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Pharmacovigilance World 2022 (November 22-23, 2022)

  • Conference
  • 2 Days: November 22-23, 2022 09:30 GMT
  • Corvus Global
  • ID: 5614396

With the augmented incidence of diseases, and the non-medical use of prescription drugs, the incidence of drug abuse has increased enormously in recent years, which is apparent with the excess documentation of adversities and drug toxicities. In this context, 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, evidence suggests 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 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 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 public health. It will also allow all its participants to interact with the experts, and discuss the various developments, challenges faced, and innovations in the field.

The Pharmacovigilance conferences are known for bringing 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.


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

Time Zone - GMT

Agenda

Tuesday - 22nd November 2022 (Time Zone - GMT)

09:30 - Welcome Address & Platform Orientation - Orientation will focus on how to access and navigate the virtual conference platform for Live Sessions & Interactive Networking

09:40 - Chairperson’s opening remarks

09:50 - Assessing the Quality of ICSRs & the Impact on causality assessment and signal evaluation
Maria De Los Angeles Hernandez Loli Maria De Los Angeles Hernandez Loli Patient Safety Lead Cluster Ecuador - Peru
Boehringer Ingelheim

Drug Safety Strategies & Regulatory updates

10:15 - Women and child health care medicines and pharmacovigilance
Carla Valeria Massironi Carla Valeria Massironi CHC Country Safety Head
Sanofi

10:35 - 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
Maria Maddalena Lino Maria Maddalena Lino Safety risk Lead Director
Pfizer

11:05 - Drug Safety Evaluation Strategies
Nibha Mishra Nibha Mishra Senior Scientist
Takeda

11:25 - ICH in Brazil: New PV Regulation following Incorporation of ICH Guidelines
Raphael Elmadjian Pareschi Raphael Elmadjian Pareschi Pharmacovigilance Associate Director
MSD

Safety Signals & Risk Management

11:45 - 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

Booked for Aris Global (Platinum Sponsor) 

12:05 - 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
Ajinkya Inamdar Ajinkya Inamdar Director, Vaccines Global Safety Strategy and Risk Management
The Janssen Pharmaceutical Companies of Johnson & Johnson

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

13:00 - Risk Management Under EU Medical Device Regulation (EU MDR)

13:25 - 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
Rodrigo Ruiz Rodrigo Ruiz Senior Manager, Patient Safety
Bristol-Myers Squibb

13:50 - Global considerations for periodic reports, benefit risk management and risk minimisation and the lifecycle implications (Topic TBC)
Robert Massouh Robert Massouh Director - Risk Management Product Lead
Pfizer

Quality & Compliance

14:15 - Pharmacovigilance System: Audit & Inspection Readiness
Sales, information and knowledge of consumers
Awareness, generic names, reduction of medication errors in private clinics
Industrial association
Raj K Bhogal Raj K Bhogal Senior Director, R&D Audits & Inspections
Jazz Pharmaceuticals

14:40 - Reason, Scope and Significance of establishing good PV system

15:05 - What are the key steps for establishing and maintaining compliance with all applicable internal and external requirements and regulations

15:30 - Visit Virtual Exhibitor Booths/Speed Networking at our Exclusive Lounge (Face to Face Video chat with Exhibitors and other attendees)

15:50 - Pharmacovigilance Audit Inspection & Quality systems
Valentina Mancini Valentina Mancini Director Pharmacovigilance, EU and UK QPPV
Shionogi

16:15 - International harmonization and drug regulatory requirement

Advanced therapy medicinal products (ATMPs) and PV

16:40 - Advanced therapeutic techniques and pharmacovigilance
Advanced therapeutic techniques and pharmacovigilance
Challenges related with monitoring and safety
Benefit-risk assessment of ATMP
Retesh Kumar Retesh Kumar Director, Global Pharmacovigilance, Therapeutic Area Lead- Cardio Renal
Otsuka Pharmaceutical Companies (U.S)

17:05 - Major developments in regulatory framework
The future of gene therapy, stem-cell therapy, and tissue engineering
EU guidelines and updates - Good Manufacturing Practices for ATMPs

Outsourcing & Vendor Management

17:30 - Developing Value-Based Partnerships
Establishing a clear understanding of the goals and objectives of the partnership
Defining the roles and responsibilities of each partner
Negotiating and formalizing agreements between partners
Monitoring and evaluating the partnership performance on an ongoing basis
Cinthya Galicia Quintanar Cinthya Galicia Quintanar Senior Manager, Country Safety Lead
Pfizer

