CONFIDENTIAL ©2014 PAREXEL INTERNATIONAL CORP. ALL RIGHTS RESERVED. REGULATORY INTELLIGENCE: INDUSTRY’S BEST PRACTICE OMICS 5 th International Pharmaceutical Regulatory Affairs, August 2015, Orlando, Florida, USA Presented by: Mariam Aslam

CONFIDENTIAL ©2014 PAREXEL INTERNATIONAL CORP. ALL RIGHTS RESERVED. / AGENDA Introduction Definition of Regulatory Intelligence (RI) Analysis of Definition Summary 2

CONFIDENTIAL ©2014 PAREXEL INTERNATIONAL CORP. ALL RIGHTS RESERVED. / INTRODUCTION Regulatory Intelligence (RI or reg intel) is likely to have been practiced in some way or other from when regulations first came in to existence. In the recent years, RI has become more of a phenomenon in the pharmaceutical regulatory sector. Although the brilliance of this concept is still evolving, two definitions have been created for RI by: - the Drug Information Association’s Regulatory Intelligence Network Group (DIA RING) - the EU Regulatory Intelligence Group (EU RING). 3

CONFIDENTIAL ©2014 PAREXEL INTERNATIONAL CORP. ALL RIGHTS RESERVED. / ‘The act of gathering and analyzing publicly available regulatory information. This includes communicating the implications of that information, and monitoring the current regulatory environment for opportunities to shape future regulations, guidance, policy, and legislation.’ ‘Regulatory intelligence is the act of processing targeted information and data from multiple sources, analyzing 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.' THE DIA RING DEFINITION 4 DEFINITION OF REGULATORY INTELLIGENCE (RI) THE EU RING DEFINITION

CONFIDENTIAL ©2014 PAREXEL INTERNATIONAL CORP. ALL RIGHTS RESERVED. / ANALYSIS OF DIA RING DEFINITION THE NEXT SLIDES WILL DISCUSS THE DEFINITION IN FRAGMENTS. 5

CONFIDENTIAL ©2014 PAREXEL INTERNATIONAL CORP. ALL RIGHTS RESERVED. / ANALYSIS OF DIA RING DEFINITION The act of gathering and analyzing publicly available regulatory information. This includes communicating the implications of that information, and monitoring the current regulatory environment for opportunities to shape future regulations, guidance, policy, and legislation.’ 6

CONFIDENTIAL ©2014 PAREXEL INTERNATIONAL CORP. ALL RIGHTS RESERVED. / ANALYSIS OF DIA RING DEFINITION The act of gathering and analyzing publicly available regulatory information. Publicly available regulatory information: - Regulatory Authority websites (e.g. EMA, FDA, TGA and NCA) - Regulatory Journals/Newsletters - Conferences/meetings - Consultants/colleagues - Groups on LinkedIn - Executing a gap analysis (what data is available, what is missing) - Conducting Regulatory surveys (asking a serious of regulatory implication questions) 7

CONFIDENTIAL ©2014 PAREXEL INTERNATIONAL CORP. ALL RIGHTS RESERVED. / ANALYSIS OF DIA RING DEFINITION The act of gathering and analyzing publicly available regulatory information. This includes communicating the implications of that information, and monitoring the current regulatory environment for opportunities to shape future regulations, guidance, policy, and legislation.’ 8

CONFIDENTIAL ©2014 PAREXEL INTERNATIONAL CORP. ALL RIGHTS RESERVED. / ANALYSIS OF DIA RING DEFINITION This includes communicating the implications of that information, How and who do you communicate with. Consider: - Gap analysis (what data is available, what is missing) - Conducting Regulatory surveys (asking a serious of regulatory implication questions) - Business functions such as marketing, quality, supply chain 9

CONFIDENTIAL ©2014 PAREXEL INTERNATIONAL CORP. ALL RIGHTS RESERVED. / ANALYSIS OF DIA RING DEFINITION The act of gathering and analyzing publicly available regulatory information. This includes communicating the implications of that information, and monitoring the current regulatory environment for opportunities to shape future regulations, guidance, policy, and legislation.’ 10

CONFIDENTIAL ©2014 PAREXEL INTERNATIONAL CORP. ALL RIGHTS RESERVED. / ANALYSIS OF DIA RING DEFINITION monitoring the current regulatory environment for opportunities to shape future regulations, guidance, policy, and legislation.’ How can you achieve this: Accomplished with first part of definition (…gathering and analyzing publicly available regulatory information…) Access to Regulatory Authorities public consultation Challenge current guidelines, have a better course of action with justification; communicate with RA Keep abreast of new regulations and the impact they can have on existing directives. 11

