2025
- Online
- PROMO
- 10 December 2024
- 5 June 2025
- Online
- PROMO
- NEW
- 12 December 2024
- 11 June 2025
- Online