Company Updates
Vacancy: Senior or Principal Clinical Auditor
Are you a clinical auditor looking for a new role? We are looking for someone with experience in clinical trials, quality systems and audits to join our dynamic team.
We’re looking for someone who is able to:
- Deliver GCP training to all roles and experience levels in clinical trials from startups and biotech to investigators and CRAs in pharma.
- Support QMS development for our clients, from those just starting out who know and have nothing, to those looking to update, streamline or review their processes against the regulatory landscape.
- Conduct audits independently throughout Europe and potentially globally.
Please note: You should have the right to work in the UK and hold a full driving licence.
Interested in working for us?
Tower Mains Limited is proud of our reputation as a high-quality international provider of Quality Assurance and Clinical / Quality Management consultancy services, if you’re interested in working for us, please don’t hesitate to contact us in confidence at careers@towermains.com with a copy of your CV.
What can we offer you?
We offer ample opportunities for career growth and development, and offer full-time, part-time, and flexible contracts so that you can build your job around family and other commitments. Maintaining a healthy work-life balance is important to us, and taking time away from work for rest and relaxation is essential, and we encourage our team to make use of personal improvement time or ‘PIT’ days – in addition to their annual leave entitlement – to switch off and recharge. This equates to, on average, an additional day off each month.
Regulatory Updates
MHRA Updates
Blood Bank Compliance Report Template On 26th February, the Medicines and Healthcare products Regulatory Agency (MHRA) issued updated templates for a blood bank compliance report including guidance for 2024.
Dame June Raine, MHRA’s Chief Executive Stepping Down from the Role in the Autumn of 2024. The MHRA announced that Dame June Raine, Chief Executive of the MHRA will be stepping down in the Autumn following five years in the role. Dame June Raine came into office at a critical time, only four months before the UK pulled out of the European Union under Brexit, leading to a sea change in regulations. Her appointment was followed just a few months later by the COVID-19 outbreak, leading the agency to scramble to find drugs, vaccines, and diagnostics to address the global pandemic.
Field Safety Notices: 19 to 23 February 2024 On 27th February, the MHRA updated its field safety notices, a field safety notice from CooperSurgical on Origo Sperm Wash Media was added.
Established Medicines Marketing Authorisation Application Process Changes. On 28th February, the MHRA announced new guidance to help applicants and shorten time frames for assessment of established medicines. The new guidance will be effective from the 1st of March 2024, the changes to the process will allow the MHRA to be able to assess applications more efficiently, helping to ensure a smoother and more rapid approvals process for applicants.
FDA Guidance Updates
Reporting Amount of Listed Drugs and Biological Products Technical Conformance Guide: Guidance for Industry. On 26th February, the US Food and Drug Administration (FDA) issued final guidance, describing the data elements that should be submitted for reporting information under section 510(j)(3) by each person who registers with FDA under section 510 of the FD&C Act concerning a listed drug.
EMA Updates
Scientific Advice and Protocol Assistance. On 22nd February, the European Medicines Agency (EMA) issued a report on the status of requests for scientific advice procedures adopted during the Committee for Medicinal Products for Human Use (CHMP) meeting 19-22 February 2024.
Clinical Trials Information System (CTIS): Walk-in Clinic. On 26th February, EMA announced an online walk-in clinic on CTIS functionalities providing an opportunity for sponsors to ask questions to CTIS experts in real time on 12th March 2024.
Multi-stakeholder Webinar on the HMA-EMA Catalogues of Real-world Data Sources and Studies Webinar on the newly published catalogues for real-world data sources and studies taking place on 4th March 2024, providing an overview of the catalogues including their benefits and significance in regulatory practices.
PSUSA/00001507/202304 – Periodic Safety Update Report Single Assessment. On 29th February, periodic safety reports on gadoteridol were made available:
- List of nationally authorised medicinal products
- Annex I Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation(s)
Australia’s TGA Joins International Peers to Pilot GMP Single Inspection Program
On 20th February 2024, Australia’s Therapeutic Goods Administration (TGA) announced it had begun piloting a good manufacturing practice (GMP) single inspection program (SIP) with its international peers.
TGA joined with all members of the Pharmaceutical Inspection Co-operation Scheme (PIC/S), International Coalition of Medicines Regulatory Authorities (ICMRA) and Access Consortium for the project. This project aims to establish a coordinated global approach to GMP inspections of foreign manufacturing sites of common interest.
Industry Updates
First Oral Treatment for Patients with Paroxysmal Nocturnal Haemoglobinuria
On 23rd February 2024, the EMA recommended granting a marketing authorisation in the European Union for Voydeya, the first oral treatment for patients with paroxysmal nocturnal haemoglobinuria (PNH) who continue to have haemolytic anaemia despite treatment with a C5 complement inhibitor. PNH is a genetic disorder leading to haemolytic anaemia, EMA’s recommendation was based on the results of a randomised, double-blind, placebo-controlled phase III study in 86 patients with PNH and clinically significant evidence of residual haemolytic anaemia.
Vest Can Detect Earlier Signs of Heart Muscle Disease
Researchers from University College London (UCL) have developed a reusable electrocardiographic imaging (ECGI) vest to detect early signs and abnormalities in hypertrophic cardiomyopathy. The study was published in the Journal of the American College of Cardiology, the ECGI vest was able to detect electrical changes associated with an inherited heart muscle condition at a stage when standard tests do not pick up signs of disease.
FDA Grants Priority Review of Epcoritamab (EPKINLY®) for Difficult-to-Treat Relapsed or Refractory Follicular Lymphoma
On 27th February 2024, AbbVie announced that the FDA granted Priority Review of the supplemental Biologics License Application (sBLA) for epcoritamab-bysp, a subcutaneously administered T-cell engaging bispecific antibody for the treatment of adult relapsed or refractory( R/R) follicular lymphoma after two or more lines of therapy. If approved, epcoritamab-bysp (EPKINLY®) will be the first and only subcutaneous bispecific antibody to treat adults marking its second indication following FDA and EMA approval of R/R third-line diffuse large B-cell lymphoma (DLBCL) treatment.
Viking Therapeutics Obesity Drug Hits Target in Key Study
On 27th February 2024, Viking Therapeutics, a biopharmaceutical company focused on metabolic and endocrine disorders, announced positive results from the phase II trial of VK2735 as part of the development of a potential treatment for obesity. Subjects receiving VK2735 showed a statistically significant reduction in body weight in comparison with the placebo group.
FDA to Increase Inspections of Drug Manufacturing Units in India
On 27th February 2024, the FDA announced a boost in the number of inspections at Indian drug manufacturing units in 2024 amid growing concerns over the quality of drugs. This is a consequence of India’s work to grow its pharmaceutical industry’s global presence. Last year the World Health Organisation had previously linked cases of paediatric patients admitted to the hospital due to medicines containing extremely dangerous levels of toxins which also had been sold in bottles wrongly labelled as WHO-approved.
Issue Number: WN00151
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