Investigational Products (Invest Prod) refers to a preventative (vaccine), a therapeutic (drug or biologic) device, diagnostic, or palliative used in a clinical trial. An investigational product may be an unlicensed or licensed product when used or assembled (formulated or packaged) differently from the approved form, when used for an unapproved indication, or when used to gain further information about an approved use.
PE Articles
Use of Booklet Labels on Investigational Medicinal Products (IMPs)
The objective of this concept paper is to reflect on a study site survey performed, to draw…
PE Articles
The Application of GAMP® 5 to the Implementation and Operation of a GxP Compliant Clinical System
The need to validate computerized systems used in the context of a clinical trial has increasingly…
PE Articles
Validation & Data Integrity in eClinical Platforms
To address the trial specific setups, eClinical solutions have to be built from various integrated…
iSpeak Blog
Empowering Novel Therapies: Automation Best Practices for cGMP Processes
Novel therapies refer to innovative and often groundbreaking approaches to treating medical…
PE Articles
Investigator Initiated Trials (IIT) – Considerations and Guidance from the Perspective of Clinical Trial Supplies and GMP
This Concept Paper is designed to give a better understanding of the challenges and requirements…
Product
Comprehensive Guide to Clinical Materials
The Guide is designed to provide a valuable tool for the development of in-house training sessions…
Product
Good Practice Guide: Comparator Management
Published: February 2012 Pages: 84 Table of Contents Special Pricing for Emerging Economies The ISPE…
Product
Good Practice Guide: Development of Investigational Therapeutic Biological Products
Published: August 2007 Pages: 92 Table of Contents Special Pricing for Emerging Economies With the…
PE Articles
Introducing CoP Leader Profiles: Rachel Owen
With this issue, Pharmaceutical Engineering ® launches a new feature in P+E: profiles of Communities…
PE Articles
A New Regulatory Approach to Drive Sustainable Medicines
To enable changes across the pharmaceutical industry, sustainability should be included alongside…
iSpeak Blog
Reverse Logistics Planning Can Save Time, Money, and Effort
Does your company only focus on how to get the product to patient without considering what happens…
Product
Good Practice Guide: IMP Reverse Logistics
Every year the number of clinical trials conducted across the globe rises in a concerted effort to…
Guidance Documents
Biotechnology (1)
Investigational Products (8)
- Comprehensive Guide to Clinical Materials
- Good Practice Guide: Comparator Management
- Good Practice Guide: Development of Investigational Therapeutic Biological Products
- Good Practice Guide: IMP Reverse Logistics
- Good Practice Guide: Harmonizing the Definition and Use of NIMPs
- Good Practice Guide: Clinical Supply Systems
- Good Practice Guide: Interactive Response Technology
- Introductory US Clinical Trial Materials Training Guide
Supply Chain Management (1)
Pharmaceutical Engineering Magazine Articles
Introducing CoP Leader Profiles: Rachel Owen
With this issue, Pharmaceutical Engineering ® launches a new feature in P+E: profiles of Communities…
A New Regulatory Approach to Drive Sustainable Medicines
To enable changes across the pharmaceutical industry, sustainability should be included alongside…
Model-Informed Drug Development Addresses COVID-19 Challenges
Drug developers know that the odds of anyone compound demonstrating safety and efficacy for a…
White Papers
November / December 2024
Plastic Process Waste in Biopharmaceutical Manufacturing Cover: This article presents a…
September / October 2024
PIC/S in Latin America: Harmonization of cGMP Procedures Cover: This article offers an overview of…
July / August 2024
The explosive growth of advanced therapy medicinal products (ATMPs), particularly cellular…
Pharmaceutical Job Board
iSpeak Blog Posts
Professional Development Training
ICH Q10: Pharmaceutical Quality System (PQS)
The Pharmaceutical Quality System (PQS), as defined by ICH Q10, ensures product quality and continuous improvement throughout the lifecycle of pharmaceutical products. Overview This fundamental online course introduces the Pharmaceutical Quality System (PQS), which is a framework that ensures product quality meets established standards throughout the lifecycle of pharmaceutical products. It aims for suitable process performance by implementing robust controls for drug development and manufacturing, including quality assurance, risk management, and regulatory compliance. The system identifies…
A GAMP® Guide to Computerized Systems Compliance
Fundamental Principles of Compliance for Computerized Systems: Implementing the GAMP® 5 Guide This fundamental online course introduces participants to regulatory requirements for computerized systems in the pharmaceutical industry and explores tried, tested, and internationally recognized methods of meeting those requirements. GAMP ® guidance provides a pragmatic and effective framework for achieving computerized systems that are fit for intended use and meet current regulatory requirements, by building upon existing industry good practice in an efficient and effective manner. Course Modules…
ICH Q9(R1): Guidelines on Pharmaceutical Risk Management
Delivery Mode: Webinar An introduction to the ICH Q9(R1): Guidelines on Pharmaceutical Risk Management. This lesson covers the fundamentals for assessing and mitigating risks during drug product lifecycles and incorporates the latest requirements from ICH Q9(R1), which was updated in 2023, and supports and sets the foundation for a safety and quality-centric approach. By integrating with other ICH standards, it sets the foundation for a safety and quality-centric approach. CEUs are provided once you achieve an 80% passing grade and complete the evaluation. The course is self-paced. On average…
ICH Q6A: Specifications, Test Procedures, and Acceptance Criteria for New Drug Substances and Products
Delivery Mode: Webinar This course covers testing and quality control requirements in marketing authorization/new drug applications, emphasizing ICH guidelines. It focuses on ICH Q6A, detailing test procedures and acceptance criteria for new drug substances/products to ensure global consistency and safety. The course also integrates later guidelines (ICH Q8, Q9, Q10, Q11), introducing science and risk-based approaches. Participants will learn to navigate global marketing authorization/new drug applications, contributing to high-quality pharmaceutical product development. CEUs are provided once…
GxPs for Leadership
This comprehensive course will equip you with the knowledge and skills to ensure GxP compliance and inspection readiness in the pharmaceutical industry. You will thoroughly understand regulatory requirements and learn about management's role in maintaining safety and quality. The course covers essential topics such as regulatory expectations, responsibilities in compliance, and consequences of non-compliance.
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