Glyn Belcher, M.D.
Expert in Signal Detection/Risk Management – CEO of PV Concultancy Ltd.
Calin A. Lungu, M.D.
BCPM, Eudravigilance and XEVMPD Trainer – EMA, CEO – DDCS
Times are UTC +1 (Rome time)
June 9, 2022
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
June 10, 2022
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
• Drug Safety and Risk Management
• Signal Management and Safety Science
• Quality and Compliance
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, M.D.
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.
€ 650 early bird fee, expires May 9, 2022
€ 750 full price
VAT not included. Discounts are not cumulative. Please inquire for discounts for multiple registrations.
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