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. 

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 2021 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. Our Pharmacovigilance conferences are known for bringing the world-class leaders together to connect, learn and network. 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 2021 conference.


KEY DISCUSSIONS WE'LL BE EXPLORING

  • Pharmacovigilance and globalization
  • Pharmacovigilance in a pandemic world
  • 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 Workflows with AI & Automation
  • Other emerging technologies in PV

 

WHO SHOULD ATTEND PHARMACOVIGILANCE 2021

 

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.


Attendees includes Chief Data Officer, VPs, GMs, Directors, Heads and Managers of

  • 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

 

 

 

 

pharmaceutical companies

Speakers

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There are plenty of opportunities to position yourself as a thought leader & showcase your company.

For enquiries on speaker opportunities please e-mail to [email protected]



Tuesday - 23rd November 2021 (Time Zone - GMT)

  • 10:00
  • Welcome Address & Platform Orientation - Orientation will focus on how to access and navigate the virtual conference platform for Live Sessions & Interactive Networking

  • 10:20
  • Chairperson’s opening remarks

  • 10:30
  • 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

  • 11:00
  • 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.

    Rama DiopHead Patient Safety Region Africa
    Novartis

  • 11:30
  • Solution Provider Presentation

    For sponsorship opportunities please contact: [email protected] or call +44 (0) 207 096 0786

Drug Safety Strategies & Regulatory updates

  • 12:00
  • "X-functional Drug Safety Strategy" - How to set it up and why it is important


    Andreas OsangerDirector - Therapeutic Area Lead Nephrology
    Vifor Pharma

  • 12:30
  • Virtual Luncheon & Networking - Visit Exhibitor Booths & Network with your peers in our Lounge (Face to Face Video Chats)

     

                

  • 13:10
  • ICH in Brazil: New PV Regulation following Incorporation of ICH Guidelines


    Raphael Elmadjian PareschiAssociate Director Pharmacovigilance
    MSD

Adverse Event Reporting and Signal Detection

  • 13:40
  • Pharmacokinetics, Pharmacodynamics studies to minimize adverse event

    Assessment and categorization - adverse event reporting clinical trial, pre-/ post- marketing pharmacovigilance reporting timelines

     

    For sponsorship opportunities please contact: [email protected]
    or call +44 (0) 207 096 0786

  • 14:10
  • Innovative techniques and strategies in signal detection

    • The lacunae in existing technique
    • New strategies that have been implemented recently
    • How have implementation of new strategies benefited signal detection studies

    Dimitris ZampatisScientific Director, Safety Strategy Lead
    Healthcare Business of Merck

  • 14:40
  • Implementing a systematic approach in the area of drug safety and risk management

    • Assessment with comprehensive data quality
    • Compliant safety system (GxP compliant, inspection-ready system)
    • Safety signals, effective trials, strategic risk assessment decisions

    Allison StogdaleAssociate Director, Global Patient Safety & Risk Management
    Alnylam Pharmaceuticals

  • 15:10
  • Visit Virtual Exhibitor Booths/Speed Networking at our Exclusive Lounge (Face to Face Video chat with Exhibitors and other attendees)

     

         

Advanced therapy medicinal products (ATMPs) and PV

  • 15:30
  • Advanced therapeutic techniques and pharmacovigilance

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

  • 16:00
  • Applying a structured approach to benefit-risk assessment and illustrating how it can make a difference in decision making purposes and regulatory approvals of medicinal products"


    Stéphanie TchernyGlobal Head of Benefit-Risk Evaluation
    Sanofi

  • 16:30
  • Pharmacovigilance in Mexico: Updates and Challenges

    • Provide the most current Local Regulatory environment in terms of Pharmacovigilance in Mexico
    • Analyze the most important changes within Pharmacovigilance Guidelines

    Rodrigo RuizHead of Country Pharmacovigilance Mexico
    Bristol-Myers Squibb

Vendor Management and Outsourcing

  • 17:00
  • Pharmacovigilance Vendor Management

    • Procurement & Brand Teams
    • Vendor Oversight
    • Global & Local Regulations
    • Vendor Relationship Building

    Dawn MucciTeam Lead, Patient Safety Compliance and Enablement
    AstraZeneca

  • 17:30
  • Panel discussion: PV Outsourcing: Challenges and Opportunities

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

    Wivina De WaeleDirector EMEA, Global Drug Safety
    Alexion Pharmaceuticals, Inc

    Joan Francesc Aregall PicamalPharmacovigilance Country Head, Spain
    Bayer

  • 18:00
  • Chairperson’s closing remarks

  • 18:10
  • Virtual Networking - Catch-up with your peers in social lounge

     

         


Wednesday - 24th November 2021 (Time Zone - GMT)

  • 10:00
  • Welcome Address & Platform Orientation - Orientation will focus on how to access and navigate the virtual conference platform for Live Sessions & Interactive Networking

  • 10:20
  • Chairperson’s opening remarks

  • 10:30
  • ARTEMIS: Transforming Adverse Event Case Processing through Automation


