Two Day Course: Signal Detection and Regulatory Expectations (London, United Kingdom - November 25-26, 2018) - ResearchAndMarkets.com
DUBLIN--(BUSINESS WIRE)--Sep 18, 2018--The “Signal Detection and Regulatory Expectations” conference has been added to ResearchAndMarkets.com’s offering.
Featuring signal evaluation for both innovator and generic products under the newly revised Module IX Signal Management and quantitative assessments.
Increasingly the most common critical findings in Regulatory Inspections are being given for signal detection and management - so the need to identify potential signals and risks in patients has never been greater. The protection of patients through robust and clear methodologies for signal detection amidst the ever increasing regulations requires that Companies need 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 under the newly revised Module IX Signal Management and quantitative assessments.
Benefits in attending:Clarify the EU regulatory requirements for signal detection Understanding the new frequency requirements for safety review How to use the Eudravigilance quantitative signal tool Understand the safety review cycle and the safety review meeting and process Discuss safety communication - the CCSI/SCSI and labelling Gain a better understanding of risk benefit analysis - benefit-risk assessments and benefit-risk outcomes
Who Should Attend:
This course will be of interest to those working in drug safety/pharmacovigilance as well as Regulatory personnel responsible for amending the labelling for products and for the production of the CCSI/DCSI.
An introduction to safety signalsHistory of safety signals The nature of safety signals The definition of safety signals Safety sources for signal detection
Causality and signal detectionCausality assessments for signal review Data quality in safety assessments Causality versus incidence (DMEs and IMEs)
Generic and innovator products
The safety review meeting and processSetting up a safety review Risk determinations for a safety review signal trackers Information and templates for safety review Logistical safety and product safety Information from safety reviews
Safety assessments life cyclePre-clinical safety Clinical safety Class related safety issues Post-marketing safety Product suspensions and withdrawals
Safety assessments life cycle continued
The regulatory requirements for signal detection - Module IXThe frequency of safety reviews (risk assessment) The EU and signal detection requirements The USA requirements for signal detection Signal detection and benefit-risk assessments The regulators and signals
The signal review cycleSafety profiling Signal detection, validation, confirmation Analysis and prioritisation, assessment Recommendation for action
Quantitative and qualitative signal detectionStandard MedDRA queries (SMQs) and signal detection ICSRs and case quality Follow up methodology and regulatory requirements Events of special interest
Signals and their discussionSignals and DSURs Signals and PSURs / PBRERs Signals and risk management plans / REMs and minimisation Signals and labelling
Safety communicationThe CCSI / DCSI and labelling Triaging for safety amendments Emerging safety issues Urgent safety restrictions Product suspension and withdrawal
Quantitative signal analysisSignal detection methodologies Background - why quantitative signal detection? Measures of disproportionality (PRR, ROR, MGPS, BCPNN) Regulatory and industry activity (including Eudravigilance)
EVDAS and the EUThe PRAC and signals The EVDAS system Signals arising from EVDAS
Risk benefit analysisCalculating the extent of benefit by indication Identifying significant product risks Benefit-risk assessments Benefit-risk outcomes For more information about this conference visit https://www.researchandmarkets.com/research/gnxxs4/two_day_course?w=4
View source version on businesswire.com:https://www.businesswire.com/news/home/20180918005832/en/
Laura Wood, Senior Manager
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
KEYWORD: UNITED KINGDOM EUROPE
INDUSTRY KEYWORD: HEALTH PHARMACEUTICAL
SOURCE: Research and Markets
Copyright Business Wire 2018.
PUB: 09/18/2018 11:55 AM/DISC: 09/18/2018 11:55 AM