All posts by admin

Combination Products – Basic Principles: Regulatory Framework, Current Issues and Status

  • Background: combination products, how they work, how are they used; history, development analysis of relevant FDA laws, regulations, guidance, policy, organization; contrast to EU approach
  • Drug delivery systems, medicated devices, companion diagnostics, drug/biologic combination products
  • Product development: preclinical, clinical, CMC/device; collaborative development; strategy
  • Marketing applications and labeling: format and content; CTD
  • Quality Systems
  • Safety Reporting
  • Post-approval change reporting
  • Compendial requirements
  • Other pre- and post-approval issues
  • Case studies

Combination Products – Advanced: Strategic Thinking to Solve Combination Product Problems

  • Product development: preclinical, clinical, CMC/device; collaborative development; strategy
  • Impact of marketing application and labeling structure
  • Advertising and promotion
  • Designing and establishing quality systems
  • Device design controls, design validation, human factors
  • Designing and establishing safety reporting systems
  • Compliance and inspections
  • Other pre- and post-approval issues
  • Combination product problem analysis
  • Case studies

Technical Development and Regulation of Drug (and Biologic) Delivery Devices and Systems

  • Background: anatomy, technical requirements, standards compendial and regulatory requirements for prefilled syringes and single-use disposable, reusable, general use and specific use drug delivery systems (viz., injection-, pulmonary-, nasal- and transdermal-based; safety devices and other drug delivery devices and accessories); how they work, how are they used, how they are regulated
  • History, development and analysis of relevant FDA laws, regulations, guidance, policy, organization for drug delivery devices and systems’ contrast to EU approach
  • Product development: preclinical, clinical, CMC/device; collaborative development; strategy for drug delivery devices and systems
  • Device design controls, design validation, human factors
  • Marketing applications and labeling: format and content for drug delivery devices and systems; CTD
  • Quality Systems for drug delivery devices and systems
  • Safety Reporting for drug delivery devices and systems
  • Post-approval change reporting for drug delivery devices and systems
  • Other pre- and post-approval issues for drug delivery devices and systems
  • Case studies

Designing and Establishing a Quality System for the Development and Manufacture of a Drug (and Biologic) Delivery System

  • Background: anatomy, technical requirements, standards, compendial, regulatory requirements for prefilled syringes and single-use disposable, reusable, general use and specific use drug delivery systems (viz., injection-, pulmonary-, nasal- and transdermal-based; safety devices, other drug delivery devices and accessories); how they work, how are they used, how they are regulated
  • Evolution and current state of quality system regulatory requirements pertaining to drug delivery devices and drug delivery systems; applicability
  • CGMP, QSR, GTP and other quality related FDA regulations
  • Device design controls, design validation, human factors
  • Applicable quality related standards
  • Collaborative development paradigms for drug delivery devices and systems, development and purchasing relationships, requirements, vendor controls
  • Streamlined, linked, isolated quality systems
  • Compliance and inspections

Designing and Establishing a Quality System for the Development and Manufacture of a Medicated Device

  • Background: anatomy, technical requirements, standards, compendial and regulatory requirements for a variety of medicated devices (viz., drug-coated stents, -catheters, -implants, -electrode leads) and systems; how they work, how are they used how they are regulated
  • Evolution and current state of quality system regulatory requirements pertaining to medicated devices and systems; applicability
  • CGMP, QSR, GTP, and other quality related FDA regulations
  • Device design controls, design validation, human factors
  • Applicable quality related standards
  • Collaborative development of drug delivery devices and systems, development and purchasing relationships, requirements and vendor controls
  • Streamlined, linked and isolated quality systems
  • Compliance and inspections

Designing and Establishing a Quality System for the Development and Manufacture of Cellular Therapy and Tissue Based Combination Products

  • Background: technical requirements, standards, compendial and regulatory requirements for cellular and tissue-based combination products
  • Evolution and current state of quality regulations pertaining to cellular and tissue based combination products; applicability
  • CGMP, QSR, GTP, and other quality related FDA regulations
  • Device design controls, design validation, human factors
  • Applicable quality related standards
  • Collaborative development of cellular and tissue-based combination products, development and purchasing relationships, requirements, vendor controls
  • Streamlined, linked and isolated quality systems
  • Compliance and inspections

Quality Auditing of Drug Delivery Device Constituent Part and Component Part Manufactures

  • Preparatory training for QSR compliance audits of drug delivery device component and constituent part co-development partners, manufacturers, vendors and/or contractors
  • Background: anatomy, technical requirements, standards compendial, regulatory requirements for prefilled syringes and single-use disposable, reusable, general use and specific use drug delivery systems (viz., injection-, pulmonary-, nasal- and transdermal-based; safety devices and other drug delivery devices and accessories); how they work, how are they used, how they are regulated
  • Evolution and current state of quality system regulatory requirements pertaining to drug delivery devices and drug delivery systems; applicability
  • Key QSR requirements: Management Responsibility; Purchasing Controls, Change Controls, Design Controls, CAPA
  • ICH guidelines
  • Collaborative development paradigms for drug delivery devices and systems
  • Sponsor and vendor relationships and responsibilities; development and purchasing relationships, requirements, vendor controls
  • Drug and Device Master Files
  • Compliance and Inspections
  • Audits

Quality Auditing of Medicated Device Constituent Part and Component Part Manufactures

  • Preparatory training for CGMP compliance audits of medicated device component and constituent part co-development partners, manufacturers, vendors and/or, contractors
  • Background: anatomy, technical requirements, standards, compendial and regulatory requirements for a variety of medicated devices (viz., drug-coated stents, -catheters, -implants, -electrode leads) and systems; how they work, how are they used and how they are regulated
  • Evolution and current state of quality system regulatory requirements pertaining to medicated devices and systems; applicability
  • Key CGMP requirements: calculation of yield, stability studies and expiration dating, drug substance testing and release for distribution, reserve samples
  • ICH guidelines
  • Collaborative development paradigm for medicated devices and systems
  • Sponsor and vendor relationships and responsibilities; development and purchasing relationships, requirements and vendor controls
  • Drug Master Files and Device Master Files
  • Compliance and Inspections
  • Audits

Combination Products: US, EU, and Japan Regulations

  • How combination/borderline products are regulated in the US, EU and Japan.
  • How to interpret and comply with current US, EU and Japan regulatory requirements for combination/borderline products (i.e., GMPs, reporting post-approval changes and safety reports); what regulations, directives, guidance and standards do and do not exist, or apply; how to manage gaps in the regulatory frameworks.
  • Format, content and submission of marketing applications submitted in the US, EU and Japan for combination/borderline products.
  • CE marking of devices that are part of a combination/borderline product and devices containing ancillary medicinal substances.
  • Quality System requirements for combination/borderline products in the US, EU and Japan and how these apply to pharmaceutical and medical device companies, constituent part and component part manufacturers.