Pharmaceutical Regulatory Compliance Overview

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Questions and Answers

What is the core business of LexisNexis Reed Tech?

  • Providing training to pharmaceutical companies
  • Managing Unique Device Identification (UDI) product data (correct)
  • Developing software tools for health records
  • Regulatory consulting for medical device manufacturers

When will Health Canada require the use of XML PM submissions for certain types?

  • Beginning January 1, 2026
  • In 2023 only
  • Starting July 18, 2025 (correct)
  • By the end of 2024

Which organization modified the Opioid Analgesic Risk Evaluation and Mitigation Strategy (OA REMS)?

  • National Institutes of Health
  • Center for Disease Control
  • U.S. Food and Drug Administration (correct)
  • World Health Organization

What is one benefit of Unique Device Identification (UDI) regulations?

<p>Enhancing patient safety (B)</p> Signup and view all the answers

What advantage do the software solutions from Reed Tech offer to its clients?

<p>They enable clients to meet UDI compliance dates. (A)</p> Signup and view all the answers

Which type of services does LexisNexis Reed Tech provide specifically for US FDA product listings?

<p>Outsourced Structured Product Labeling Services (SPL) (B)</p> Signup and view all the answers

What issue did Cadwell face that prompted them to seek help from Reed Tech?

<p>Streamlining complex medical device data submission processes (A)</p> Signup and view all the answers

How do Reed Tech’s customers describe their customer service?

<p>Top-notch, friendly, and professional (C)</p> Signup and view all the answers

Flashcards

Unique Device Identification (UDI)

A system that uniquely identifies medical devices throughout their lifecycle. It helps track devices, improve patient safety, and manage recalls.

UDI Regulations

A set of regulations that require medical device manufacturers to label their products with a unique identifier. These regulations aim to improve patient safety, streamline supply chain management, and facilitate efficient recalls.

Medical Device Data Submission

A process by which medical device manufacturers submit product data, including UDI information, to regulatory authorities. This submission process often involves specific formats and standards.

Structured Product Labeling (SPL)

A type of regulatory submission that includes extensive information about a drug product, including its labeling, manufacturing details, and clinical trial results. It is commonly required for drug approval by the US FDA.

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Extensible Markup Language Product Monograph (XML PM)

A digital standard for product labeling information, primarily used by the US FDA. It allows for electronic submission and processing of product labeling data.

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Opioid Analgesic Risk Evaluation and Mitigation Strategy (OA REMS)

A strategy implemented by the US FDA to minimize the risks associated with opioid analgesics. It involves specific requirements aimed at promoting safe and appropriate use of these medications.

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Regulatory Consulting and Outsource Services

A service provided by companies like LexisNexis Reed Tech that helps manufacturers prepare and submit regulatory documentation, including product labeling and UDI data, to health authorities.

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LexisNexis Reed Tech

A company that specializes in providing software solutions and services to help medical device and pharmaceutical companies comply with UDI regulations and other regulatory requirements. They offer tools and expertise to manage product data, generate labels, and submit regulatory documents.

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Study Notes

LexisNexis Reed Tech Services

  • LexisNexis Reed Tech serves pharmaceutical labelers and medical device manufacturers globally, from small to large companies.
  • Their solutions aim to boost productivity, ensure regulatory compliance, and facilitate quicker decision-making.
  • Core business revolves around managing Unique Device Identification (UDI) product data for global health authorities.
  • Offers regulatory consulting, outsourced Structured Product Labeling (SPL) services for US FDA listings, eCTD, US Agent services, and drug/establishment registrations.

Health Canada's XML PM Implementation

  • Health Canada mandates the use of XML product monographs (XML PM) for submissions.
  • Implementation occurs in phases, with the first phase commencing July 18, 2025.
  • Initial phase requires specific submission types to include XML PM upon filing.

FDA's Opioid Analgesic REMS Modification

  • The FDA approved a modified Opioid Analgesic Risk Evaluation and Mitigation Strategy (OA REMS) on October 31, 2024.

UDI Regulations and Benefits

  • Unique Device Identification (UDI) regulations are prioritized by global health authorities.
  • These regulations enhance patient safety, improve supply chain management, and facilitate efficient medical device recalls.

Customer Testimonials

  • Reed Tech is praised for exceptional customer service, technical support, and partnership approach.
  • Customers highlight expertise in Drug Listing and UDI, along with reliable guidance.
  • Customers credit Reed Tech's team with consistently successful SPL generation.

Cadwell's Data Management Needs

  • Cadwell needed to streamline medical device data submissions due to multiple health authorities, regions, and divisions involved.
  • They sought to gain control over dispersed data sources (spreadsheets).

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