Weekly News

11 07, 2024

Tower Mains Weekly Newsletter 11th July 2024

11-July-2024|Weekly News|

Our weekly newsletter provides you with the latest industry news, developments and regulatory agency updates. Company Updates We are thrilled to announce that Erin Bell has been promoted to Senior Associate. Congratulations to Erin! We can't wait to see all the amazing things you'll achieve in your new role. Regulatory [...]

4 07, 2024

Tower Mains Weekly Newsletter 4th July 2024

04-July-2024|Weekly News|

Our weekly newsletter provides you with the latest industry news, developments and regulatory agency updates. Regulatory Updates FDA guidance updates Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products. On 28th June, the US Food & Drug Administration (FDA) published draft guidance intended to facilitate and [...]

27 06, 2024

Tower Mains Weekly Newsletter 27th June 2024

27-June-2024|Weekly News|

Our weekly newsletter provides you with the latest industry news, developments and regulatory agency updates. Regulatory Updates FDA guidance updates CVM GFI #288 Chemistry, Manufacturing, and Controls in Support of Recombinant Protein Products for Veterinary Medicinal Use. On 24th June, the US Food & Drug Administration (FDA) published draft guidance [...]

21 06, 2024

Tower Mains Weekly Newsletter 21st June 2024

21-June-2024|Weekly News|

Our weekly newsletter provides you with the latest industry news, developments and regulatory agency updates. Company Updates Tower Mains: Quality Assurance Services If you’re looking for flexible, pragmatic, and cost-effective Quality Assurance services... look no further! With over 200 years of combined experience, our team is on hand to provide [...]

13 06, 2024

Tower Mains Weekly Newsletter 13th June 2024

13-June-2024|Weekly News|

Our weekly newsletter provides you with the latest industry news, developments and regulatory agency updates. Company Updates Key Considerations for a Good Lab Investigation When things don’t go to plan in a laboratory, a good investigation is pivotal to understanding what went wrong and ensuring all necessary steps have been [...]

7 06, 2024

Tower Mains Weekly Newsletter 7th June 2024

07-June-2024|Weekly News|

Our weekly newsletter provides you with the latest industry news, developments and regulatory agency updates. Company Updates Key Considerations for a Good Lab Investigation When things don’t go to plan in a laboratory, a good investigation is pivotal to understanding what went wrong and ensuring all necessary steps have been [...]

30 05, 2024

Tower Mains Weekly Newsletter 30th May 2024

30-May-2024|Weekly News|

Our weekly newsletter provides you with the latest industry news, developments and regulatory agency updates. Regulatory Updates MHRA guidance updates International Recognition Procedure. On 24th May, the Medicines and Healthcare products Regulatory Agency (MHRA) added information and a new webinar link to guidance on how to use the procedure for [...]

23 05, 2024

Tower Mains Weekly Newsletter 23rd May 2024

23-May-2024|Weekly News|

Our weekly newsletter provides you with the latest industry news, developments and regulatory agency updates. Company Updates Top tips for choosing the right QA consultancy Is your organisation considering a QA consultancy? There are many reasons why your organisation may be in the market – including growing your services, staffing [...]

16 05, 2024

Tower Mains Weekly Newsletter 16th May 2024

16-May-2024|Weekly News|

Tower Mains Weekly Newsletter Company Updates Short Guide on Clinical QMS A Quality Management System (QMS) is a structured framework implemented to manage and maintain an organisation's quality objectives and expectations. It is pivotal in ensuring participant safety, data integrity, and compliance with regulatory standards. Our Senior Associate, Rita Silvestre [...]

9 05, 2024

Tower Mains Weekly Newsletter 9th May 2024

09-May-2024|Weekly News|

Tower Mains Weekly Newsletter Company Updates Short Guide on Clinical QMS A Quality Management System (QMS) is a structured framework implemented to manage and maintain an organisation's quality objectives and expectations. It is pivotal in ensuring participant safety, data integrity, and compliance with regulatory standards. Our Senior Associate, Rita Silvestre [...]

