ICH Information Day & Pre-Conference Tutorials

In addition to the 80+ sessions throughout the EuroMeeting programme, we have dedicated pre-conference tutorials, focused on key topics of interest for you.

View details below on the ICH Information Day and the six additional Tutorials

Supplemental Registration Required for all below events.

• ICH Info Day

  Wednesday 06 April, 08:00-12:30
  3rd ICH Information Day

  Jointly Organised by EC/EMA/DIA
  
  This year’s Information Day will focus on the recent reforms by ICH and what this means for global development of medicines. Participants will hear how ICH is moving towards becoming a truly global platform for regulators and industry to achieve the objective of ‘Harmonisation for Better Health’.
  
  Learn directly from the experts:
  Sessions include Q&A with Dawn Ronan, Director of the ICH Secretariat, Tomas Salmonson EMA, EU and Richard Bergström, EFPIA, Belgium
  

  Tutorial 1

  Wednesday 06 April, 09:00-12:30
  Introduction to the Regulation of Medical Devices and Medical Software

  Sabina Hoekstra-van den Bosch, Global Regulations and Standards, Philips Healthcare, Netherlands
  Erik Vollebregt, Attorney, Axon Lawyers, Netherlands
  
  

  Learning Objectives

  At the conclusion of this tutorial, attendees will be able to:
  

  • Understand the main characteristics of the EU medical devices regulatory system, how it operates and how to bring a medical device to market
  • Understand the delineation between pharmaceutical and medical devices
  • Learn about the regulation of medical software and medical apps
  • Discover the main changes resulting from the currently ongoing legislative review process

  Tutorial 2

  Wednesday 06 April, 09:00-12:30
  Moving from Risk Management to Benefit-Risk Management – Embedding Pharmacovigilance Principles into the Product Life Cycle

  Shelley Gandhi, Director Pharmacovigilance and Drug Safety, NDA Group, UK
  William Richardson, Medical Advisor, NDA Group, UK
  
  

  Learning Objectives

  At the conclusion of this tutorial, attendees will be able to:
  

  • Learn what are effective strategies and the current thinking on risk mitigation in the context of benefit throughout the product lifecycle. Access to robust evidence on emerging risk is critical
  • Discover what the principles are for proportionate risk based assessment
  • Find out about hurdles which get in the way to a systematic approach and how these might be tackled

  Tutorial 3

  Wednesday 06 April, 09:00-12:30
  Interactions between Regulatory and Intellectual Property, Product Liability, and Data Privacy

  Geneviève Michaux, Counsel, Hunton & Williams, Belgium
  
  

  Learning Objectives

  At the conclusion of this tutorial, participants will be able to:
  

  • Explain and discuss the basics of intellectual property, product liability, and competition rules applicable to medicinal products
  • Identify and better address the regulatory issues that present an intellectual property, product liability, or competition aspect

  Tutorial 4

  Wednesday 06 April, 09:00-12:30
  Analysis of Safety Data from Clinical Trials

  Jürgen Kübler, Global Head, Clinical Design, Analysis and Reporting, CSL Behring GmbH, Germany
  Joachim Vollmar, Executive Consultant, International Clinical Development Consultants (ICDC) LLC, USA
  
  

  Learning Objectives

  At the conclusion of this tutorial, participants will be able to:
  

  • Examine relevant guidelines and regulatory requirements for clinical trials
  • Recognise how to contribute to safety analysis plans
  • Assess statistical safety analysis and identify pitfalls in safety analysis
  • Recognise the impact of benefit-risk assessment in safety data

  Tutorial 5

  Wednesday 06 April, 09:00-12:30
  EU Risk Management Plans: Using (Pre) Clinical Data to Write the Module SVII of the RMP Part II – Safety Specifications

  Emil Andrei Cochino, DrMed, Scientific Officer, European Medicines Agency, United Kingdom
  
  

  Learning Objectives

  At the conclusion of this tutorial, participants will be able to:
  

  • Apply the risk definitions in the newly revised GVP Module V to identify the important risks of a medicinal product based on (pre)clinical findings
  • Use the RMP template for industry to write an evidence-based Module SVII of the RMP
  • Evaluate when the post-marketing safety results enable changes in the RMP

  Tutorial 6

  Wednesday 06 April, 09:00-12:30
  Hot Topic in Pharmacovigilance and Adverse Reaction Reporting

  Margaret Anne Walters, Director & Deputy EU Qualified Person for Pharmacovigilance, Merck Sharp & Dohme Ltd., United Kingdom
  Phil Tregunno, Signal Management & Quality Standards Unit Manager, MHRA, United Kingdom
  
  

  Learning Objectives

  At the conclusion of this tutorial, attendees will be able to:
  

  • Describe the principles of access to EudraVigilance based on the revised policy
  • Discuss the implementation experience and FAQs related to the new process for monitoring of medical literature by the EMA 
  • Address FAQs on GVP Module VI “Management and reporting of adverse reactions to medicinal products” and recent updates
  • Describe how to prepare for the ISO/ICH ISCR implementation