CONFIDENTIAL ©2014 PAREXEL INTERNATIONAL CORP. ALL RIGHTS RESERVED. / ANALYSIS OF EU RING DEFINITION THE NEXT SLIDES WILL DISCUSS THE DEFINITION IN FRAGMENTS. 12

CONFIDENTIAL ©2014 PAREXEL INTERNATIONAL CORP. ALL RIGHTS RESERVED. / ANALYSIS OF EU RING DEFINITION Regulatory intelligence is the act of processing targeted information and data from multiple sources, analyzing 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. 13

CONFIDENTIAL ©2014 PAREXEL INTERNATIONAL CORP. ALL RIGHTS RESERVED. / ANALYSIS OF EU RING DEFINITION Regulatory intelligence is the act of processing targeted information and data from multiple sources, More specific than first leg DIA RING (…gathering and analyzing publicly available regulatory information…) Targeted information & data: Seeking specific information for the purpose of your RI, e.g. variation to change the formulation of a drug product that are licenced only in the Asia Pacific (APAC) markets. 14

CONFIDENTIAL ©2014 PAREXEL INTERNATIONAL CORP. ALL RIGHTS RESERVED. / ANALYSIS OF EU RING DEFINITION Regulatory intelligence is the act of processing targeted information and data from multiple sources, Data from multiple sources: - Regulatory Authority websites (e.g. EMA, FDA, TGA and NCA) - Regulatory Journals/Newsletters - Conferences/meetings - Consultants/colleagues - Groups on LinkedIn - Executing a gap analysis (what data is available, what is missing) - Conducting Regulatory surveys (asking a serious of regulatory implication questions) 15

CONFIDENTIAL ©2014 PAREXEL INTERNATIONAL CORP. ALL RIGHTS RESERVED. / ANALYSIS OF EU RING DEFINITION Regulatory intelligence is the act of processing targeted information and data from multiple sources, analyzing 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. 16

CONFIDENTIAL ©2014 PAREXEL INTERNATIONAL CORP. ALL RIGHTS RESERVED. / ANALYSIS OF EU RING DEFINITION analyzing the data in its relevant context and generating a meaningful output – e.g. outlining risks and opportunities – to the regulatory strategy. For example, data for changing the formulation of your drug product. How can the data be analysed to prepare a regulatory strategy & risk analysis to make this change. Consider: - Markets impacted - Type of regulatory change - What documentation are required for submission package - Timeframe for approval - When can the change be implemented - Commercial, Quality and Supply Chain impact 17

CONFIDENTIAL ©2014 PAREXEL INTERNATIONAL CORP. ALL RIGHTS RESERVED. / ANALYSIS OF EU RING DEFINITION Regulatory intelligence is the act of processing targeted information and data from multiple sources, analyzing 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. 18

CONFIDENTIAL ©2014 PAREXEL INTERNATIONAL CORP. ALL RIGHTS RESERVED. / ANALYSIS OF EU RING DEFINITION The process is driven by business needs and linked to decisions and actions. Taking the previous example, changing the formulation of a drug product. What are the possible business needs to drive the RI process? - Improve quality of drug - Reduce cost - Increase productivity 19

CONFIDENTIAL ©2014 PAREXEL INTERNATIONAL CORP. ALL RIGHTS RESERVED. / SUMMARY However you interpret these definitions, RI key aspect is applying the acquired knowledge from drug discovery to post approval. A vast amount of years and cost is invested in getting the drug on the market. Then when it gets to the market, what happens next? This is when the importance of RI ensures the best regulatory strategy so that your drug’s safety, quality and efficacy is maintained during its lifecycle. 20

CONFIDENTIAL ©2014 PAREXEL INTERNATIONAL CORP. ALL RIGHTS RESERVED. / SUMMARY RI PROCESS Regulatory Intelligence Data Collection Data Analysis Risk assessment Regulatory Strategy Communication Application 21

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CONFIDENTIAL ©2014 PAREXEL INTERNATIONAL CORP. ALL RIGHTS RESERVED. / THANK YOU CONFIDENTIAL ©2014 PAREXEL INTERNATIONAL CORP. ALL RIGHTS RESERVED. / 23