2 05, 2024

Tower Mains Weekly Newsletter 2nd May 2024

02-May-2024|Weekly News|

Tower Mains Weekly Newsletter Company Updates Katarina: Celebrating 10 years at Tower Mains Join us in celebrating a milestone as we honour Katarina Eghan, who is marking an incredible ten years with Tower Mains. Since joining our team in 2013, Katarina has made a huge impact on the company, bringing [...]

25 04, 2024

Tower Mains Weekly Newsletter 25th April 2024

25-April-2024|Weekly News|

Tower Mains Weekly Newsletter Company Updates Katarina: Celebrating 10 years at Tower Mains Join us in celebrating a milestone as we honour Katarina Eghan, who is marking an incredible ten years with Tower Mains. Since joining our team in 2013, Katarina has made a huge impact on the company, bringing [...]

17 04, 2024

Tower Mains Weekly Newsletter 17th April 2024

17-April-2024|Weekly News|

Tower Mains Weekly Newsletter Company Updates We Are Hiring: Principal Associate, Clinical QA Tower Mains is looking for an experienced individual to join our team in support of clinical audit and consultancy services supporting GCP training, audit, and client QAU and QMS development. The role is flexible and can be [...]

11 04, 2024

Tower Mains Weekly Newsletter 11th April 2024

11-April-2024|Weekly News|

Tower Mains Weekly Newsletter Company Updates We Are Hiring: Principal Associate, Clinical QA Tower Mains is looking for an experienced individual to join our team in support of clinical audit and consultancy services supporting GCP training, audit, and client QAU and QMS development. The role is flexible and can be [...]

4 04, 2024

Tower Mains Weekly Newsletter 4th April 2024

04-April-2024|Weekly News|

Tower Mains Weekly Newsletter Company Updates We Are Hiring: Principal Associate, Clinical QA We are looking for an experienced individual to join our team in support of clinical audit and consultancy services supporting GCP training, audit, and client QAU and QMS development. The role is flexible and can be adapted [...]

28 03, 2024

Tower Mains Weekly Newsletter 28th March 2024

28-March-2024|Weekly News|

Tower Mains Weekly Newsletter Company Updates We Are Hiring: Principal Associate, Clinical QA We are looking for an experienced individual to join our team in support of clinical audit and consultancy services supporting GCP training, audit, and client QAU and QMS development. The role is flexible and can be adapted [...]

21 03, 2024

Tower Mains Weekly Newsletter 21st March 2024

21-March-2024|Weekly News|

Tower Mains Weekly Newsletter Company Updates FDA, Health Canada, and MHRA GCP and Pharmacovigilance Symposium 2024 Missed out on the February 2024 FDA, Health Canada, and MHRA GCP and Pharmacovigilance Symposium? Don't worry, we've got you covered... from Data Integrity and Computer System Validation to technological innovations and patient-centric approaches, [...]

14 03, 2024

Tower Mains Weekly Newsletter 14th March 2024

14-March-2024|Weekly News|

Tower Mains Weekly Newsletter Company Updates We Are Hiring: Principal Associate, Clinical QA We are looking for an experienced individual to join our team in support of clinical audit and consultancy services supporting GCP training, audit, and client QAU and QMS development. The role is flexible and can be adapted [...]

8 03, 2024

Tower Mains Weekly Newsletter 8th March 2024

08-March-2024|Weekly News|

Tower Mains Weekly Newsletter Regulatory Updates MHRA guidance updates Innovative Devices Access Pathway (IDAP). On 29th February, the Medicines and Healthcare products Regulatory Agency (MHRA) added Data Protection and Privacy information to guidance on the Innovative Devices Access Pathway (IDAP), a pilot designed to accelerate the development of innovative medical [...]

29 02, 2024

Tower Mains Weekly Newsletter 29th February 2024

29-February-2024|Weekly News|

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 [...]

