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


Patient Centric Drug Safety


Quality &

Pharmacovigilance Outsourcing

Medical Devices Safety

Adverse Drug Reactions




  • 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





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



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

  • 10:10
  • Chairperson’s opening remarks

  • 10:20
  • ARTEMIS: Transforming Adverse Event Case Processing through Automation

    Julie Girod

    Julie Girod Associate Vice President, Global Head of Case Management and Medical Evaluation

  • 10:40
  • 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 Diop

    Rama Diop Head Patient Safety Region Africa

  • 11:00
  • Augmenting decision making in PV through artificial intelligence: Drug safety professional evolving PV cyber skills

    Salvatore Giorgio Cicirello

    Salvatore Giorgio Cicirello Safety Science & PASS, Worldwide Patient Safety
    Bristol Myers Squibb

  • 11:20
  • The unmet need for medication adherence

    Mayada Alkhakany

    Mayada Alkhakany Senior Global NTA Manager
    Boehringer Ingelheim

  • 11:40
  • Booked for Sponsor - Veeva Systems

Drug Safety Strategies & Regulatory updates

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

    Andreas Osanger

    Andreas Osanger Director - Therapeutic Area Lead Nephrology
    Vifor Pharma

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



  • 13:00
  • Novel AI for Extraction of Adverse Events and Auto Generation of Adverse Event Reports

    Jingqing Zhang

    Jingqing Zhang Technical Co-founder and Head of AI
    Pangaea Data

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

    Raphael Elmadjian Pareschi

    Raphael Elmadjian Pareschi Associate Director Pharmacovigilance

Safety Signals and Risk Management

  • 13:40
  • Topic to be Announced


    ArisGlobal is a leader in pharmacovigilance software solutions. LifeSphere Safety, the unified cloud platform for end-to-end safety, embeds over 30 years of industry expertise and the most production-ready intelligent automation available. LifeSphere Safety helps teams of all sizes collect, process, and act on safety data with greater efficiency, higher-quality compliance, and deeper insights.

    Speaker To Be Confirmed

    Speaker To Be Confirmed 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

    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

    Allison Stogdale

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

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

    Uwe Gudat

    Uwe Gudat 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)



  • 15:30
  • 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 

    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
  • 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"

    Stephanie Tcherny

    Stephanie Tcherny Global Head of Benefit-Risk Evaluation

  • 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 

    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

    Rodrigo Ruiz

    Rodrigo Ruiz Head 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 Mucci

    Dawn Mucci Team Lead, Patient Safety Compliance and Enablement

  • 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 Waele

    Wivina De Waele Director EMEA, Global Drug Safety
    Alexion Pharmaceuticals, Inc

    Joan Francesc Aregall Picamal

    Joan Francesc Aregall Picamal Former Pharmacovigilance Country Head, Spain

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

    Khaudeja Bano

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

  • 10:50
  • Natural Language Processing for Adverse Event Detection: a Case Study on COVID-19 Vaccines

    Enrico Santus

    Enrico Santus Data Science Leader in Pharmacovigilance

  • 11:10
  • Impact and Use of Digital Media in Pharmacovigilance

    Agata Catalano

    Agata Catalano Pharmacovigilance Manager
    Shionogi Europe

Patient Centric Pharmacovigilance

  • 11:30
  • Designing a Patient Centred Pharmacovigilance System

    Brian Edwards

    Brian Edwards Principal Consultant
    NDA Group

  • 11:50
  • Post-marketing surveillance and Structured benefit risk

    Maria Artolazabal Cabrerizo

    Maria Artolazabal Cabrerizo PV Governance & Policy Leader - PSMF GPO

  • 12:10
  • Role of Pharmacovigilance in boosting market access

    Hadir Rostom

    Hadir Rostom Consultant

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



Quality and Compliance

  • 13:20
  • 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

    Peter Twomey

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

  • 13:40
  • Business partner GVP audits: How to apply a risk based approach and decide the partners to audit and topics to focus on?

    Tea Babic

    Tea Babic Director, PV Audits and Inspections
    Teva Pharmaceuticals

  • 14:00
  • Pharmacovigilance Audit Planning: Enhancing Efficiency for New and Existing Markets via Risk-Based Approach.

    Kishan Nandha

    Kishan Nandha PVQA Manager & Lead Auditor
    Astellas Pharma US

  • 14:20
  • Pharmacovigilance System: Audit & Inspection Readiness

    Ahmed Abdelrahman

    Ahmed Abdelrahman Patient Safety and Pharmacovigilance Manager GulfIP
    Boehringer Ingelheim

Data & Next-Gen Technologies

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

    Raghda Mohamed

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

  • 15:00
  • Visit Virtual Exhibitor Booths/Speed Networking at our Exclusive Lounge (Face to Face Video chat with Exhibitors and other attendees)



  • 15:20
  • 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

  • 15:40
  • Leveraging Data Analytics to predict risks to a Pharmacovigilance System

    Isabelle Lalande-Luesink

    Isabelle Lalande-Luesink Global Head Operational Excellence

    Minhaj Obeidullah

    Minhaj Obeidullah Head Compliance & Risk Management

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

    Ryan Kilpatrick

    Ryan Kilpatrick Head, Global Epidemiology

  • 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 Nanciu

    Yvonne Nanciu Country Head Pharmacovigilance Germany
    Bayer pharmaceuticals

    Kate Gofman

    Kate Gofman Global Safety Physician, AI & Blockchain Innovator

    Rishi Chopra

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

    Michael Glaser

    Michael Glaser Safety Innovation Technology Director

  • 17:10
  • Improving patient involvement and wearables

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

    Victoria Abdala

    Victoria Abdala Head of Patient Safety & Pharmacovigilance ROPU South America
    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

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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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]


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



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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