News
Many challenges face the multicultural auditor today… @ RQA 2020
Many challenges face the multicultural auditor today… Which is why our Director Andrew Waddell chose to shed some light on the topic at the #RQA2020 International QA Conference on Tuesday. [...]
Pharma News Update October 2020
COVID-19 Vaccine Development MHRA Initiates Rolling Review of Moderna’s mRNA Vaccine Against COVID-19 On 27th October 2020, Moderna, a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, announced that [...]
Regulatory News Update October 2020
Medicines and Healthcare products Regulatory Agency (MHRA) Updated guidance on Clinical Trial Applications for Coronavirus (COVID19) On 5th October 2020, the MHRA added new information to the guidelines on Clinical [...]
Pharma News Update September 2020
COVID-19 Vaccine Development AstraZeneca Under Fire for COVID-19 Vaccine Safety, Releases Trial Protocol Following scrutiny over a potential patient side effect that prompted a clinical hold of its Phase III [...]
Pharma News Update August 2020
COVID-19 Vaccine Development EC Signs COVID-19 Vaccine Contract with AstraZeneca On 27th Aug 2020, the European Commission (EC) announced that it had signed its first contract with AstraZeneca for the [...]
Regulatory News Update August 2020
MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY (MHRA) Update on MHRA Regulatory Flexibilities Resulting from Coronavirus (COVID-19) Guidance The update on the Guidance was published on 4th August 2020. The MHRA [...]
OECD Advisory Document on GLP Data Integrity
On 07 August 2020, the OECD made available their long-awaited OECD Draft Advisory Document on GLP Data Integrity for public comment. The document gives guidance on; the responsibilities from data [...]
MHRA GCP Guidance for Clinical Trials
On 31st July 2020 MHRA updated “Good clinical practice for clinical trials” on their website available here. Guidance for the notification of serious breaches of GCP or the trial protocol, [...]
Pharma News Update July 2020
COVID-19 Vaccine Development Dynavax and Medigen Announce Partnership for a Novel Adjuvanted COVID-19 Vaccine Candidate On 23rd July 2020, Dynavax Technologies, a biopharmaceutical company focused on developing and commercialising novel [...]
Regulatory News Update July 2020
Medicines and Healthcare products Regulatory Agency (MHRA) Updates on MHRA Regulatory Flexibilities resulting from Coronavirus (COVID-19) guidelines The MHRA issued additional updates to the guidelines in July 2020. Information for [...]
