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Conference Overview

With the augmented incidence of diseases, and the non-medical use of prescription drugs, the incidence of drug abuse has increased enormously in the recent years, which is apparent with the excess documentation of adversities and drug toxicities. In this context, the drug safety and pharmacovigilance has emerged as a dynamic clinical and scientific discipline to provide adequate information and ensure health safety by the joint interaction of doctors and patients in choosing appropriate treatment method and drug. However, evidences suggest though avoidable, the adverse drug reactions (ADRs) to medicines continue to be the bigger life risk. In England, ADR was responsible for up to 6% of hospital admissions, carrying a mortality of 2% and costing the NHS £466 million per annum (€654 million, US$ 602 million) in 2004. In some countries, ADR is ranked among the top 10 leading cause of mortality. The concept of drug safety and pharmacovigilance has evolved considerably and is highly necessary to keep the severity of ADR under check. In order to prevent or to reduce harm to patients and improve public health, it is vital to develop and practice mechanisms for evaluating and monitoring the safety of medicines in clinical use.  Pharmacovigilance brief the potential implications of such trends on the evolution of the science. 

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However, these days it is confronting issues to develop a better health care system in this global pitch. Some of the major challenges include globalization, web-based sales and information, broader safety concerns, public health versus pharmaceutical industry economic growth, monitoring of established products, developing and emerging countries, attitudes and perceptions to benefit and harm, outcomes and impact, etc. 

 

The Pharmacovigilance World 2020 conference will provide a platform for the participants to discuss, share and stay updated with present state of affairs in Pharmacovigilance and Drug safety, and contribute to the public health. It will also allow all its participants to interact with the experts, discuss the various developments, challenges faced and innovations in the field. The conference will bring-forth the participants and the representatives from various fields of pharmacovigilance and drug safety under a common umbrella, and will provide them an opportunity to network with various industry professionals including pharmaceuticals, biologics, devices, CROs and PV service providers.

 

It gives us a great pleasure in welcoming you to the Pharmacovigilance World 2020 conference.


KEY HIGHLIGHTS

  • Pharmacovigilance and globalization
  • Women and child health care medicines and pharmacovigilance
  • Patient-centric approaches in PV
  • Pharmacovigilance legislation and regulations
  • Harmonization and pharmacovigilance
  • Advanced therapeutic techniques and pharmacovigilance
  • Pharmacovigilance and data management and eudravigilance
  • Post-marketing surveillance in pharmacovigilance
  • PV regulations and challenges
  • Benefit-risk management strategies
  • Risk management and minimization
  • Adverse drug reactions reporting
  • Signal detection and post authorization safety
  • Good Pharmacovigilance Practices
  • Innovative approaches to drug safety
  • Strategies to improve PV
  • Real World Evidence in PV
  • Big data and AI in pharmacovigilance
  • Pharmacovigilance Monitoring and automation in Social media
  • Other emerging technologies in PV

WHO SHOULD ATTEND THE CONFERENCE

 

CEOs, CTOs, CIOs, Presidents, Vice Presidents, Directors, Heads & Managers, Scientific Advisors, Consultants and professionals who work for pharmaceutical, biotechnology & devices industries, CROs and service providers involved in Pharmacovigilance and Drug safety.

  • Pharmacovigilance
  • Safety & Risk management
  • Drug safety
  • PV Compliance
  • Safety Surveillance
  • Medical Affairs
  • Regulatory Affairs
  • Inspection and Audit
  • Pharmacoepidemiology
  • Post-market studies
  • Medical product safety assessment
  • Drug Research & Development
  • Clinical Pharmacology
  • Medical information
  • Contract outsourcing service providers
  • Health outcomes
  • Sales and Marketing

Speakers

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Wednesday - 3rd June 2020

  • 08:30

  • Registration & Refreshments

  • 08:50

  • Chairperson's opening remarks

  • 09:00

  • Morning Keynote: Pharmacovigilance in the Elderly - The importance of monitoring adverse drug reactions in elderly patients

