Journal Articles
Journal Article
Biopharma companies are grasping the key role an integrated product development strategy can play in the drug development process. A recent industry survey found growing uptake of this multidisciplinary approach to improving efficiency and reducing costs and timelines, though the barriers to successful implementation were similar across the board.
Journal Article
Pages 12-13. Annex 1 “Manufacture of Sterile Medicinal Products” was first published in 1971 and forms part of EudraLex Volume 41 that interprets the basic principles of GMP as detailed in European Directive 2003/94/ EEC.2 Annex 1 provides guidance on the minimum controls that are required to protect sterile medicinal products during manufacturing.
Journal Article
Quality Risk Management Why is QRM important for a pharmaceutical organization? What’s an efficient QRM program? How QRM is implemented and applied across the product life cycle? What is the correct way of implementing QRM?
Journal Article
Don’t settle for approximations, make smart, risk-based economic decisions. Bruno Boulanger explains how the application of Bayesian statistics can assist with decision making when data samples are small but pre-existing information is available.
Journal Article
Maintaining regulatory compliance across the product lifecycle, from product development through commercialisation and market compliance, is critical to ensuring the continuity of your operations. Whether your organisation is virtual or fully in-house, auditing is a mandatory component of maintaining regulatory compliance.
Journal Article
It has long been communicated to the UK pharmaceutical industry that the Prescription Medicines Code of Practice Authority (PMCPA) welcomes all input and feedback on the ABPI Code of Practice. But what does this actually mean, what does the PMCPA do with such feedback, and what motivates feedback or prevents it from being given?
Journal Article
The Prescription Medicines Code of Practice Authority (PMCPA) has received at least nine complaints to-date about the use of LinkedIn, indicating that its use, which is not specifically addressed in the ABPI Code of Practice (Code), may benefit from guidance on how to adhere to existing principles whilst also respecting the purpose of LinkedIn. This should help ensure the LinkedIn accounts and activities of pharmaceutical companies and pharmaceutical/agency employees, comply with the Code.
Journal Article
Rina Newton shares her top tips for ensuring agencies comply with the ABPI Code of Practice. Agencies are engaged by pharmaceutical companies because the expertise they offer may not be available in-house or because there is insufficient resource or time for in-house creation and development.
Journal Article
How does the ABPI Code apply to congresses? Mitigating the risks of breaching the Code. The ABPI Code of Practice provides guidance for pharmaceutical industry meetings and third-party meetings that the industry supports, covering meeting content and arrangements.
Journal Article
International Pharmaceutical Industry: Marta Vila Ramos discusses the impact of COVID-19 on the industry and what we can expect in the future.
Journal Article
Over the past 12 months, the bio/pharma industry has faced unprecedented challenges head on, working in unique and remote ways, and forming new and unlikely partnerships to help in the fight against the COVID-19 pandemic. Although a hugely impactful aspect of 2020, COVID-19 has not been the only trial of the year; bio/pharma companies have also had to keep a watchful eye on Brexit—the departure of the United Kingdom from the European Union—which is expected to cause broad-level disruptions to companies throughout the region.
Journal Article
Population pharmacokinetic (PK) models describe the drug concentration-time course in body fluids resulting from administration of a certain drug dose. Compartment models are typically used to conceptualize the mechanisms that take place in the interaction between an organism and a drug product.




