Signal Detection and Regulatory Expectations - 2 Day Programme (London, United Kingdom - May 5-6, 2020) - ResearchAndMarkets.com

DUBLIN--()--The "Signal Detection and Regulatory Expectations" conference has been added to ResearchAndMarkets.com's offering.

This two-day programme will give you a comprehensive review of signal detection and regulatory expectations including the new updated Signal Module IX and Eudravigilance quantitative signal requirement

Including the updated Signal Module IX and EudraVigilance quantitative signal requirement

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 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 under the updated Module IX signal management and quantitative assessments.

Benefits of attending:

  • Clarify the EU regulatory requirements for signal detection
  • Learn to use the EudraVigilance quantitative signal tool
  • Understand the safety review cycle and the safety review meeting and process
  • Understand EVDAS functionalities and outputs
  • Discuss safety communication - the CCSI/SCSI and labelling
  • Gain a better understanding of risk-benefit analysis - benefit-risk assessments and benefit-risk outcomes

Agenda:

Programme - Day one

An introduction to safety signals

  • History of safety signals
  • The nature of safety signals
  • The definition of safety signals
  • Safety sources for signal detection

Causality and signal detection

  • Causality assessments for signal review
  • Data quality in safety assessments
  • Causality versus incidence (DMEs and IMEs)
  • Generic and innovator products

The safety review meeting and process

  • Setting up a safety review
  • Risk determinations for safety review signal trackers
  • Information and templates
  • Logistical safety and product safety
  • Information from safety reviews

Safety assessments life cycle

  • Pre-clinical safety
  • Clinical safety
  • Class-related safety issues
  • Post-marketing safety
  • Product suspensions/withdrawals

Safety assessments life cycle (continued)

The regulatory requirements for signal detection - Module IX

  • The frequency of safety reviews (risk assessment)
  • The EU and US signal detection requirements
  • Signal detection and benefit-risk assessments
  • The regulators and signals

The signal review cycle

  • Safety profiling
  • Signal detection, validation, confirmation
  • Analysis and prioritisation, assessment
  • Recommendation for action

Programme - Day two

Quantitative and qualitative signal detections

  • Standard MedDRA Queries (SMQs) and signal detection
  • ICSRs and case quality
  • Follow-up methodology and regulatory requirements
  • Events of special interest

Signals and their discussion

  • Signals and DSURs
  • Signals and PSURs/PBRERs
  • Signals and risk management plans/REMs and minimisation
  • Signals and labelling

Safety communication

  • The CCSI/DCSI and labelling
  • Triaging for safety amendments
  • Emerging safety issues
  • Urgent safety restrictions
  • Product suspension and withdrawal

Quantitative signal analysis

  • Signal detection methodologies
  • Background - why quantitative signal detection?
  • Measures of disproportionality (PRR, ROR, MGPS, BCPNN)
  • Regulatory and industry activity (including EudraVigilance)

EVDAS and the EU

  • The PRAC and signals
  • The EVDAS system
  • Signals arising from EVDAS

Risk-benefit analysis

  • Calculating the extent of benefit by indication
  • Identifying significant product risks
  • Benefit-risk assessments
  • Benefit-risk outcomes

Speakers:

Graeme Ladds

Director

PharSafer Associates Ltd.

Graeme Ladds, Director of PharSafer, has over 22 years' experience working in the pharmaceutical industry. Having started his career at Ashbourne Pharmaceuticals in 1989 as Head of Drug Safety & Medical Information, Graeme went on to become Head of Global Pharmacovigilance at Shire Pharmaceuticals.

The last 11 years have been spent in his consultancy company, PharSafer Associates Ltd. During this time, Graeme has been involved in establishing pharmacovigilance in companies, performing audits across Europe and the USA, SOP writing, acting as QP for companies, and helping with regulatory inspections.

For more information about this conference visit https://www.researchandmarkets.com/r/umgimv

Contacts

ResearchAndMarkets.com
Laura Wood, Senior Press Manager
press@researchandmarkets.com
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

Contacts

ResearchAndMarkets.com
Laura Wood, Senior Press Manager
press@researchandmarkets.com
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