Global Drug Safety & Pharmacovigilance Summit 2024

Advancing Patient Safety Through Vigilance and Innovation

21 — 22 November, 2024 Berlin

The event has already occured.

Key facts

Date: 21 — 22 November, 2024

Place: Berlin

Conference Overview

The stringent regulations on safety monitoring increased the safety in data collection, analysis and regulatory surveillance. Adding to this the rising demand for drugs, the amplified need for novel therapeutics development via extensive clinical trials and the world population growth made drug manufacturers to start to pay more attention to Pharmacovigilance as public anxiety about safety increases.

Furthermore, the growth of exponential rare and chronic disease contributed to an increased need for drug development, therefore this led the industry to have a bigger focus on drug safety.

On this B2B event participants will have the chance to learn more about this challenging era and the latest developments in Pharmacovigilance and Drug Safety with the main key players in this field.

This event will be focusing on trends on Regulatory challenges, Signal detection, Data management, Risk management, Audit & Inspection and New technology applied to Pharmacovigilance procedures.

We invite you to discuss and debate these challenges in a dialogue amongst top professionals in Pharmacovigilance.

Key topics

  • Regulatory Inspections – How can companies avoid critical and major findings?
  • What GVP auditors currently focus on?
  • Increase transparency and heighten operational standards to ensure accurate ADR detection
  • Applying data analytics in Pharmacovigilance processes to increase the speed of signal detection
  • Ensuring data integrity and Compliance with CGMP
  • Good Pharmacovigilance Practices (GVP) Implementation
  • Improving Signal surveillance
  • Artificial Intelligence in Signal Detection
  • Combination products – Regulation, trials, and risk management
  • The role of data mining in Pharmacovigilance and its benefits
  • IDMP standards and strategy
  • Developing a pharmacovigilance risk management plan with a risk minimization action plan (RiskMAP) for high risk products
  • Understanding how Artificial Intelligence is transforming pharmacovigilance
  • Evaluation of quality and manufacturing in production
  • Audits and Inspections
  • Strengthening Pharmacovigilance quality management system
  • Impact of AI in Pharmacovigilance
  • Upcoming regulatory changes

Who should attend

CEOs / Presidents / MDs, CCOs/CMOs/CDOs, Chief Executives, Directors, Vice Presidents, Department Heads, Leaders, and Managers specialising in:

  • Assurance & Compliance
  • Quality Assurance
  • Quality Control
  • Data Analysis
  • Pharmacovigilance
  • Pharmacology
  • Pharmacoepidemiology
  • Epidemiology
  • Medical Information
  • Health Outcomes
  • PSUR/PBRER
  • Clinical Data Management
  • MedDRA
  • PV Agreements
  • PASS/PAES
  • PSMF
  • CAPA
  • QPPV
  • Medical Affairs
  • Adverse Drug Reactions
  • Drug/Product Safety
  • Drug Development
  • RMPs
  • GPvP
  • ICH-GCP
  • Clinical Pharmacology
  • Clinical Safety
  • Clinical Trials
  • Clinical Trial Management
  • Clinical Development
  • Clinical Research
  • Risk Management
  • Research & Development
  • Patient Safety
  • Signal Detection
  • Signal Management
  • Safety Surveillance
  • Safety Databases
  • Safety Evaluation
  • Outcome Research
  • Regulatory Affairs and Compliance
  • Data management and data mining
  • Benefit-Risk Assessment
  • Regulatory Submissions
  • PV Governance
  • Safety Management
  • Pharmacovigilance Operations
  • PV Inspection and Audit Readiness
  • Patient Support Programs
  • Medical Safety
  • Medical Product Safety Assessment
  • Phase IV/Postmarketing Safety

Target audience

  • International and regional health authorities and regulators
  • Pharmaceutical, Vaccines, & Biotechnology companies
  • Clinical Research Organization (CRO) service providers
  • Business Process Outsourcing (BPO) service providers
  • Risk Management Software developers
  • Pharmacovigilance Audit Firm
  • Pharmacovigilance consultancy service providers
  • Contract Research Organisations
  • Adverse Event/Case Management Service Providers
  • Safety Database Providers for Case Management
  • Healthcare/Pharmacovigilance Consultants
  • Healthcare Translation Agencies
  • Technology Vendors/Portal Service Providers

Event Speakers

Erika Barbarosie

Associate Director PV Compliance

Gilead Sciences

David Genoux

Associate Director - Pharmacovigilance Quality Risk Management

Bristol Myers Squibb

Michael Glaser

Safety Innovation Technology Director

GlaxoSmithKline

Monika Manske

Pharmacovigilance Quality Management and Deputy EEA QPPV

Viatris

Daniela Santos

Head Global Drug Safety Hub

CSL Behring

Gurpreet Singh

Vice President, Managing Director Integrated Safety

IQVIA

Michael Braun-Boghos

Senior Director Safety Strategy

Oracle

Valentina Mancini

Senior Director Pharmacovigilance - QPPV

Shionogi Europe

Mariana Calzada Mijangos

CHC Country Safety Head

Sanofi

Mina Awad

Pharmacovigilance Senior Manager and QPPV

Kyowa Kirin International plc.

Eleazar Coba Alcala

PV Officer

Bayer

Aleksandar Cakić

Pharmacovigilance and Regulatory Affairs Manager

Berlin-Chemie Menarini

María Miranda-García

Director Medical Safety

BioNTech SE

Peter Rudd-Clarke

Partner

Osborne Clarke LLP

Event location

The Conference will be taking place at Hotel Bristol Berlin

Kurfürstendamm 27, 10719 Berlin, Germany

Hotel website

Silver Sponsor

Companies attending the conference

Media Partners

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