3rd Annual Pharmacovigilance & Drug Safety Summit

Staying up to date with Regulation, Signal and Risk Management during the Covid-19 Pandemic

25 — 26 March, 2021 Berlin

Register now

Key facts

Date: 25 — 26 March, 2021

Place: Berlin

Register now

Conference Overview

As Pharmacovigilance systems are changing significantly around the world, it is very important companies remain updated at all times. 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 field as public anxiety about safety increases.

Furthermore the growth of artificial intelligence and combination products, signal management is ever more important. It is important to meet the right people and understand the regulatory changes with IDMP, combo products as well as being prepared for inspections and audits.

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

  • Impacts of PV on Covid-19
  • 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
  • Signal management
  • Application of data analytics in Pharmacovigilance processes to increase speed of signal detection

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

Event Speakers

ISRAEL GUTIERREZ

VP Pharmacovigilance and Drug Safety

Geron

DR. MONIKA MANSKE

Associate Director, Global Pharmacovigilance Governance, Head Pharmacovigilance Quality System

Mylan Healthcare

SHUPING YANG

Senior Director Clinical Development

Inovio Pharmaceuticals

CLAUDIA NOLTE

Director, Global PVQA

CSL Behring

YVONNE NANCIU

Senior Manager Pharmacovigilance & Medical Information

AbbVie

ANDREA OLIVA

Head of Pharmacovigilance

Mylan

MICHAEL GLASER

Innovation Technology Director

GlaxoSmithKline

ALEXANDRA ARGYRAKI

Country Safety Head

Sanofi

DR. MATE A. BALAZS M.D.

Country Head – Patient Safety

Novartis

DENNIS VAN LIEW

Head, Business Development EMEA and APAC Drug Safety Solutions

Bioclinica

ROBERT WEBER

Senior Product Strategy Manager

Oracle

MICHAEL VON FORSTNER

Senior Director Patient Safety - Benefit Risk Management

PRA Health Sciences

MARIE AAVANG GEIST

Head of Clinical Safety

Orphazyme

TARAK THAKKER

Head of PV Intake

RX Logic

DR. SUMIT MUNJAL

Vice President, Global Patient Safety Evaluation

Takeda Pharmaceuticals

Companies attending the conference

Conference Tickets

For any enquiry on regards to special offers & group discounts please contact us directly at: info@globalbsg.com

€1699

Delegate package + VAT Register now

€499

Online documentation Register now

€850

Virtual Delegate package Register now

Pictures from previous events

Video from previous events

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