Saturday, August 6 2022


Dublin, November 08, 2021 (GLOBE NEWSWIRE) – The “Pharmacovigilance training course” the conference has been added to ResearchAndMarkets.com offer.

This comprehensive three-day course has been designed to provide an introductory guide for anyone concerned with pharmacovigilance. The interactive program will cover topics ranging from basic pharmacovigilance principles and terminologies to the current regulatory framework and its global impact, including the oversight of medicines in the EU, US and Japan. Proactive pre- and post-market pharmacovigilance will be addressed, as will risk management, challenges of causality assessments and effective signal detection.

Our expert panel will offer practical advice throughout the course and use real-life examples and case studies to help develop your knowledge. There will also be plenty of opportunities to share experiences with speakers and professional colleagues, which will further enhance your understanding of pharmacovigilance issues.

The main topics to be covered include:

  • Pharmacovigilance principles and data resources
  • Risk management, causality assessment and post-authorization safety and efficacy studies (PASS / PAES)
  • Pharmacoepidemiological studies and evolution of periodic safety update reports (PSUR), periodic benefit-risk assessment reports (PBRER) and updated safety development reports (DSUR)
  • Proactive pre- and post-marketing pharmacovigilance, risk-benefit assessment
  • Pharmacovigilance regulations, ADR reporting requirements for clinical trials n Drug monitoring in countries outside Europe
  • Drug monitoring in countries outside Europe
  • Post-marketing surveillance: observational cohort studies
  • An overview of signal detection and risk management (RMP) plans

Who should be present:

Anyone involved and interested in the daily practice of pharmacovigilance, including pharmaceutical doctors and those working in:

  • Drug safety
  • Monitoring of adverse reactions
  • R&D
  • Regulatory Affairs
  • Registration

Main topics covered:

Pharmacovigilance principles and data resources

  • Basic Principles of Drug Safety Oversight
  • An overview of the methodology
  • Data resources available for monitoring and evaluating drug safety
  • Respond to medication safety signals

Risk management and minimization: basic principles

  • Basic principles
  • Proactive strategies
  • Principles of risk minimization
  • PASS and PAES

Causality assessment: clinical diagnosis of adverse events

  • Principles of causality assessment with practical examples
  • Medical evaluation of individual reports of adverse events
  • Follow-up strategies

The current regulatory framework and its global impact

  • Overview of the European regulatory framework, including the 2012 EU pharmacovigilance legislation
  • Implications for the global environment – links to ICH and CIOMS recommendations
  • Inspections and penalties for non-compliance
  • Practical applications of definitions

European post-marketing pharmacovigilance regulations

  • The role of the Pharmacovigilance Risk Assessment Committee (PRAC) and the SCOPE initiative
  • Quality management systems and pharmacovigilance system master file (PSMF)
  • QPPV
  • Expedited reporting: solicited vs. spontaneous
  • Periodic reports and signal management and use of EudraVigilance
  • PGR and risk minimization
  • PASS / PAES
  • Additional monitoring
  • Pharmacovigilance inspections / audit
  • Public hearings including first EMA hearing – September 2017
  • Stakeholder involvement initiatives such as PROTECT, WEB-RADR
  • New electronic reporting standards, E2B (R3), IDMP

Proactive pharmacovigilance before and after marketing

  • Anticipate drug safety issues in the development of small molecules and biologics
  • What specific and non-specific security monitoring should be carried out?
  • Management of safety signals in development
  • Differences between pre-market studies and post-market experience

Risk and benefit assessment

  • General principles
  • Quantify the risk
  • Act to optimize the risk-benefit ratio
  • Monitoring the effectiveness of risk management measures

ADR reporting requirements for clinical trials

  • ICH E2A and general requirements
  • Expedited Reports
  • EU Clinical Trials Directive, Clinical Trials Regulation and Detailed Guidelines
  • US IND requirements
  • DSUR

Pharmacoepidemiological studies – basic concepts, strengths, weaknesses and examples

  • Real-world data reigns supreme
  • Randomization in the real world
  • Drugs and devices – it’s all “exposure”
  • Follow all patients?

