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 how it contributes 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.


Conference Streams Include

 

 

Global PV & Methodologies

Data management & Analytics in PV

PV Automation, AI & Machine Learning

Safety Signals & Management

Pharmacovigilance Regulations

Risk
Management

Patient Centric Drug Safety

Case
Management

Quality &
Compliance

Pharmacovigilance Outsourcing

Medical Devices Safety

Adverse Drug Reactions

 

 

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
  • Risk Evaluation and Mitigation
  • 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

VIEW ALL

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

      Watch Session
    Uwe Gudat (Moderator)

    Uwe Gudat (Moderator) Head of Medical Affairs & CSPV
    Fresenius Kabi

  • 10:30
  • 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

      Watch Session   Presentation
    Stephanie Tcherny

    Stephanie Tcherny Global Head of Benefit-Risk Evaluation
    Sanofi

  • 11:00
  • "X-functional Drug Safety Strategy" - How to set it up and why it is important

      Watch Session   Presentation
    Andreas Osanger

    Andreas Osanger Director - Therapeutic Area Lead Nephrology
    Vifor Pharma

  • 12:00
  • Virtual Luncheon & Networking - Visit Exhibitor Booths & Network with your peers in our Lounge (Face to Face Video Chats)

     

                

  • 12:55
  • Novel AI for Extraction of Adverse Events and Auto Generation of Adverse Event Reports

      Watch Session
    Jingqing Zhang

    Jingqing Zhang Head of AI
    Pangaea Data

  • 13:20
  • ICH in Brazil: New PV Regulation following Incorporation of ICH Guidelines

      Watch Session
    Raphael Elmadjian Pareschi

    Raphael Elmadjian Pareschi Associate Director Pharmacovigilance
    MSD

Safety Signals and Risk Management

  • 13:40
  • Pivoting Safety to a Strategic Center - with an End-to-end AI Enabled Data Fabric

    • Learn how technology and industry trends are creating opportunity to transform safety to a strategic driver.
    • Gain perspective on how safety systems must evolve to seize this opportunity
    • Hear about ArisGlobal's progress toward enabling the future of pharmacovigilance.
      Watch Session
    Beena Wood

    Beena Wood VP, Safety Product Management
    ArisGlobal

  • 14:10
  • Signal Management in Pharmacovigilance – What Is New?

    •  Routine signal detection methods in EudraVigilance
    • Ongoing monitoring activities for signal detection
    • Enhanced quantitative signal detection methods (data mining)
    • Qualitative vs. quantitative assessment of ICSRs
      Watch Session   Presentation
    Dimitris Zampatis

    Dimitris Zampatis Head of Pharmacovigilance EMA- EU/UK QPPV
    Lupin Europe

  • 14:30
  • 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
      Watch Session   Presentation
    Allison Stogdale

    Allison Stogdale Associate Director, Global Patient Safety & Risk Management
    Alnylam Pharmaceuticals

  • 14:50
  • What does a signal, signal?

      Watch Session
    Uwe Gudat (Moderator)

    Uwe Gudat (Moderator) Head of Medical Affairs & CSPV
    Fresenius Kabi

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

     

         

  • 15:20
  • Fireside Chat: Strengthening Risk Evaluation and Mitigation Strategies (REMS)

    • Creating a REMS Industry-Wide Standardized Risk Evaluation and Mitigation Strategy (REMS) Program
    • Global regulatory developments
    • EU GVP XVI revision – what we could expect?
    • REMS for generics
    • Effective tools and strategies to improve REMS effectiveness
    • REMS at the patient-level: improving safety and proper use of medicines
    • Evolving REMS: New opportunities for branded drugs 
    • What have we learned? Next steps toward the future 
      Watch Session
    Uwe Gudat (Moderator)

    Uwe Gudat (Moderator) Head of Medical Affairs & CSPV
    Fresenius Kabi

    Lisa Stagi

    Lisa Stagi Drug Safety & Quality Head
    Roche

    Kal Elhoregy

    Kal Elhoregy Director, Risk Evaluation and Mitigation Strategies
    Amneal Pharmaceuticals

    Lisa Benaise

    Lisa Benaise Vice President, Head of Pharmacovigilance
    Calliditas Therapeutics

    Klaudija Marijanovic Barac

    Klaudija Marijanovic Barac Sr. Director, TPC - Global PSUR & RMP Unit
    Teva Pharmaceuticals

  • 16:00
  • How PV is implemented in MENA

    What do you need to know about the rapidly evolving GVP implementation in the MENA region? Are you keeping the pace to be compliant to local authorities?

      Watch Session   Presentation
    Shahinaz Badr

    Shahinaz Badr Regional Pharmacovigilance Manager
    NewBridge Pharmaceuticals

  • 16:20
  • Post-marketing Signal Detection and management from industrial perspective

    • Sources for identifying safety signals 
    • Present Drug safety signal detection systems and tools and what do they lack 
    • How we can improve the techniques and the tools to have a more efficient signal detection and management 
      Watch Session
    Luca Cariolato

    Luca Cariolato Head of Signal Management
    Vifor Pharma

  • 16:40
  • 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
      Watch Session   Presentation
    Rodrigo Ruiz

    Rodrigo Ruiz Head of Country Pharmacovigilance Mexico
    Bristol-Myers Squibb

  • 17:00
  • 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.
      Watch Session
    Uwe Gudat (Moderator)

    Uwe Gudat (Moderator) Head of Medical Affairs & CSPV
    Fresenius Kabi

    Joan Francesc Aregall Picamal

    Joan Francesc Aregall Picamal Former Pharmacovigilance Country Head, Spain
    Bayer

