Journal Articles related to Regulatory Affairs and CMC
Journal Article
- November 14, 2022
Like the previous workshops, this event was characterized by a mix of presentations on specific Annex 1 topics combined with interactive workshops, whereby participants had the opportunity to ask the panel of experts about the presented subjects. Above all, it provided the opportunity to discuss the participant’s interpretation, challenges and possible solutions with peers from the industry. Based on the number of questions asked of the panel, this turned out to be a very successful workshop with a high level of interaction between participants and presenters and during round-table discussions.
Journal Article
- April 21, 2021
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
- April 21, 2021
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
- April 21, 2021
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
- April 21, 2021
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
- September 15, 2020
Teknoscienze – Chemistry Today: Barbara Siebertz and Ute Hegener look at the national legal requirements of some European countries on medicinal cannabis, while highlighting the differences within the EU.
Journal Article
- August 31, 2020
Nutraceutical Business Review: Barbara Siebertz and Ute Hegener discuss the current legal and marketing situation in Europe
Journal Article
- August 31, 2020
International Clinical Trials: Improving the chances of EU approval – Lisa Pascoe and Lucy Gluyas discuss the steps required to ensure a successful Clinical Trial Application (CTA)
Journal Article
- May 28, 2020
PharmaLex.pert Diego Martinez discusses why industry must never become complacent about the safety of drug products and should seek to continually perform surveillance even if the drug is well-established.