Periodic reports – PSUR and PBRER

  • Evolution of PSUR, PBRER and DSUR
  • What do we submit and when to submit it
  • Practical aspects of compiling PSURs and PBRERs
  • Link DSURs, RMPs, PSURs, PBRERs and Critical Safety Information

Drug monitoring in countries outside Europe

  • american culture
  • NDA and IND safety reports
  • Controls
  • Japanese culture
  • Post-market safety oversight programs in Japan
  • Pharmacovigilance in other countries

Practical aspects of signal detection

  • Signal definitions
  • Regulatory guidance on signal detection by industry and regulators
  • Resources for signal detection
  • Quantitative vs qualitative signal detection

Examples of pharmacoepidemiological studies used in risk management

  • How we weigh the evidence
  • Observational cohort studies
  • Case-control studies
  • Drug registers (anti-TNF)
  • Pregnancy registers

Practical aspects of risk management

  • A concrete example of the development of a successful European RMP
  • Industry Perspective PMP Requirements
  • How to write a successful RMP
  • Report the results of the results of the activities in the PMP
  • Update an RMP

Practical pharmacovigilance workshop

  • A practical case study with valuable practical experience
  • Manage an important security alert from regulators
  • Risk assessment
  • Determine measures to respond to previously unidentified risks
  • Ongoing assessment and risk-benefit communication

Loudspeakers

Glyn Belcher

Dr Glyn Belcher has over 25 years of clinical development and drug safety experience in the pharmaceutical industry. He graduated in medicine from Oxford and Cambridge and obtained his doctorate in neuropharmacology from the latter university. After several years in hospital medicine, he joined Schering and worked in clinical research in the UK branch before moving to the headquarters in Berlin, first as head of cardiovascular clinical research, then as head. a new security department covering clinical development activities. He then became Director of Clinical Drug Safety and EU QPPV for Takeda Europe and Head of Global Safety at Takeda Headquarters in Osaka. His most recent role in the industry was as Vice President of Drug Safety and Risk Management for All Non-US Territories for Biogen Idec and EU QPPV for the Company. He now has his own consultancy firm, PV Consultancy Ltd, and works with a number of companies in the areas of clinical development and drug safety, while increasingly engaging in education and training. training in these areas.

Shelley gandhi

Shelley Gandhi joined NDA Group AB in 2012 and previously worked for the MHRA (UK Regulatory Authority) for 19 years. She has in-depth knowledge of all European regulatory processes relating to the oversight of the safety of authorized medicinal products and ancillary devices and has studied the possible risks and taken appropriate measures to minimize the risks to public health through the committees. European and national.
She was unit head of the Vigilance and Intelligence Research Group where she led a team of 30 people whose main role is to carry out risk assessments. During her last year at the MHRA, she mainly focused on putting in place new pharmacovigilance legislation in Europe and ensuring that the MHRA would be ready.
She is currently using this regulatory experience to work with industry to ensure that they are implementing new pharmacovigilance legislation.

Seema Jaitly

Dr Seema Jaitly graduated from Charing Cross and Westminster Medical School in 1992 and worked in hospital medicine for four years. She has worked in the pharmaceutical industry for over 18 years for CROs and companies spanning clinical research, medical affairs, pharmacovigilance and the role of the EU QPPV. In 2010, she founded Essjay Solutions to offer pharmacovigilance, consulting and contracting services.
She is currently studying for a Masters in Epidemiology at the London School of Hygiene and Tropical Medicine.

John Parkinson

John Parkinson is a data and pharmacoepidemiology consultant. He previously worked as Director of Clinical Practice Research Datalink (CPRD) at MHRA, which grew from the General Medicine Research Database (GPRD) and Research Capacity Program at NIHR. It has been instrumental in enabling the linkage of NHS data records and their wide use in many aspects of pharmacoepidemiology, as well as providing information to the pharmaceutical industry on studies and types of studies that companies may find useful in their quest to make effective data and safe medicines available

Saad Shakir

Saad Shakir is Director of the Drug Safety Research Unit. After graduating and working in medicine, he worked in pharmacovigilance and pharmacoepidemiology for over a decade, first at the Medicines Control Agency (MCA) in the UK and then in the pharmaceutical industry. He has worked and advised on numerous drug safety issues, including product recalls and major safety risks. He is the author of numerous publications in scientific journals on pharmacovigilance and pharmacoepidemiology and is a member of the editorial boards of the journals of Pharmacoepidemiology and Drug Safety.

For more information on this conference, visit https://www.researchandmarkets.com/r/tbivag

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