23 02, 2024

Tower Mains Weekly Newsletter 23rd February 2024

23-February-2024|Weekly News|

Company Updates SQA 40th Annual Meeting Exciting News! We are Exhibiting at SQA 40th Annual Meeting! Our Head of Quality Assurance Shona Ross will be heading to Colorado for the upcoming #SQA2024 40th Annual Meeting in April. Are you also attending? Come say Hi to Shona she will be at [...]

16 02, 2024

Tower Mains Weekly Newsletter 16th February 2024

16-February-2024|Weekly News|

Company Updates From Trainee to Trainer We are excited to share a milestone in the journey of our Senior Associate Rosemary Ichaba, recently she joined our Co-Founder Dr. Andrew Waddell as a course tutor for the Research Quality Association (RQA) Auditing Course. What makes this special is that for Rosemary [...]

8 02, 2024

Tower Mains Weekly Newsletter 8th February 2024

08-February-2024|Weekly News|

Tower Mains Weekly Newsletter Regulatory Updates MHRA guidance updates Paclitaxel coated devices (PCD) used in the treatment of peripheral arterial disease. On 5th February, the Medicines and Healthcare products Regulatory Agency (MHRA) published updated guidance on PCD used in the treatment of peripheral arterial disease. Following a review, the agency [...]

1 02, 2024

Tower Mains Weekly Newsletter 1st February 2024

01-February-2024|Weekly News|

Tower Mains Weekly Newsletter Regulatory Updates MHRA guidance updates Medicines that cannot be exported from the UK or hoard. On 30th January, the Medicines and Healthcare products Regulatory Agency (MHRA) updated the list of medicines that cannot be exported from the UK or hoarded. Click to view source Guidance on [...]

24 01, 2024

Tower Mains Weekly Newsletter 24th January 2024

24-January-2024|Weekly News|

Tower Mains Weekly Newsletter Regulatory Updates MHRA guidance updates Medical devices: UK-approved bodies. On 23rd January, the Medicines and Healthcare products Regulatory Agency (MHRA) added a new entry (International (UK) Ltd Medical Devices Scope) to the guidance on UK-approved bodies listed under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) [...]

18 01, 2024

Tower Mains Weekly Newsletter 18th January 2024

18-January-2024|Weekly News|

Tower Mains Weekly Newsletter Regulatory Updates MHRA guidance updates Project Orbis On 12th January, the Medicines and Healthcare products Regulatory Agency (MHRA) updated its guidance concerning Project Orbis and ILAP to express that it is no longer a requirement to obtain an Innovation Passport as part of the Project Orbis [...]

11 01, 2024

Tower Mains Weekly Newsletter 11th January 2024

11-January-2024|Weekly News|

Tower Mains Weekly Newsletter Company Updates Happy New Year from the Tower Mains team Happy New Year from the Tower Mains team. Thank you to all our clients and collaborators for your continued support, and here's to a fantastic year ahead! Regulatory Updates MHRA guidance updates Exporting active substances. On [...]

21 12, 2023

Tower Mains Weekly Newsletter 21st December 2023

21-December-2023|Weekly News|

Tower Mains Weekly Newsletter Company Updates Merry Christmas from the Tower Mains team A very Merry Christmas from the Tower Mains team. We would like to thank all our clients and collaborators for your support over the past year, and we look forward to working with you next year. We [...]

14 12, 2023

Tower Mains Weekly Newsletter 14th Dec 2023

14-December-2023|Weekly News|

Tower Mains Weekly Newsletter Regulatory Updates MHRA guidance updates International Recognition Procedure. On 8th December, the Medicines and Healthcare products Regulatory Agency (MHRA) added submission dates for Recognition B which align with CHM dates for New Active Substances (NAS). Click to view source COVID-19 test validation approved products. On 13th [...]

