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
  • ARTEMIS: Transforming Adverse Event Case Processing through Automation

    Julie Girod

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

  • 10:50
  • 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

  • 11:10
  • 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

  • 11:40
  • The unmet need for medication adherence

    Mayada Alkhakany

    Mayada Alkhakany Senior Global NTA Manager
    Boehringer Ingelheim

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
  • 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?

    Shahinaz Badr

    Shahinaz Badr Regional Pharmacovigilance Manager
    NewBridge Pharmaceuticals

  • 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
  • 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 Zampatis

    Dimitris Zampatis Head of Pharmacovigilance EMEA-EEA QPPV

  • 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
    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
  • Solution Provider Presentation

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

  • 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 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

    Valentina Mancini

    Valentina Mancini Director Pharmacovigilance, EU and UK QPPV
    Shionogi Europe

Data Management & Analytics in PV

  • 11:30
  • 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

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

    Maria Artolazabal Cabrerizo

    Maria Artolazabal Cabrerizo PV Governance & Policy Leader - PSMF GPO

  • 12:10
  • Designing a Patient Centred Pharmacovigilance System

    Brian Edwards

    Brian Edwards Principal Consultant
    NDA Group

  • 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
  • Reason, Scope and Significance of establishing good PV system

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

    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

Next-Gen Technologies & PV

  • 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

  • 17:00
  • Improving patient involvement and wearables

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

    Victoria Abdala

    Victoria Abdala ROPU South America Pharmacovigilance Head
    Boehringer Ingelheim

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

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