Regulatory Intelligence
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Regulatory intelligence plays an important role in the pharmaceutical industry by helping companies stay compliant, influence regulations, and make strategic decisions. Key responsibilities of regulatory intelligence functions are to identify regulatory changes, conduct analyses to facilitate decision making, and serve as internal consultants. Having access to sources like regulatory authorities and trade associations helps with identifying opportunities, reducing costs and time to market, and increasing compliance. However, challenges include the large volume of information, regional differences, and unclear agency expectations that require regulatory professionals to "read between the lines".
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Regulatory Intelligence
Regulatory intelligence involves acquiring knowledge through analyzing various internal and external information sources to enable timely, data-driven decision making in the complex and evolving global regulatory landscape. A regulatory intelligence platform can integrate internal quality and compliance data with external sources like FDA reports, clinical studies, and regulations. This provides a holistic view to identify risks, prioritize improvements, and help maintain market advantage. However, many organizations still struggle with data access, analysis, and using analytics to impact business outcomes. Assessing internal audit and complaint data alongside external benchmarks can help evaluate inspection readiness and prioritize compliance issues.
Regulatory intelligence
The document discusses regulatory intelligence and its importance. It defines regulatory intelligence as gathering and analyzing publicly available regulatory information, communicating implications, and monitoring regulations for opportunities. Sources of information discussed include regulatory authority websites, agency meeting minutes, previous drug approvals, and social media. Regulatory intelligence is used by pharmaceutical companies for product planning, regulatory agencies to consider precedents, and lawyers to interpret laws. The document encourages sharing knowledge and regulatory intelligence methods.
Regulatory Intelligence (Mis)Management in the Medical Device Industry: How t...
Let’s face it - regulatory affairs is a critical business function for regulated industries that is a misunderstood, highly complex, and ever-evolving profession.
Regulatory costs are rising, regulatory burdens are increasing, global regulatory matters are becoming more complex, and qualified candidates are scarce.
The mismanagement of information can cost your company time, money and resources.
Specifically, you will learn:
-True Regulatory Intelligence Management (RIM) – What is -Regulatory Intelligence Management and how should it be properly utilized?
-Regulatory Affairs Profession – How has regulatory affairs changed over the course of the last ten years and where is the profession headed?
-The Sales and Regulatory Love/Hate Relationship – Why do your sales and regulatory teams need to get on the same page?
-Building a Business Case to New Market Entry - How can this simple strategy save your company a lot of heartburn?
-How to Manage It All – What is the importance of information and intelligence management and how can innovative software (i.e. RIMSYS Regulatory Software) save your business time, money and embarrassment?
Watch the presentation here: https://www.greenlight.guru/webinar/regulatory-intelligence-mismanagement
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Regulatory Intelligence
Regulatory intelligence involves acquiring knowledge through analyzing various internal and external information sources to enable timely, data-driven decision making in the complex and evolving global regulatory landscape. A regulatory intelligence platform can integrate internal quality and compliance data with external sources like FDA reports, clinical studies, and regulations. This provides a holistic view to identify risks, prioritize improvements, and help maintain market advantage. However, many organizations still struggle with data access, analysis, and using analytics to impact business outcomes. Assessing internal audit and complaint data alongside external benchmarks can help evaluate inspection readiness and prioritize compliance issues.
Regulatory intelligence
The document discusses regulatory intelligence and its importance. It defines regulatory intelligence as gathering and analyzing publicly available regulatory information, communicating implications, and monitoring regulations for opportunities. Sources of information discussed include regulatory authority websites, agency meeting minutes, previous drug approvals, and social media. Regulatory intelligence is used by pharmaceutical companies for product planning, regulatory agencies to consider precedents, and lawyers to interpret laws. The document encourages sharing knowledge and regulatory intelligence methods.
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Regulatory costs are rising, regulatory burdens are increasing, global regulatory matters are becoming more complex, and qualified candidates are scarce.
The mismanagement of information can cost your company time, money and resources.
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-True Regulatory Intelligence Management (RIM) – What is -Regulatory Intelligence Management and how should it be properly utilized?
-Regulatory Affairs Profession – How has regulatory affairs changed over the course of the last ten years and where is the profession headed?
-The Sales and Regulatory Love/Hate Relationship – Why do your sales and regulatory teams need to get on the same page?
-Building a Business Case to New Market Entry - How can this simple strategy save your company a lot of heartburn?
-How to Manage It All – What is the importance of information and intelligence management and how can innovative software (i.e. RIMSYS Regulatory Software) save your business time, money and embarrassment?
Watch the presentation here: https://www.greenlight.guru/webinar/regulatory-intelligence-mismanagement
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Type 1A and 1B variations are minor variations that have minimal or no impact on safety, efficacy, or quality. Type 1A variations are further divided into those requiring immediate notification ("IAIN") and those not requiring it ("IA"). Type II variations are major variations that may significantly impact safety, efficacy, or quality. Extensions apply to changes like new strengths or forms and require full evaluation. Variations are submitted based on classification and some can be grouped together in a single submission. The process involves regulatory submission and approval timelines that differ based on variation type. Marketing authorizations must be renewed every 5 years upon application by the holder to remain valid indefinitely.