    Sharmila Sabaratnam

    Sharmila Sabaratnam Senior Director, Vault Safety Strategy
    Veeva Systems

  • 17:30
  • Chairperson’s closing remarks

      Watch Session
    Uwe Gudat (Moderator)

    Uwe Gudat (Moderator) Head of Medical Affairs & CSPV
    Fresenius Kabi

  • 17:40
  • 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

      Watch Session
    Michael Ramcharan (Moderator)

    Michael Ramcharan (Moderator) Managing Director
    Reumat Consulting

  • 10:30
  • Globalisation of the PSMF

    • What does this mean for global MAHs?
    • How to adapt to these global requirements?
    • How could automation support?
      Watch Session
    Maria Artolazabal Cabrerizo

    Maria Artolazabal Cabrerizo PV Governance & Policy Leader - PSMF GPO
    Roche

  • 11:00
  • Impact and Use of Digital Media in Pharmacovigilance

      Watch Session
    Agata Catalano

    Agata Catalano Pharmacovigilance Manager
    Shionogi Europe

Patient Centric Pharmacovigilance

  • 11:40
  • Role of Pharmacovigilance in boosting market access

      Watch Session
    Hadir Rostom

    Hadir Rostom Consultant
    WHO

Quality and Compliance

  • 12:00
  • PV Inspections – Regulatory perspective from the Health Products Regulatory Authority

    • Overview of PV inspection programmes
    • Co-operation among the European network
    • How best to support inspections as an inspectee
    • Impact of Covid-19 and use of remote inspections
    • Common inspection findings
      Watch Session   Presentation
    Peter Twomey

    Peter Twomey GCP/PV Inspection Manager
    Health Products Regulatory Authority (HPRA)

  • 12:20
  • Virtual Luncheon & Networking - Visit Exhibitor Booths & Network with your peers in our Lounge (Face to Face Video Chats)

     

                      

  • 13:10
  • Business partner GVP audits: How to apply a risk based approach and decide the partners to audit and topics to focus on?

      Watch Session
    Tea Babic

    Tea Babic Director, PV Audits and Inspections
    Teva Pharmaceuticals

  • 13:50
  • Pharmacovigilance System: Audit & Inspection Readiness

      Watch Session
    Ahmed Abdelrahman

    Ahmed Abdelrahman Patient Safety and Pharmacovigilance Manager GulfIP
    Boehringer Ingelheim

Data & Next-Gen Technologies

  • 14:10
  • Patient-Centric Pharmacovigilance: Building Better Outcomes through Integrated Technology to monitor quality and improve patient outcomes

      Watch Session
    Raghda Mohamed

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

  • 14:30
  • CASE STUDY: Postmarket Safety Reporting for Combination Products in the US

      Watch Session
    Khaudeja Bano

    Khaudeja Bano Head of Combination Product and Device Safety, Executive Medical Director
    Amgen

  • 14:50
  • Visit Virtual Exhibitor Booths/Speed Networking at our Exclusive Lounge (Face to Face Video chat with Exhibitors and other attendees)

     

          

  • 15:10
  • Leveraging Data Analytics to predict risks to a Pharmacovigilance System

      Watch Session
    Minhaj Obeidullah

    Minhaj Obeidullah Head Compliance & Risk Management
    Novartis

  • 15:40
  • Improving patient involvement with Patient Generated Health Data

    • Benefits of Patient Generated Health Data 

    • Mobile Health Technology and potential value in Pharmacovigilance

    • Legal and regulatory considerations

      Watch Session   Presentation
    Victoria Abdala

    Victoria Abdala Head of Patient Safety & Pharmacovigilance ROPU South America
    Boehringer Ingelheim

  • 16:00
  • Safety as a strategy: Some current and emerging opportunities for pharmacoepidemiology and real-world evidence (RWE) generation to inform benefit/risk decision making

      Watch Session
    Ryan Kilpatrick

    Ryan Kilpatrick Head, 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
      Watch Session
    Michael Ramcharan (Moderator)

    Michael Ramcharan (Moderator) Managing Director
    Reumat Consulting

    Michael Glaser

    Michael Glaser Safety Innovation Technology Director
    GSK

    Yvonne Nanciu

    Yvonne Nanciu Country Head Pharmacovigilance Germany
    Bayer pharmaceuticals

    Kate Gofman

    Kate Gofman Global Safety Physician, AI & Blockchain Innovator
    AstraZeneca

    Rishi Chopra

    Rishi Chopra Senior Director, Head of International Pharmacovigilance (IPV)
    Biogen

Vendor Management and Outsourcing

  • 17:00
  • Pharmacovigilance Vendor Management

    • Procurement & Brand Teams
    • Vendor Oversight
    • Global & Local Regulations
    • Vendor Relationship Building
      Watch Session
    Dawn Mucci

    Dawn Mucci Team Lead, Patient Safety Compliance and Enablement
    AstraZeneca

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

      Watch Session
    Michael Ramcharan (Moderator)

    Michael Ramcharan (Moderator) Managing Director
    Reumat Consulting

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.

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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]

Testimonials


As a sponsor and speaker, honestly we couldn't be happier. This is the best value we've had out of a virtual event by a long way. We made connections, got leads, were seen. This was the perfect event for us and one we will definitely plan around. Thank you corvus global events for putting together such a great event.


Marketing Manager
Saphetor

VIRTUAL PLATFORM

 

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