DAY 1: Global regulatory environment (16 May)

This session looks at the changing global regulatory framework, considers some of the challenges brought by new technologies and the importance of developing successful global and European regulatory strategies.

Time Content
9:00 Welcome and introduction

Session 1: India's role in the global environment

  • India's current regulatory framework
  • Developments and challenges
  • Global role
10:30 Break

Session 2: Key regulatory challenges

  • ATMP
  • MedTech
  • Drug-Device Combination Products
12:15 Lunch

Session 3: Developing a successful regulatory strategy

  • Importance of developing global strategy
  • How it is approached in speakers company (possible case study)
  • Challenges/ how close to a global strategy are we?
  • Key aspects to be considered in Europe

Session 4: International Council for Harmonization of technical requirements for pharmaceuticals for human use (ICH)

  • International expansion
  • ICH topics of importance to Indian regulatory environment
15:15 Break

Session 5: Role and development of regulatory profession

  • Role of the regulatory professional
  • Competency frameworks
  • Developing tomorrow's leaders
  • Upskilling to meet challenges of new technologies and changing regulatory environment
16:45 Round table — your opportunity to ask our experts questions
17:30 Close and networking event



DAY 2: Bringing products into Europe (17 May)

This session will provide insight into the current European regulatory systems and will look at the impact of proposed changes in areas such as clinical trials and devices.

Time Content

Session 1: Understanding the European Regulatory Framework

Overview of the EU regulatory framework

  • Overview of EU framework (and why it is so complex)
  • The EMA, national regulatory agencies and commission role
  • Innovation and adaptive pathways

Overview of the EU framework for medical devices regulation

Current regulatory framework:

  • CE marking
  • The role of the Notified Body

Proposed regulatory framework:

  • Changes from the current system
  • Challenges with implementation
10:00 Break

Session 2: Developing and marketing products in Europe. A practical perspective!

Conducting clinical trials in the EU

  • The current and proposed CT framework
  • Contents of a clinical trial application
  • QMS and inspections

Gaining a marketing approval: an overview of the European regulatory procedures and the factors for success

  • The centralised, decentralise and national procedures
  • Overview of the CTD
  • MA holder requirements within the EU
12:00 Lunch

Session 3: Interacting successfully with the agencies

Interacting with the agencies: An agency perspective

  • Scientific advice throughout development
  • Parallel SA with HTA
  • Hearings and appeals

Interacting with the agencies: An industry perspective

  • How to manage and prepare for scientific advice

Session 4: Post approval and compliance

Post approval requirements for marketing authorisations in Europe

  • The process for variations
  • Managing your marketing authorisation
  • Compliance and change control
14:45 Session 5: Panel Discussion and questions with today’s speakers and wider panel
15:30 Close

Programme subject to change

Speakers and panel members:

  • Dr Siu Ping Lam, Director, Licensing Division MHRA
  • Arun Mishra, Executive Vice President, Regulatory Affairs (Indian Sub Continent) GSK Consumer Healthcare Ltd
  • Margareth Jorvid, Methra Uppsala AB, LSM Group
  • Thomas Kuhler PhD, Head Global Regulatory Science & Policy EU/AMESA, Sanofi
  • Bob Clay, former Vice President Regulatory Affairs, Astra Zeneca; current President of TOPRA
  • Aileen Fisher, Vice President, Head of Regulatory Affairs and Pharmacovigilance, Kinapse
  • Tacye Connolly, Director of Policy, TOPRA
  • Dr Florence Bine-Schenk, Senior Medical Director, VCLS (previously ANSM)
  • Shaila Choi, Associate Director Regulatory Affairs AbbVie
  • Sadiq Basha, Vice President - Regulatory Affairs Strides Shasun