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
July / August 2024
The explosive growth of advanced therapy medicinal products (ATMPs), particularly cellular…
May / June 2024
The commercialization of personalized medicine has ushered in demand for a new type of facility—…
March / April 2024
Navigating the Asia Pacific Pharmaceutical Landscape for Global Impact Cover: The Asia Pacific…
Pharmaceutical Job Board
iSpeak Blog Posts
Professional Development Training
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. Course Price: $300 (non-member) / $270 (member) Buy Now Return to Online Learning
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. Buy Now Return to…
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.
GMP Refresher
Code of Federal Regulations (CFR) states that "Training in current good manufacturing practice shall be conducted by qualified individuals on a continuing basis and with sufficient frequency to assure that employees remain familiar with cGMP requirements applicable to them." This course will provide an overview of History, Regulations, Quality Systems, and development, with a focus on distinguishing between QA and QC in GMP. It can serve as a GMP refresher for both individuals and companies and ensures that current key trends are covered. CEUs are provided once you achieve an 80% passing grade…
Advancing Pharmaceutical Quality (APQ) Quality Management Maturity Training Course
The ISPE Advancing Pharmaceutical Quality (APQ) Program has been developed by industry representatives, for industry use, to provide a practical framework that organizations can use to assess and advance the state of quality within their organization. The APQ program recognizes that the ability to advance the maturity of quality management lies within the industry itself and provides a range of sustainable and practical quality management improvement strategies.
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