Transcript Regulatory intelligence: industry`s best practice

REGULATORY
INTELLIGENCE:
INDUSTRY’S BEST
PRACTICE
OMICS 5th International Pharmaceutical
Regulatory Affairs , 3 - 5 August 2015, Orlando,
Florida, USA
Presented by: Mariam Aslam
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AGENDA
• Introduction
• Definition of Regulatory
Intelligence (RI)
• Analysis of Definition
• Summary
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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).
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DEFINITION OF REGULATORY INTELLIGENCE (RI)
THE EU RING DEFINITION
THE DIA 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.'
‘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.’
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ANALYSIS OF DIA
RING DEFINITION
THE NEXT SLIDES
WILL DISCUSS THE
DEFINITION IN
FRAGMENTS.
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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.’
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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)
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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.’
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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
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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.’
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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.
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ANALYSIS OF EU
RING DEFINITION
THE NEXT SLIDES
WILL DISCUSS THE
DEFINITION IN
FRAGMENTS.
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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.
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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.
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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)
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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.
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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
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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.
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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
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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.
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SUMMARY
RI PROCESS
Data
Collection
Application
Data Analysis
Regulatory
Intelligence
Communication
Risk
assessment
Regulatory
Strategy
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CONTACT DETAILS
Mariam Aslam
Senior Consultant
PAREXEL International
101-105 Oxford Road
Uxbridge
Middlesex, UB8 1LZ, United Kingdom
T +44 (0) 1895 818747
M +44 (0) 7918 733437
[email protected]
www.PAREXEL.com
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THANK YOU
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