...or an over-arching one specific to COVID-19. The ultimate aim should be to ensure the medicines provided to patients remain safe and effective and the integrity of the supply chain...
...conduct and integrity of clinical trials of medicines during COVID-19. We collaborated with our wider national and international network in relation to trials and healthcare in general. For example, we...
...chain integrity. Any unsolicited offers for products should be treated with extra caution, particularly a cold call approach where a supplier appears eager or rushed to sell the stock on....
...integrity inspections and seen at several pharmacies that hold wholesale dealer licences prescriptions presented to the MAH to obtain medicines. These medicines are received and then sold on for parallel...
...the Cogent approval process. We believe this will raise the profile of the role and contribute significantly to the integrity of the medicines supply chain in the UK. Choosing an...
...a key role in delivering presentations, leading workshops and contributing to group discussions. MHRA led sessions on the following diverse topics: data mining techniques for reviewing case processing activities on...
...Referral to Enforcement if evidence found of – fraudulent data, harmful product, falsified medicines. Third country sites do not hold Manufacturing Authorisations (MIA) but are still subject to inspection and...
...marketing regulatory commitments are not applicable. However, the requirement that ongoing stability data should continue to support QP certification is equally applicable to IMPs and licensed products. Finally, section 1.7.21...
...metrics data highlighted some common themes. This post shared these examples to help organisations to identify if these issues could occur at their own facilities and allow them to pro-actively...
...Our objectives on inspection revolve around getting a clear picture of the processes and data that make up your pharmacovigilance system. A successful inspection for us is one where we...
