Sharing Regulatory Intelligence: Best Practices and Case Studies

Transcription

1 Sharing Regulatory Intelligence: Best Practices and Case Studies Carolyn Hynes Sr. Director, Global Regulatory Intelligence, GlaxoSmithKline 26th Annual EuroMeeting March 2014 ACV, Vienna Austria

2 Disclaimer The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Drug Information Association, Inc. ( DIA ), its directors, officers, employees, volunteers, members, chapters, councils, Special Interest Area Communities or affiliates, or any organization with which the presenter is employed or affiliated. These PowerPoint slides are the intellectual property of the individual presenter and are protected under the copyright laws of the United States of America and other countries. Used by permission. All rights reserved. Drug Information Association, DIA and DIA logo are registered trademarks or trademarks of Drug Information Association Inc. All other trademarks are the property of their respective owners.

3 Overview What is Regulatory Intelligence (RI); what are its challenges? Tools for sharing RI and how these are evolving over time Data suggesting trend to move away from newsletters towards other tools Case study- Company RI system developed in 2012 Key features and aims

4 Introduction Definition of RI the act of processing targeted information and data from multiple sources, analysing the data in its relevant context and generating a meaningful output- e.g. outlining risks and opportunities- to the regulatory strategy. The process is driven by business needs and linked to decisions and actions ;

5 Introduction Why Regulatory Intelligence? Pharmaceutical industry heavily regulated Companies operating globally & need to be compliant New legislation/guidelines cannot be ignored, whether local or regional Complex environment, ever increasing changing/new requirements Influence future regulatory framework

6 Challenges for RI Professionals Ever increasing growth of information Regulatory Authority transparency initiatives EMA sharing information on medicines during various stages of MA process; meetings and workshops; other outcomes Regional differences External regulatory environment across the Globe Information flow

7 RI function and tools Over last ten years there has been a strong trend towards companies having a dedicated regulatory intelligence function Target audience defined Challenge to ensure the knowledge is disseminated effectively Appropriate tools

8 Overview What is Regulatory Intelligence (RI); what are its challenges? Tools for sharing RI and how these are evolving over time Data suggesting trend to move away from newsletters towards other tools Case study- Company RI system developed in 2012 Key features and aims

9 Tools for Communicating RI 2009 survey of RING member companies 10/12 companies produce a newsletter; most circulated at least monthly and running to several pages Multiple regions or global in scope Key health authority websites, trade associations; plus conference and workshop reports Primary audience Regulatory Affairs function

10 Tools for Communicating RI Looking over 3 year period amongst RING member companies Newsletters continue to be used, but less common Increasing use of internal collaboration sites and dedicated alerts Reasons may include Increased information Newsletters resource intensive to produce Development of new technology and platforms; tools that allow user to select preferences

11 Overview What is Regulatory Intelligence (RI); what are its challenges? Tools for sharing RI and how these are evolving over time Data suggesting trend to move away from newsletters towards other tools Case study- Company RI system developed in 2012 Key features and aims

12 Case Study Creation of an internal company site for Regulatory Intelligence Global scope, primarily Rx focused Content from External sources, e.g. regulatory authority websites Industry association groups Internally authored reports, analyses and summaries Links to other tools and databases

13 Drivers Deliver value-added content Digest, analysis and internal action Improve operational efficiency Reduce reliance on multiple distribution lists Facilitate compliance activities Record of intelligence communication

14 Key Features Place for sharing news and information about the external regulatory environment Repository for internally authored reports, metrics, analyses Alerting function Users receive RI news direct into their Inbox Guidance tracker Tool to keep track of draft guidelines under review Search function

15 Example of an alert GRI Alert Center FOR INFORMATION: highlights from... has been added Modify my alert settings View FOR INFORMATION: highlights from... View Posts Mobile View Title: FOR INFORMATION: highlights from the December 2013 PRAC meeting (9 December 2013) Body: The EMA has published the highlights of the PRAC meeting held 2-5 December, A link to the highlights document can be found here. PRAC has started an in-depth review of Iclusig (ponatinib) as a further step in assessing the risk of blood clots/arterial blockage associated with this medicine. Iclusig is used to treat patients with chronic myeloid leukaemia (CML) or acute lymphoblastic leukaemia (ALL) in patients who are Philadelphia-chromosome positive (Ph+) who cannot tolerate or do not respond to dasatinib or nilotinib. It is also used in patients who have the T315I mutation. The review was triggered at the request of the Commission under Article 20 of Regulation 726/2004. Further details here. The minutes of this meeting will be published in January The full agenda can be found here.

16 Roll out of system Intent to have a system that didn t require Training to use Awareness sessions Highlight key features Drivers Answer questions Position the system compared with other internal tools

17 Future Feedback over last 6 months from customers has been positive Plans for 2014 include developing new content Survey planned to gather input from our customers

18 Concluding remarks Regulatory intelligence has many challenges The right tools can make a difference Reach wide audience in timely manner Easy access to key documents and resources Seek input as developed Continue to evolve to meet customer needs