7 12, 2023

Tower Mains Weekly Newsletter 7th December 2023

07-December-2023|Weekly News|

Tower Mains Weekly Newsletter Regulatory Updates MHRA guidance updates Register medical devices to place on the market. On 1st December, the Medicines and Healthcare products Regulatory Agency (MHRA) provided clarification concerning fees and actions required to change the legislation of a registered device. Click to view source The Innovative Devices [...]

30 11, 2023

Tower Mains Weekly Newsletter 30th Nov 2023

30-November-2023|Weekly News|

Tower Mains Weekly Newsletter Regulatory Updates MHRA guidance updates Valproate use by women and girls. On 28th November, the Medicines and Healthcare products Regulatory Agency (MHRA) added information on the valproate registry to guidance on the risks of taking the drug during pregnancy. Click to view source Safety Public Assessment [...]

23 11, 2023

Tower Mains Weekly Newsletter 23rd November 2023

23-November-2023|Weekly News|

Tower Mains Weekly Newsletter Company Updates Good practices are good practices and at the core of this lies data integrity and the ability to use that to reconstruct what worked and what didn’t, which is why Tower Mains collaborated with Glasgow Caledonian University to reinforce why these – particularly good [...]

16 11, 2023

Tower Mains Weekly Newsletter 16th November 2023

16-November-2023|Weekly News|

Tower Mains Weekly Newsletter Company Updates  When things don’t go to plan in a laboratory, a good investigation is pivotal to understanding what went wrong and ensuring all necessary steps have been taken to identify the error, understand the root cause and prevent recurrence. Our new ‘Conducting Laboratory Investigations’ course [...]

9 11, 2023

Tower Mains Weekly Newsletter 9th November 2023

09-November-2023|Weekly News|

Tower Mains Weekly Newsletter Company Updates  New Course: Conducting Laboratory Investigations When things don’t go to plan in a laboratory, a good investigation is pivotal to understanding what went wrong and ensuring all necessary steps have been taken to identify the error, understand the root cause and prevent recurrence. Our [...]

3 11, 2023

Tower Mains Weekly Newsletter 3rd November 2023

03-November-2023|Weekly News|

Tower Mains Weekly Newsletter Company Updates  New Course: Conducting Laboratory Investigations When things don’t go to plan in a laboratory, a good investigation is pivotal to understanding what went wrong and ensuring all necessary steps have been taken to identify the error, understand the root cause and prevent recurrence. Our [...]

26 10, 2023

Tower Mains Weekly Newsletter 26th October 2023

26-October-2023|Weekly News|

Tower Mains Weekly Newsletter Company Updates New Course: Conducting Laboratory Investigations. When things don’t go to plan in a laboratory, a good investigation is pivotal to understanding what went wrong and ensuring all necessary steps have been taken to identify the error, understand the root cause and prevent recurrence. Our [...]

19 10, 2023

Tower Mains Weekly Newsletter 19th October 2023

19-October-2023|Weekly News|

Tower Mains Weekly Newsletter Company Updates New Course: Conducting Laboratory Investigations. When things don’t go to plan in a laboratory, a good investigation is pivotal to understanding what went wrong and ensuring all necessary steps have been taken to identify the error, understand the root cause and prevent recurrence. Our [...]

13 10, 2023

Tower Mains Weekly Newsletter 13th October 2023

13-October-2023|Weekly News|

Tower Mains Weekly Newsletter Company Updates New Course: Conducting Laboratory Investigations. When things don’t go to plan in a laboratory, a good investigation is pivotal to understanding what went wrong and ensuring all necessary steps have been taken to identify the error, understand the root cause and prevent recurrence. Our [...]

5 10, 2023

Tower Mains Weekly Newsletter 5th October 2023

05-October-2023|Weekly News|

Tower Mains Weekly Newsletter Regulatory Updates MHRA guidance updates International Recognition Procedure. On 3rd October, the Medicines and Healthcare products Regulatory Agency (MHRA) published a webinar providing information on guidance on the international recognition route for medicines utilising pre-existing approvals from Australia, Canada, the European Union, Japan, Switzerland, Singapore, and [...]

