We are delighted to announce that Colin MacDonald PCQI, LRSC, APM will be joining the Tower Mains team as Principal Associate. Colin will be assisting and supporting clients in the selection, design, and implementation of Quality Management Systems in accordance with their desired regulatory and/or accreditation standards.
MHRA publishes the Pharmacovigilance inspection metrics 2019/2020
On 3rd March 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) GPvP inspectorate published the Pharmacovigilance inspection metrics from April 2019 until March 2020.
MHRA publishes report on COVID-19 vaccine adverse reactions
On 4th March 2021, the MHRA published a report covering adverse reactions to approved COVID-19 vaccines. The report includes data from 9th December 2020 until 21st February 2021.
MHRA releases ACCESS Consortium guidance on strain changes in COVID-19 vaccines
On 4th March 2021, the MHRA published guidance on the regulatory approach to updating coronavirus vaccines, should mutations at any time make them less effective due to insufficient cross-reactivity. This is only applicable to COVID-19 vaccines which have already been authorised, based on sufficient data on pharmaceutical quality, safety, and efficacy from clinical trials.
FDA Authorises Adaptive Biotechnologies T-Detect COVID Test
On 5th March 2021, the FDA issued an emergency use authorization (EUA) for the T-Detect COVID Test developed by Adaptive Biotechnologies. The T-Detect COVID Test is a next-generation sequencing-based (NGS) test to aid in identifying individuals with an adaptive T cell immune response to SARS-CoV-2, indicating recent or prior infection with SARS-CoV-2.
EMA announces Veterinary Big Data Stakeholder Forum
On 10th March 2021, European Medicines Agency (EMA) announced a “Veterinary Big Data Stakeholder Forum” to be held virtually on 1st-2nd June 2021. In line with the European Network of Medicines Agency (EMAN) Strategy to 2025, they would like to bring together regulators, the pharmaceutical industry, farm management system providers, academia, consumers, and practitioners, to build awareness on the use of innovative technology and share opportunities.
FDA Green-Lights Emergency Use of Janssen’s Single Shot COVID-19 Vaccine
The U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorisation to the Janssen Pharmaceutical Companies of Johnson & Johnson’s single-dose COVID-19 vaccine. Supporting data showed that the vaccine was 85% effective in preventing severe disease and provided protection against hospitalisation and death. Back in December, the company announced filing a submission to the EMA.
Issue Number: WN0001
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