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As serialization and track-and-trace capabilities go mainstream to meet regulatory compliance mandates, pharmaceuticals companies should simultaneously explore how these tools and techniques can improve supply chain planning and operations, elevate patient and doctor engagement, and increase sales and marketing effectiveness.
Serialization: Driving Business Value Beyond Compliance
Serialization and track-and-trace capabilities are not just useful for meeting regulatory compliance mandates; pharmaceutical companies can also explore their use to improve supply chain planning and operations, elevate patient engagement, and increase sales and marketing effectiveness.
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This document provides information about the "5th Annual Global Transparency Reporting Congress" conference that will take place on April 15-16, 2015 in London. The conference will focus on evolving guidelines for disclosing healthcare professional spending across the globe. It will include sessions on best practices for implementing transparency codes and managing relationships with healthcare professionals. Representatives from EFPIA, ABPI, various pharmaceutical companies, and medical organizations are scheduled to present.
Global Pharma report 2014
This document provides a summary of a report on global traceability and serialization in the pharmaceutical industry. It discusses the results of a survey on pharmaceutical serialization and traceability in 2014. The main challenges for manufacturers in implementing serialization included cost, integration with existing systems, generating high-speed printing of unique codes, and inconsistent regulations across countries. Regulations like the EU Falsified Medicines Directive and the US Drug Supply Chain Security Act are aiming to improve security and tracking of pharmaceuticals in the supply chain. Overall, the report examines the progress of serialization efforts and the ongoing challenges faced by the industry.
Drug Quality and Security Act
The Drug Quality and Security Act grants the FDA more authority to regulate compounded drugs in response to a 2012 meningitis outbreak. The Act requires serialization of drug products, with serial numbers encoded in 2D barcodes by certain deadlines. This increases tracking of drugs throughout the supply chain. SAP Advanced Track and Trace for Pharmaceuticals provides a single platform to manage serial numbers, integrate serialization into business processes, simplify regulatory reporting to different countries, and scale to handle increasing serialization data volumes.
How is digital innovation affecting the pharmaceutical industry- Presentation
This document provides recommendations for digital innovations that can help pharmaceutical companies address business priorities related to risk and compliance management and research and development enhancement. It outlines two main business priorities, breaks them down into sub-segments, and then recommends potential solutions in the form of software and startups. The solutions are categorized by their level of maturity from emerging to scaling to mature. The document aims to help decision makers in the pharmaceutical industry navigate the changing technology landscape and make more informed choices.
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Regulatory Intelligence
- 1. REGULATORY INTELLIGENCE – Role In Pharmaceutical Industry BY SHRUTI KARGUTKAR
- 2. INTRODUCTION “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.
- 3. Why Regulatory Intelligence? - Pharmaceutical Industry Heavily Regulated - Companies Operating Globally And Need To Be Compliant - Influence Future Regulatory Framework
- 4. Key responsibility of RI function Identify and communicate significant changes in the regulatory environment Conduct and deliver analyses that facilitate strategic decision-making Serve as internal regulatory consultants and respond to adhoc intelligence requests Facilitate access to high-value regulatory intelligence sources Enable effective advocacy work
- 6. Benefits of RI activities Identifying regulatory opportunities Reduced time to market Reduced development costs Increased compliance
- 8. Challenges for RI professional include Ever increasing growth of information Regulatory Authority transparency initiatives Regional differences Information flow
- 9. COMPONENTS OF REGULATORY INTELLIGENCE 1. COMPETITOR INFORMATION 2. REGULATORY ENVIRONMENT 3. LEGAL REQUIREMENTS 4. REGULATORY STRATEGY
- 10. BENEFITS 1. Identifying regulatory opportunities 2. Reduced time to market 3. Reduced development costs 4. Increased compliance
- 11. COMPETITOR INFORMATION Status Of Competitive Drug – 1. Pre-clinical 2. Clinical 3. Launched 4. Where Launched 5. Post-approval Commitments
- 12. Regulatory Environment Agency Benchmarks Regulatory Guidance Documents & Changes Trade Associations Regulatory Associations (ICH & WHO)
- 13. Legal Environment General requirements Specific Populations Orphan drug designation
- 15. “RI PROFESSIONALS OFTEN HAVE TO READ BETWEEN THE LINES, BECAUSE AGENCY’S EXPECTATIONS AND REQUIREMENTS ARE NOT ALWAYS CLEAR” -GARY BUEHLER VP OF GLOBAL REGULATORY INTELLIGENCE TEVA PHARMA
- 16. Going Beyond Traditional Outsourcing Services Even though companies have started opting for regulatory outsourcing partners, the trends in services dynamically change every now and then. The year 2013-2014 witnessed a commendable growth of more than 40% in just the regulatory publishing and writing services out of the entire regulatory outsourcing market. However earlier the main focus persisted the functional tasks such as dossier management and & submissions, now we see new doors unlocked for companies for new regulatory undertakings like Regulatory Intelligence, CMC and labelling and regulatory data management
- 17. REFERENCES 1. Why Regulatory Intelligence Is More Important Than Ever- By Cathy Yarbrough 2. European Industrial Pharmacists Group –Guide to Good Regulatory Practice 3. www.europeanregulatory.com/regulatory- intelligence/ 4. TOPRA 5. “The company regulatory intelligence (RI) function”The Regulatory Affairs Journal-pharma”, October 2007
- 18. Thank You
- 19. Questions?