    Giovanni Furlan

    Giovanni Furlan Safety Risk Lead - Director
     Pfizer

  • 09:30

  • Morning Keynote: Pharmacovigilance of women and child health care medicines and its challenges

    • Pharmacovigilance- significance, scope and challenges
    • Personalized medicines
    • Safe drug use: Adverse drug reactions, Adverse-drug interactions, monitoring

    Mate A. Balazs

    Mate A. Balazs Country Head - Patient Safety
     Novartis

  • 10:00

  • An Integrated care: Effective Implementation of vigilances systems

    • Separated vigilance systems can lead to the emergence of divergence in terms, definitions, variety of reporting forms and methods and the build of specific databases where cross analysis is no more possible.
    • To be more proactive and innovative in PV and to ensure that emerging problems are promptly recognized and solutions are effectively communicated
    • This integrated approach is very useful, especially for emerging countries to strengthen regulatory processes and to promote high standards of product vigilance for the protection of the health and safety of Citizens

  • 10:30

  • Morning Coffee/Tea & Networking

Legislation & Regulatory update

  • 10:50

  • PV regulations and challenges and how to accommodate all the various national requirements in a global organization

    Sabine Jeck-Thole

    Sabine Jeck-Thole EU QPPV and Head Regional Pharmacovigilance
     Boehringer Ingelheim

  • 11:20

  • International harmonization and drug regulatory requirement

    • Sales, information and knowledge of consumers
    • Awareness, generic names, reduction of medication errors in private clinics
    • Industrial association

    Julia Appelskog

    Julia Appelskog Head of QMS and Policy
     Merck

Inspection, Quality & Compliance

  • 11:50

  • Reason, Scope and Significance of establishing good PV system

    • Quality system within organizations
    • Critical PV process
    • Training
    • Risk management

  • 12:20

  • GxP inspections of PV system, scope, trends and challenges

    Raj Kaur Bhogal

    Raj Kaur Bhogal Director Regulatory Inspections, R&D Quality
     Takeda

  • 12:50

  • Networking & Luncheon

  • 13:30

  • Ensuring Quality Oversight in Pharmacovigilance

    Yvonne Nanciu

    Yvonne Nanciu Senior Manager Pharmacovigilance & Medical Information
     AbbVie

Advanced therapy medicinal products (ATMPs) and PV

  • 14:00

  • Advanced therapeutic techniques and pharmacovigilance

    • Advanced therapeutic techniques and pharmacovigilance
    • Challenges related with monitoring and safety
    • Benefit-risk assessment of ATMP

    Pavel Garkaviy

    Pavel Garkaviy Director Physician
     AstraZeneca

  • 14:30

  • Major developments in regulatory framework

     

    • The future of gene therapy, stem-cell therapy, and tissue engineering
    • EU guidelines and updates - Good Manufacturing Practices for ATMPs

  • 15:00

  • Afternoon Tea/Coffee

  • 15:20

  • Interactive Roundtable Discussion

    All attendees will have a great opportunity to discuss a selection of the most interesting topicsaddressed during the conference in small groups with their peers.

    Every table will nominate a head of the table, who will summarize the topic discussed, presentthe main puzzles and questions posed

Strategies and Outsourcing

  • 15:50

  • Strategies to improve Pharmacovigilance

  • 16:20

  • Panel discussion: with session speakers and interaction with the floor

    PV Outsourcing: Challenges and Opportunities

    • Economy
    • PV Quality assurance
    • post-authorization safety studies
    • Building partnerships
    • Identifying the key areas for outsourcing
    • The main challenges faced and impact of new legislation
    • Core competencies, activities-database, follow-up studies, case-studies, etc.

    Salvatore Giorgio Cicirello

    Salvatore Giorgio Cicirello Senior Director Safety Science & PASS, Global Drug Safety & Risk Management
     Celgene

    Ricarda Tiemeyer

    Ricarda Tiemeyer Associate Director Head of Pharmacovigilance
     Biogen

  • 16:50

  • Chairperson’s closing remarks

  • 17:00

  • Networking Drinks Session

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