THE PRACTICE OF
REGULATORY
INTELLIGENCE:
CASE STUDIES
OMICS 5th International Pharmaceutical
Regulatory Affairs 3 - 5 August 2015, Orlando,
Florida, USA
Presented by: Mariam Aslam
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AGENDA
• Introduction
• Case Study 1
• Case Study 2
• Case Study 3
• Summary
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INTRODUCTION
• Regulatory Intelligence (RI) process
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INTRODUCTION
• Regulatory Affairs Professionals will either execute all or specific steps of
the RI process depending on their role & responsibility
• The following case studies will be illustrated to demonstrate the
importance of gathering RI and how the process steps are delivered:
1. Company A updating their pack design and identified that SPCs need
to be updated to align to current guidelines
2. Company B changing manufacturer of drug product, manufacturing
method and also reformulating the excipients. The current manufacturer
cannot meet Company B’s current demand
3. Company C changing the legal entity name of manufacturing sites on
a global scale
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CASE STUDY 1
Company A updating their pack design and identified that SPCs need
to be updated to align to current guidelines
• Case study 1 will demonstrate where only the following RI segments
were executed:
Data Collection
Data Analysis
Regulatory Strategy
Communication
Application
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CASE STUDY 1 – DATA COLLECTION
Company A updating their pack design and identified that SPCs need
to be updated to align to current guidelines
• Sources of Date Collection:
- Company marketing function
- Product History
- MHRA, EU websites, current regulations and guidelines
- MHRA assessors
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CASE STUDY 1 – DATA ANALYSIS
Company A updating their pack design and identified that SPCs need
to be updated to align to current guidelines
• Data Analysis:
- Data collection from sources
- Current and proposed pack design comparison
- Impact on SPC
- How many products will need a pack design and amended SPC
- PIL required for many existing products
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CASE STUDY 1 – REGULATORY STRATEGY
Company A updating their pack design and identified that SPCs need
to be updated to align to current guidelines
• Regulatory Strategy based on:
- Data collection and analysis
- Business priority needs
- Conditions to be fulfilled for SPC regulatory submission approval
- Procedure type for update to artwork design
- Documentation & fees required for submission package
- Timelines for preparing submission package, approval, grace periods &
new pack design launch
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CASE STUDY 1 – COMMUNICATION
Company A updating their pack design and identified that SPCs need
to be updated to align to current guidelines
• Communicated regulatory strategy with:
- Senior management for green light
- Marketing
- Supply Chain
- Artwork Coordinators/designers
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CASE STUDY 1 – APPLICATION
Company A updating their pack design and identified that SPCs need
to be updated to align to current guidelines
• Steps for Application:
- Preparation of proposed artwork, SPCs
- Internal review and approval of proposed regulatory documentation
- Preparation of submission package
- Submission to Regulatory Authority (MHRA)
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CASE STUDY 1 – CONCLUSION
Company A updating their pack design and identified that SPCs need
to be updated to align to current guidelines
• The updated pack designs and SPCs were approved after a delay of 3
months. This was due to MHRA questions and non acceptance of the
initial proposal during the assessment of the submission package.
• Risks such as the non acceptance of the pack design could have been
controlled by having a preliminary dialogue with the MHRA.
• The execution of a risk assessment to highlight the risks and control of
them would have most likely reduced the approval timeline.
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CASE STUDY 2
Company B changing manufacturer of drug product, manufacturing
method and also reformulating the excipients. The current
manufacturer cannot meet Company B’s current demand
• Case study 2 will demonstrate where all RI segments were executed:
Data Collection
Data Analysis
Risk Assessment
Regulatory Strategy
Communication
Application
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CASE STUDY 2 – DATA COLLECTION
Company B are changing manufacturer of drug product,
manufacturing method and also reformulating the excipients. The
current manufacturer cannot meet Company B’s current demand
• Sources of date collection:
- Company marketing, supply chain and quality function
- Product History
- MHRA, EU websites, current regulations and guidelines
- MHRA assessors
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CASE STUDY 2 – DATA ANALYSIS
Company B changing manufacturer of drug product, manufacturing
method and also reformulating the excipients. The current
manufacturer cannot meet Company B’s current demand
• Data Analysis:
- Data collection from sources
- Impact on SPC and packaging
- Availability of documentation required for submission package such valid
GMP Certificate, QP declaration, stability studies
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CASE STUDY 2 – RISK ASSESSMENT
Company B changing manufacturer of drug product, manufacturing
method and also reformulating the excipients. The current
manufacturer cannot meet Company B’s current demand
• Risk Assessment:
- Incomplete submission, such as insufficient data
- Incorrect variation procedure type and change code resulting in nonacceptance
- Grouping of variations submitted to the MHRA has not been preapproved
- Pre-approval notification of grouping of variations has not been included
in the submission package
- Disruption in supply of drug due to current manufacturer no longer
meeting company’s current demand
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CASE STUDY 2 – REGULATORY STRATEGY
Company B changing manufacturer of drug product, manufacturing
method and also reformulating the excipients. The current
manufacturer cannot meet Company B’s current demand
• Regulatory Strategy based on:
- Data collection and analysis including submission procedure type
- Business priority needs
- Conditions to be fulfilled for regulatory submission approval
- Documentation & fees required for submission package
- Timelines for preparing submission package, approval, grace periods
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CASE STUDY 2 – COMMUNICATION
Company B changing manufacturer of drug product, manufacturing
method and also reformulating the excipients. The current
manufacturer cannot meet Company B’s current demand
• Communication with:
• MHRA for pre-submission dialogue
- Senior management, Quality, Manufacturing, Supply Chain and
Marketing for green light
- Artwork Coordinators/designers
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CASE STUDY 2 – APPLICATION
Company B changing manufacturer of drug product, manufacturing
method and also reformulating the excipients. The current
manufacturer cannot meet Company B’s current demand
• Steps for Application:
- Preparation of proposed artwork, SPCs
- Internal review and approval of proposed regulatory documentation
- Preparation of submission package
- Submission to Regulatory Authority (MHRA)
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CASE STUDY 2 – CONCLUSION
Company B changing manufacturer of drug product, manufacturing
method and also reformulating the excipients. The current
manufacturer cannot meet Company B’s current demand
Although the submission package had a long than anticipated approval
timeline, the pre-submission dialogue/communication and control of risks
ensured continuation of drug supply.
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CASE STUDY 3
Company C changing the legal entity name of manufacturing sites on
a global scale
• Case study 3 demonstrates where the following RI segments were
executed:
Data Collection & Data Analysis:
- Executing a gap analysis (what data is available, what is missing)
- Conducting Regulatory surveys (asking a serious of regulatory
implication questions) in all impacted countries
Conclusion:
Due to the complexity of this change, executing the above RI steps is
imperative prior to proceeding to the steps of the RI process.
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SUMMARY
• RI should be executed at an early stage to identify and manage risks.
• Regulatory strategy is driven by the implementation of RI.
• These case studies demonstrate that RI is an important task to execute
when a company is making changes to it medicines and at the same
time ensuring the continuation of supply.
• One final point - I was practicing RI on a daily basis about ten years ago
in my first RA role. To conclude, Regulatory Intelligence (RI) has always
been an industry practice. It is gradually being acknowledged in its own
right and gaining it’s long awaited recognition.
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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
Mariam.Aslam@PAREXEL.com
www.PAREXEL.com
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THANK YOU
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