About Cabling Installation & Maintenance

Our mission: Bringing practical business and technical intelligence to today's structured cabling professionals

For more than 30 years, Cabling Installation & Maintenance has provided useful, practical information to professionals responsible for the specification, design, installation and management of structured cabling systems serving enterprise, data center and other environments. These professionals are challenged to stay informed of constantly evolving standards, system-design and installation approaches, product and system capabilities, technologies, as well as applications that rely on high-performance structured cabling systems. Our editors synthesize these complex issues into multiple information products. This portfolio of information products provides concrete detail that improves the efficiency of day-to-day operations, and equips cabling professionals with the perspective that enables strategic planning for networks’ optimum long-term performance.

Throughout our annual magazine, weekly email newsletters and 24/7/365 website, Cabling Installation & Maintenance digs into the essential topics our audience focuses on.

  • Design, Installation and Testing: We explain the bottom-up design of cabling systems, from case histories of actual projects to solutions for specific problems or aspects of the design process. We also look at specific installations using a case-history approach to highlight challenging problems, solutions and unique features. Additionally, we examine evolving test-and-measurement technologies and techniques designed to address the standards-governed and practical-use performance requirements of cabling systems.
  • Technology: We evaluate product innovations and technology trends as they impact a particular product class through interviews with manufacturers, installers and users, as well as contributed articles from subject-matter experts.
  • Data Center: Cabling Installation & Maintenance takes an in-depth look at design and installation workmanship issues as well as the unique technology being deployed specifically for data centers.
  • Physical Security: Focusing on the areas in which security and IT—and the infrastructure for both—interlock and overlap, we pay specific attention to Internet Protocol’s influence over the development of security applications.
  • Standards: Tracking the activities of North American and international standards-making organizations, we provide updates on specifications that are in-progress, looking forward to how they will affect cabling-system design and installation. We also produce articles explaining the practical aspects of designing and installing cabling systems in accordance with the specifications of established standards.

Cabling Installation & Maintenance is published by Endeavor Business Media, a division of EndeavorB2B.

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Patrick McLaughlin

Serena Aburahma

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2 Day FDA (Food and Drug Administration) Drug Approval Process Training Course | Stay Ahead with Insights into IND, NDA, ANDA, and 505(b)(2) Submissions (ONLINE EVENT: October 7-8, 2025) - ResearchAndMarkets.com

The "The FDA (Food and Drug Administration) Drug Approval Process Training Course" training has been added to ResearchAndMarkets.com's offering.

The US is the largest market globally for pharmaceutical sales, so having a good understanding of FDA procedures is vital for those submitting in this challenging region. This course will help clarify the US regulatory process, giving you a practical insight into FDA requirements and ensuring that you are fully up to date with all the latest developments.

The comprehensive programme will cover procedures for submission of INDs, NDAs, ANDAs and 505(b)(2), provide a useful insight into the organisation and structure of the FDA and its review processes, and highlight recent changes. The course will emphasise areas of interest to innovative manufacturers, but will also deal with issues relating to generic and over-the-counter drugs.

There will be ample opportunity for discussion with our expert trainer as well as other delegates and a practical workshop session to optimise learning.

Benefits of attending:

  • Review the latest FDA regulatory requirements for drug development
  • Understand FDA regulatory strategic needs
  • Ensure that you comply with FDA requirements for NDAs, ANDAs and 505(b)(2)
  • Discuss recent changes and developments with an industry expert and Improve your communication and interactions with the FDA

Certifications:

  • CPD: 12 hours for your records
  • Certificate of completion 

Who Should Attend:

This programme will be especially beneficial to those responsible for preparing US registration documents (INDs, NDAs, Biologics License Applications, etc), regulatory affairs personnel, lawyers and others responsible for advising companies on strategies for developing new drugs for the US market.

Key Topics Covered:

Day 1

Pharmaceutical Medicine and Documents

  • The role of regulatory affairs
  • The purpose of the Common Technical Document (CTD)

FDA History and Organisation

  • Review of FDA centers
  • Organization of the CDER and CBER
  • Differences between CDER and CBER

Legal Basis (Patent Exclusivity PDUFA, GDUFA, BsUFA)

  • 21st century cure act
  • Patent and exclusivity
  • PDUFA
  • GDUFA
  • BsUFA

Legal Basis Continued

Application and Submissions Types

  • Investigational new drugs (IND)
  • New drug applications (NDA)
  • Abbreviated new drug applications (ANDA)
  • Over the counter drugs (OTC)
  • Biologics license applications (BLA)
  • Orphan drug designations

Refusal to File

  • Reasons for refusal
  • The regulatory process

Investigational New Drug (IND) Applications

  • Review of the content of an IND

Getting Products to the Market Faster

  • Review of expedited programs in the US
    • Fast Track designation
    • Breakthrough Therapy designation
    • Accelerated Approval
    • Priority Review designation

FDA Meetings and Documentation

  • FDA communication philosophy
  • Different meeting types
    • Scope
    • Format
    • Procedure

CTD Content - Setting the Scene

  • Lean authoring to ensure possible document re-use for multiple purposes
  • A review of the different modules

CTD Content - M1

Day 2

CTD Content - M3 and Corresponding M2

CTD Content - M4 and Corresponding M2

CTD Content - M5 and Corresponding M2

Submission Format and Methods

  • Study tagging files
  • Datasets
    • Case report forms
    • Bioresearch monitoring (BIMO) clinical data

US Amendment Procedures

  • A review of US amendment procedures (incl. annual reports, minor/major changes)

High Level Comparison US vs EU

  • A review of the main differences in terms of dossier content and procedures

Case Study

For more information about this training visit https://www.researchandmarkets.com/r/mzbvbf

About ResearchAndMarkets.com

ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

Contacts

ResearchAndMarkets.com

Laura Wood, Senior Press Manager

press@researchandmarkets.com



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