28 09, 2023

Tower Mains Weekly Newsletter 28th September

28-September-2023|Weekly News|

Tower Mains Weekly Newsletter Regulatory Updates MHRA issues latest Drug Safety Update newsletter On 26th September, the Medicines and Healthcare products Regulatory Agency (MHRA) issued the September issue of its Drug Safety Update newsletter from the agency and its independent advisor, the Commission on Human Medicines. Click to view source [...]

22 09, 2023

Tower Mains Weekly Newsletter 22nd September

22-September-2023|Weekly News|

Tower Mains Weekly Newsletter Regulatory Updates MHRA launches pathway for innovative technologies On 19th September, the Medicines and Healthcare products Regulatory Agency (MHRA) announced the launch of the Innovative Devices Access Pathway (IDAP), a program designed to accelerate the development of cost-effective medical devices and their integration into the UK [...]

14 09, 2023

Tower Mains Weekly Newsletter 14th September

14-September-2023|Weekly News|

Tower Mains Weekly Newsletter Regulatory Updates MHRA guidance updates Medicines: Apply for a parallel import licence. On 12th September, the Medicines and Healthcare products Regulatory Agency (MHRA) updated its guidance on getting a parallel import licence for medicines in the UK, including pharmacovigilance requirements and submitting an application. Click to [...]

7 09, 2023

Tower Mains Weekly Newsletter 7th September

07-September-2023|Weekly News|

Tower Mains Weekly Newsletter Company Updates MHRA guidance updates Export drugs and medicines: special rules. On 5th September, the Medicines and Healthcare products Regulatory Agency (MHRA) updated guidance on getting permission to export certain drugs and medicines. Details on applying for an export licence were removed and linked to the [...]

31 08, 2023

Tower Mains Weekly Newsletter 31st August 2023

31-August-2023|Weekly News|

Tower Mains Weekly Newsletter Regulatory Updates Revised Annex 1 Becomes Effective As of 25th August, the Annex 1 revision is finally operational, manufacturers in the EU must be compliant with the GMP guideline updates. Revision to the document has been made to reflect changes in regulatory and manufacturing environments. The [...]

24 08, 2023

Tower Mains Weekly Newsletter 24th August 2023

24-August-2023|Weekly News|

Tower Mains Weekly Newsletter Industry Updates EMA reviewing data on paternal exposure to valproate On 16th August, the European Medicines Agency (EMA) announced its Pharmacovigilance Risk Assessment Committee (PRAC) is reviewing data on the potential risk of neurodevelopmental disorders (NDDs) in children conceived by fathers taking valproate medicines. The review [...]

16 08, 2023

Tower Mains Weekly Newsletter 16th August 2023

16-August-2023|Weekly News|

Tower Mains Weekly Newsletter Regulatory Updates MHRA guidance updates MHRA performance data for assessment of clinical trials and established medicines. On 15th August, the Medicines and Healthcare products Regulatory Agency (MHRA) published performance metrics for clinical trials and established medicines assessment. Click to view source COVID-19 test validation approved products. [...]

10 08, 2023

Tower Mains Weekly Newsletter 10th August 2023

10-August-2023|Weekly News|

Tower Mains Weekly Newsletter Company Updates We are delighted to announce that we have moved our office to Newington Business Centre, 5, Dalkeith Road Mews, Edinburgh, EH16 5GA. We couldn't be more excited about the possibilities our new office will bring and as we settle into our new space, we [...]

3 08, 2023

Tower Mains Weekly Newsletter 3rd August 2023

03-August-2023|Weekly News|

Tower Mains Weekly Newsletter Company Updates We are delighted to announce that we have moved our office to Newington Business Centre, 5, Dalkeith Road Mews, Edinburgh, EH16 5GA. We couldn't be more excited about the possibilities our new office will bring and look forward to settling into our new home [...]

