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.
Conference Overview
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 2022 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 2022 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 2022
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
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 speaker@corvusglobalevents.com
Mulugeta Russom
Pharmacoepidemiologist and Pharmacovigilance Specialist Head
Eritrean Pharmacovigilance Centre
Siva Kumar
Global Phv Surveillance Physician Sr Manager, Medical Scientific Unit
Teva Pharmaceuticals
Zeljana Margan Koletic
Head of Pharmacovigilance and Rational Pharmacotherapy Department
Agency for Medicinal Products and Medical Devices
Tea Babic
Director, Head of PV Audits and Inspections Deputy Head of PV Compliance Global Patient Safety and Pharmacovigilance
Teva Pharmaceuticals
Siddhant Ekale
Enterprise Architect – Clinical Data Management
Tuesday - 22nd November 2022 (Time Zone - GMT)
- 09:20
-
Welcome Address & Platform Orientation - Orientation will focus on how to access and navigate the virtual conference platform for Live Sessions & Interactive Networking
- 09:35
-
Chairperson’s opening remarks
Watch Session
Michael Ramcharan Managing Director
Reumat Consulting
- 09:45
-
Ways to build successful PV partnerships in in-licensing scenarios and the role of PV in due-diligence processes
Watch Session Presentation
Andreas Osanger Director - Therapeutic Area Lead Nephrology
CSL Vifor
- 10:15
-
Review of aRMM effectiveness measures in Europe
Watch Session Presentation
Robert Massouh Director - Risk Management Product Lead
Pfizer
- 10:45
-
Benefit-risk assessment of isoniazid preventive therapy in people living with HIV in Eritrea
Watch Session Presentation
Mulugeta Russom Pharmacoepidemiologist and Pharmacovigilance Specialist Head
Eritrean Pharmacovigilance Centre
Drug Safety Strategies & Pharmacovigilance
- 11:10
-
Panel Discussion - 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
Michael Ramcharan Managing Director
Reumat Consulting
Andreas Osanger Director - Therapeutic Area Lead Nephrology
CSL Vifor
Siva Kumar Global Phv Surveillance Physician Sr Manager, Medical Scientific Unit
Teva Pharmaceuticals
Siddhant Ekale Enterprise Architect – Clinical Data Management
- 11:45
-
Women and child health care medicines and pharmacovigilance
Watch Session Presentation
Carla Valeria Massironi CHC Country Safety Head
Sanofi
Safety Signals & Risk Management
- 12:10
-
Risk minimization and management
- Assessment with comprehensive data quality
- Compliant safety system (GxP compliant, inspection-ready system)
- Safety signals, effective trials, strategic risk assessment decisions
Klaudija Marijanovic Barac EU & UK QPPV deputy
Teva Pharmaceuticals
- 12:35
-
Virtual Luncheon & Networking - Visit Exhibitor Booths & Network with your peers in our Lounge (Face to Face Video Chats)
- 13:15
-
Risk management in Mexico: challenges and opportunities
Watch Session Presentation
Rodrigo Ruiz Senior Manager, Patient Safety
Bristol-Myers Squibb
- 13:40
-
Fireside Chat - REMS Compliance and Inspection Readiness
Watch Session
Michael Ramcharan Managing Director
Reumat Consulting
Nancy Dubois Head of Global Patient Safety US Region
EMD Serono, Inc.
Kal Elhoregy Director, Risk Evaluation and Mitigation Strategies
Amneal Pharmaceuticals
Iva Galic Pharmacovigilance Inspector Expert
HALMED
- 14:10
-
Assessing the Quality of ICSRs & the Impact on causality assessment and signal evaluation
Watch Session
Maria De Los Angeles Hernandez Loli Patient Safety Lead Cluster Ecuador - Peru
Boehringer Ingelheim
- 14:40
-
Case Study: Additional Risk Minimisation Measures from planning to execution
Watch Session
Eman Gomaa MEA PV Hub Lead
AbbVie
- 15:05
-
Visit Virtual Exhibitor Booths/Speed Networking at our Exclusive Lounge (Face to Face Video chat with Exhibitors and other attendees)
- 15:20
-
The Safety Platform of Tomorrow in Production Today: Advancing Patient Safety through Innovation and Intelligence
Watch Session
Beena Wood Senior Vice President, Product Marketing
ArisGlobal
Elizabeth Smalley Director, Product Management, Data & Analytics
ArisGlobal
Quality Assurance and Regulatory Compliance
- 15:50
-
Why pharmacovigilance sometimes fails and how to bridge the gaps?
Watch Session Presentation
Nancy Dubois Head of Global Patient Safety US Region
EMD Serono, Inc.
- 16:15
-
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
Tea Babic Director, Head of PV Audits and Inspections Deputy Head of PV Compliance Global Patient Safety and Pharmacovigilance
Teva Pharmaceuticals
- 16:40
-
Cross-Functional Initiatives for Safety, Risk Management, and Pharmacovigilance Activities Across the Product’s Lifecycle
- Increase transparency and improve awareness in your communication for Safety, Risk Management, and Pharmacovigilance across the product’s lifecycle
- Bring value to cross functional approaches within safety governance (SMT and SAC), preparing aggregate reports (DSUR/ PBRER), safety surveillance and core data sheet etc.
Outsourcing & Vendor Management
- 17:05
-
Build Effective Metrics for Vendor Oversight
Watch Session Presentation
Julia Appelskog EU QPPV, Head of EU QPPV Office
Novavax
- 17:30
-
Safety-Radar: towards autonomous reasoning in investigative toxicology. Including patients' genetics data in assessments of adverse events
- Architecture of Safety-Radar – a system for evaluating drug safety.
- The platform will support automated reasoning and serendipitous discovery of new 'facts' or interesting and testable hypotheses
- Strategies of how to integrate and provide high-value AI-ready data sources and how to develop (semi) autonomous reasoning agents.
Marcin Von Grotthuss Associate Director, Machine Learning
Takeda
- 17:55
-
Chairperson’s closing remarks
Watch Session
Michael Ramcharan Managing Director
Reumat Consulting
- 18:05
-
Virtual Networking - Catch-up with your peers in social lounge
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 delegate@corvusglobalevents.comfor more details.
SPONSORSHIPS
Maximise Your Involvement through Sponsorship and Exhibition Opportunities
Our Sponsors are an integral part of the CGE Conference and we want to ensure you receive the best possible
results for your investment.
Exhibiting and Sponsorship options are extensive, and packages can be tailor-made to suit your individual
company's needs. Most packages include complimentary entry passes, targeted marketing to industry officials
and executives, and bespoke networking opportunities.
For enquiries please e-mail to
sponsor@corvusglobalevents.com
Platinum Sponsor
ArisGlobal
Associate Sponsor
Gavion Technologies
PARTNERS
Partnerships typically involve an exchange of value and frequently include online content, PR, advertising,
online & event branding.
For enquiries please e-mail to mediapartner@corvusglobalevents.com
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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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