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.
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
- 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
09:00 – 13:00 COURSE SESSION DAY 1
09:00 – 13:00 COURSE SESSION DAY 2
May 30, 2024
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
• Qualified signal detection staff
9.30 Sources of signals
Different sources of signals will be discussed
• Post-marketing safety databases
• Epidemiology studies
• Clinical trials
• Toxicology and pharmacology
10.00 How do regulators themselves perform signal detection
The approach to signalling by different regulators will be discussed
• Local EU regulators
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
11:10 End of morning session
14:30 Start of afternoon session
14:35 Using Eudravigilance and EVDAS for signal detection Calin Lungu
The use of Eudravigilance and EVDAS. practical aspects of use of Eudravigilance and EVDAS will be presented
16:15 Q&A time
16:25 Closure of day one
May 31, 2024
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
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
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
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:
• Drug Safety and Risk Management
• Signal Management and Safety Science
• 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 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.
Expert in Signal Detection/Risk Management – CEO of PV Concultancy Ltd
Dr Glyn Belcher is a physician with more than 30 years experience in clinical development and drug safety in the pharmaceutical industry. His past is relevant for the role of Director of International Drug Safety and EU QPPV in Takeda; Head of Drug Safety and Risk Management and EU QPPV at Biogen Idec in UK and other. Today he is the owner and CEO of PV Consultancy Ltd. He is providing consultancy primarily in the field of Risk management and Signal detection.
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.
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