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.
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
April 28, 2021
9.00 Introduction to the course
9.10 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
9.50 Sources of signals
Different sources of signals will be discussed
• Post-marketing safety databases
• Epidemiology studies
• Clinical trials
• Toxicology and pharmacology
10.20 How do regulators themselves perform signal detection
The approach to signalling by different regulators will be discussed
• Local EU regulators
11:10 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
11:40 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
12:40 Q&A time
13:00 Closure of day one
April 29, 2021
9.15 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
10.00 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
10:50 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
11:20 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
11.45 What makes a good signal detection system
A summary of considerations to ensure signal detection to the appropriate standards can be achieved.
12:15 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
Glyn Belcher, M.D.
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.
TERMS OF PAYMENT
Advance payment is required with respect to the event date by bank transfer to BANCO BPM Spa – Florence (Italy), IBAN: IT90U0503402815000000001400, Bic/SWIFT: BAPPIT21G74 made payable to Pharma Education Center S.r.l., Via dei Pratoni 16, 50018 Scandicci (FI), VAT number 02173670486, specifying event title along with name and surname of the participant enrolling. Attendance to the event will be allowed upon payment received. Invoice of payment will be issued after the second half of the month after the course. For further information and/or further assistance please contact (+39) 055 7224179 or email: email@example.com
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