17:55 - Build Effective Metrics for Vendor Oversight
Julia Appelskog Julia Appelskog EU QPPV, Head of EU QPPV Office
Novavax

18:20 - Chairperson’s closing remarks

18:30 - Virtual Networking - Catch-up with your peers in social lounge

Wednesday - 23rd November 2022 (Time Zone - GMT)

09:30 - Welcome Address & Platform Orientation - Orientation will focus on how to access and navigate the virtual conference platform for Live Sessions & Interactive Networking

09:40 - Chairperson’s opening remarks

09:50 - Improving the quality of your adverse event reporting system (Topic TBC)
Santiago Schiaffino Santiago Schiaffino Head of PV Systems and Standards / Deputy EUQPPV
Boehringer Ingelheim

10:15 - Service provider Presentation

Automation, AI & Data Management

10:35 - Impact of AI & Machine learning on Pharmacovigilance and Drug Safety
Ever expanding data and its safety
Importance and application of AI
Improving speed, accuracy and reliability using AI
Robert Di Giovanni Robert Di Giovanni Global Project Safety Lead
Novartis

11:00 - Automation and pharmacovigilance: identifying risk factors for AEs
Michael Von Forstner Michael Von Forstner Global Head of Clinical Safety and Pharmacovigilance
Biogen

11:25 - Improving Drug Safety with Adverse Event Detection using NLP

11:50 - Improving patient involvement and wearables
Role of internet/ communication techniques, advertisement
Post-market surveillance of devices
Therapeutic good administration
Safety management
Yvonne Nanciu Yvonne Nanciu Country Head Pharmacovigilance Germany
Bayer

12:15 - 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

12:35 - Virtual Luncheon & Networking - Visit Exhibitor Booths & Network with your peers in our Lounge (Face to Face Video Chats)

13:05 - Leveraging Data Analytics to predict risks to a Pharmacovigilance System
Minhaj Obeidullah Minhaj Obeidullah Head Compliance & Risk Management
Novartis

13:30 - Artificial Intelligence in Medical Device

Booked for Gavion Technologies

13:55 - Pharmacoepidemiology and Real-World Evidence (RWE) generation

14:20 - Panel Discussion - The future of pharmacovigilance: How technology will change the way we monitor drugs
The future of pharmacovigilance will be more automated
AI will play a big role in data management and analysis
The use of technology will increase speed and accuracy
Yvonne Nanciu Yvonne Nanciu Country Head Pharmacovigilance Germany
Bayer

Case Processing & Patient Centric Approach

14:50 - Importance of Quality Case Processing in Pharmacovigilance
Laura Arce Mora Laura Arce Mora Country Safety Lead
Pfizer

15:15 - AI & Machine Learning for Automated Case Processing in Pharmacovigilance

15:40 - Visit Virtual Exhibitor Booths/Speed Networking at our Exclusive Lounge (Face to Face Video chat with Exhibitors and other attendees)

16:00 - Partnership arrangements to speed up case processing times, improve data quality, and reduce costs are an essential part of ensuring the safety of drugs and protecting patients' health
Victoria Bartasek Victoria Bartasek Senior Associate Director, Global Pharmacovigilance Operations
Boehringer Ingelheim

16:25 - Designing a Patient Centred Pharmacovigilance System

16:50 - Chairperson’s closing remarks & End of Conference

Speakers

Robert Massouh
Director - Risk Management Product Lead
Pfizer

Robert Di Giovanni
Global Project Safety Lead
Novartis

Raj K Bhogal
Senior Director, R&D Audits & Inspections
Jazz Pharmaceuticals

Rodrigo Ruiz
Senior Manager, Patient Safety
Bristol-Myers Squibb

Ajinkya Inamdar
Director, Vaccines Global Safety Strategy and Risk Management
The Janssen Pharmaceutical Companies of Johnson & Johnson

Maria Maddalena Lino
Safety risk Lead Director
Pfizer

Michael Von Forstner
Global Head of Clinical Safety and Pharmacovigilance
Biogen

Laura Arce Mora
Country Safety Lead
Pfizer

María De Los Ángeles Hernández Loli
Patient Safety Lead Cluster Ecuador - Peru
Boehringer Ingelheim

Valentina Mancini
Director Pharmacovigilance, EU and UK QPPV
Shionogi

Victoria Bartasek
Senior Associate Director, Global Pharmacovigilance Operations
Boehringer Ingelheim

Who Should Attend

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