Available on-demand (Originally presented on 16 March 2021) 

Overview

Just as xEVMPD did for Regulatory Affairs and Pharmacovigilance before it, IDMP will drive companies to evolve from a document-based world to a more structured, data driven world.  IDMP will present a significant paradigm shift. Are you ready?

With IDMP Implementation Guide V2 to be released in Q1 2021 and submission availability in Q1 2022, IDMP is a driving force that cannot be taken for granted. During this webinar, we will address important steps your organisation can take to drive readiness through 4 key pillars: 

• Data & Governance
• Technology
• Processes
• Change Management 

This webinar is sponsored by Accenture.



Disclaimer
Whilst TOPRA is running this webinar for Accenture, this is not an endorsement of Accenture, Accenture's affiliates, employees or its products and services. TOPRA is also not responsible for the content or views expressed during the webinar.

Learning objectives

The session will take you through the challenges, risks as well as opportunities of complying with IDMP in such a short timeframe:

• Challenges: Some companies will only hold the data in an unstructured format, on disparate/isolated systems, and under the guardianship of employees who may be oblivious to the requirement
• Risks: Expediting the transition could result in systems and processes that are inadequate, insecure, unreliable or not future-proofed if not managed well
• Opportunities: Interconnecting people and information on such a grand scale, when done correctly, is a prime driver for master data management which will inherently lead to greater efficiency, collaboration, insight and innovation. 

Suitable for

• Compliance
• IDMP
• Regulatory Affairs

Speakers

Regulatory Affairs Project Manager, Accenture

Kulvi Chana is a Regulatory Affairs  Project Manager within Accenture’s Accelerated R&D practice bringing 13 years of broad regulatory experience. 

Prior to joining Accenture, Kulvi worked as a consultant for Reckitt Benckiser (UK affiliate) being responsible for post approval activities, life cycle management and compliance projects for over 80 established products. At Wyeth (now Pfizer) Kulvi also played a lead role in the first registrations of leading products in the inflammation, haemophilia, infective diseases and oncology therapeutic areas in key growth areas of Russia and the CEE/CIS region.

Kulvi also has experience in the Clinical Trials domain having led Compassionate Use Programs for Gilead Sciences, CTA submissions in the EU and more recently at Accenture on the Policy 0070 Data Transparency compliance projects. Kulvi provided SME support on a Labelling Transformation project for the creation/update of core safety information across the client’s product portfolio.

Jarryd Chen
Consultant, Accenture

Jarryd is a Consultant at Accenture focused on supporting regulatory affairs client digitally transform their operating model to support the move towards a data-driven regulatory landscape. He specializes in Regulatory Information Management (RIM) and have worked on large-scale RIM implementations. Jarryd is also an IDMP SME focused on enabling IDMP compliance through the use of technology and automation.

CPD

This webinar provides 1 CPD hour upon successful completion. To learn more about why Continuing Professional Development is important, visit our Lifelong Learning page.

How do I register?

Simply log in or create an account and register below.

Pricing

• Members: Free
• Non-members: Free

Terms and Conditions

By purchasing this webinar, you are agreeing to TOPRA's training terms and conditions.