13 — 14 June, 2019 Amsterdam

The event has already occured.

Key facts

Date: 13 — 14 June, 2019

Place: Amsterdam

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

• The NEW EudraVigilance System and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format
• Comply With FDA’s June 2018 Deadline for Combination Product Safety Reporting
• Regulatory Inspections – How can companies avoid critical and major findings?
• PSURs: Benefit-Risk Evaluations – The patient perspective
• Effectiveness checks for risk minimization measures
• The Role of QPPV
• 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
• What the New EU Data Protection Regulation (GDPR) will mean for PV?
• Good Pharmacovigilance Practices (GVP) Implementation
• Implementing and adopting global harmonization practices within a company

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
•     Data Analysis
•     Pharmacovigilance
•     Pharmacoepidemiology
•     Epidemiology
•     Clinical Data Management
•     PSMF
•     CAPA
•     QPPV
•     Medical Affairs
•     Adverse Drug Reactions
•     Drug/Product Safety
•     Drug Development
•     GPvP
•     Clinical Safety
•     Risk Management
•     Patient Safety
•     Signal Detection
•     Signal Management
•     Safety Surveillance
•     Regulatory Affairs and Compliance
•     PV Governance
•     Safety Management
•     PV Inspection and Audit Readiness
•     Medical Safety
•     Phase IV/Postmarketing Safety

Event Speakers

Rocio Castellanos

Director of Compliance


Riti S. Shah

Director of Pharmacovigilance


Catherine Harvey

Senior Director of Clinical Safety & Pharmacovigilance


Sameer Thapar

Director, Global Pharmacovigilance


Rama Diop

Head of Patient Safety, Region Africa


John Hart

Director, Pharmacovigilance & EEA QPPV

Samsung Bioepis

Ricarda Tiemeyer

Associated Director Pharmacovigilance, Head of Drug Safety


Deepa Arora

Founder and Director

Clinexel Life Sciences

Sally Chen

Pharmacovigilance Director


Mate Balazs

Country Head


Monika Manske

Associate Director, Head Pharmacovigilance Quality System


Nikolina Colak



Medhat Mahfouz

Head of Pharmacovigilance


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