Signal Detection

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

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.