    Julie GirodAssociate Vice President, Global Head of Case Management and Medical Evaluation
    Sanofi

PSMF, Eudravigilance & Data Management

  • 11:00
  • PSMF – Pharmacovigilance system master file

    •  PSMF summary design, role of QPPV and managing audits.
    • Responsibilities of stakeholders.
    • Accessibility of PSMF and Transparency and ensuring compliance
    • Challenges in the managing data collection, audit information and documenting changes in logbooks, transferring information to license partners or third parties

  • 11:20
  • Impact and Use of Digital Media in Pharmacovigilance


    Valentina ManciniDirector Pharmacovigilance, EU and UK QPPV
    Shionogi Europe

  • 11:40
  • Eudravigilance - how well has it been integrated and accepted by organizations

    • Improvement in data analysis and exchange of individual case safety reports (ICSRs) between EMA, and various parties.
    • The new and improved of Eudravigilance
    • Connecting EMA with other regulatory bodies using Eudravigilance

Post marketing surveillance & drug safety

  • 12:00
  • Post-marketing surveillance and Structured benefit risk

  • 12:30
  • Virtual Luncheon & Networking - Visit Exhibitor Booths & Network with your peers in our Lounge (Face to Face Video Chats)

     

                      

  • 13:10
  • An industrial perspective: Post-marketing Signal Detection and management

    • Present Drug safety signal detection systems and tools and what do they lack
    • Emerging techniques and tools in detection and management of signals
    • Sources for identifying safety signals

GVP & QPPV

  • 13:40
  • Pharmacovigilance Audit Inspection & Quality systems


    Tea BabicDirector, PV Audits and Inspections
    Teva Pharmaceuticals

  • 14:10
  • Reason, Scope and Significance of establishing good PV system

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

    Kishan NandhaPVQA Manager & Lead Auditor
    Astellas Pharma US

Next-Gen Technologies & PV

  • 14:40
  • Patient-Centric Pharmacovigilance: Building Better Outcomes through Integrated Technology to monitor quality and improve patient outcomes


    Raghda MohamedPatient Safety Cluster Lead - Middle East and Turkey / Global patient Safety Evaluation
    Takeda

  • 15:10
  • Visit Virtual Exhibitor Booths/Speed Networking at our Exclusive Lounge (Face to Face Video chat with Exhibitors and other attendees)

     

          

  • 15:30
  • Impact of Machine learning and artificial intelligence in PV

    • Ever expanding data and its safety
    • Importance and application of AI
    • Improving speed, accuracy and reliability using AI

     

    For sponsorship opportunities please contact: [email protected] or call +44 (0) 207 096 0786

  • 16:00
  • A New Era in Pharmacovigilance: Innovative Real-World Data approaches to transform the industry


    Ryan KilpatrickHead, Global Epidemiology
    Abbvie

  • 16:30
  • Panel Discussion: Innovation and the future of Pharmacovigilance

    • Importance of bringing patients on board
    • The need for patient database and effective communication
    • Automation, cognitive technologies, and advanced analytics
    • AI is Transforming Pharmacovigilance and Drug Safety
    • Emerging technologies, digitization and social platform
    • Benefits of digital technology and regulatory hurdles

    Yvonne NanciuCountry Head Pharmacovigilance Germany
    Bayer pharmaceuticals

    Kate GofmanGlobal Safety Physician, AI & Blockchain Innovator
    AstraZeneca

    Enrico SantusData Science Leader in Pharmacovigilance
    Bayer

  • 17:00
  • Improving patient involvement and wearables

    • Role of internet/ communication techniques, advertisement
    • Illegal effects
    • Post-market surveillance of devices
    • Therapeutic good administration
    • Safety management

    Victoria AbdalaROPU South America Pharmacovigilance Head
    Boehringer Ingelheim

  • 17:30
  • Chair Person’s closing remarks & End of the Conference

What do the Pass Include


  •  C-Suite keynote sessions & Panel Discussions
  •  Full 2-day live event Access
  •  Interactive live Video chat
  •  Interactive Social lounge with individual tables for discussions & Exchange of Information
  •  Q&A Session and polling
  •  Messaging meetings and networking with Industry Experts and Peers
  •  Access to Virtual expo (including videos, reports and articles from solution providers),
  •  Receiving Handouts
  •  On demand event recordings until 1 month
  •  Certificate for attending

BRING YOUR TEAM
Delegate Registration

Corvus Global Events recognises the value of learning in teams. There's so much great content!!!

Bring your team and get an extra discount. There are special group packages available. Please email to [email protected]for more details.

register now

PARTNERS

Partnerships typically involve an exchange of value and frequently include online content, PR, advertising, online & event branding.

For enquiries please e-mail to [email protected]

VIRTUAL PLATFORM

 

Our interactive platform has many rich features and they are a great experience for the users with Networking Video Chat, Polling, Raise Hand, Virtual Exhibitor booths with waiting room/tables, Q&A Sessions with industry experts, virtual chat, Peer to Peer connect at Social Lounge and Handout Bag

 

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