27 07, 2023

Tower Mains Weekly Newsletter 27th July 2023

27-July-2023|Weekly News|

Tower Mains Weekly Newsletter Regulatory Updates MHRA updates Annual conflicts of interest report. On 25th July, the Medicines and Healthcare products Regulatory Agency (MHRA) published its 2022 annual conflict of interest compliance report. This outlines the potential conflicts of interest (COI) arising from the operation of the three centres of [...]

21 07, 2023

Tower Mains Weekly Newsletter 21st July 2023

21-July-2023|Weekly News|

Tower Mains Weekly Newsletter Regulatory Updates MHRA guidance updates Register medical devices to place on the market. On 19th July, updated guidance and a template for extended CE certificate validity under EU MDR Article was added to the Medicines and Healthcare products Regulatory Agency (MHRA) guidance on registering medical devices [...]

12 07, 2023

Tower Mains Weekly Newsletter 12th July 2023

12-July-2023|Weekly News|

Tower Mains Weekly Newsletter Regulatory Updates MHRA guidance updates MHRA phase I accreditation scheme. On 10th July, the Medicines and Healthcare products Regulatory Agency (MHRA) updated the list of accredited phase I units in the guidance on joining the scheme. Click to view source Borderline products: how to tell if [...]

6 07, 2023

Tower Mains Weekly Newsletter 6th July 2023

06-July-2023|Weekly News|

Tower Mains Weekly Newsletter Regulatory Updates Timeframe for accepting CE-marked medical devices in Great Britain extended On 1st July, the Medicines and Healthcare products Regulatory Agency (MHRA) announced regulations (The Medical Devices (Amendment) (Great Britain) Regulations 2023) that enable CE-marked medical devices to be accepted in Great Britain for defined periods [...]

29 06, 2023

Tower Mains Weekly Newsletter 29th June 2023

29-June-2023|Weekly News|

Tower Mains Weekly Newsletter Regulatory Updates MHRA guidance updates Adrenaline auto-injectors: new guidance and resources for safe use. On 27th June, the Medicines and Healthcare products Regulatory Agency (MHRA) launched new guidance to highlight the latest safety advice on the steps to take during anaphylaxis. Click to view source Blood [...]

22 06, 2023

Tower Mains Weekly Newsletter 22nd June 2023

22-June-2023|Weekly News|

Tower Mains Weekly Newsletter Company Updates Meet our Senior Associate, Anna Lothian After graduating with a first-class honours degree in Biomedical Sciences from the University of Dundee, Anna began her career in the medical device field, starting as a lab technician and working towards a technical manager role in Research [...]

15 06, 2023

Tower Mains Weekly Newsletter 15th June 2023

15-June-2023|Weekly News|

Tower Mains Weekly Newsletter Company Updates As we approach the end of Q2, is 2023 flying by before your eyes? If you're still reviewing your audit program and identifying areas where you require support, why not let us help with your quality needs? Our team of experts has over 200 [...]

8 06, 2023

Tower Mains Weekly Newsletter 8th June 2023

08-June-2023|Weekly News|

Tower Mains Weekly Newsletter Company Updates Tower Mains blog: How to create a comfortable working environment as an auditor When describing an audit, the word ‘comfortable’ is not the first word that springs to mind, but why can’t this be a word associated with the auditing environment? Our Senior Associate, [...]

1 06, 2023

Tower Mains Weekly Newsletter 1st June 2023

01-June-2023|Weekly News|

Tower Mains Weekly Newsletter Company Updates ? Attention clinical researchers and trial sponsors! ? With the increased use of computerised systems in clinical trials, it is crucial that data integrity and patient safety are a top priority, and that the requirements for compliant data management are understood. Do you need [...]

24 05, 2023

Tower Mains Weekly Newsletter 24th May 2023

24-May-2023|Weekly News|

Tower Mains Weekly Newsletter Company Updates Meet our Training Associate Erin Bell. After graduating with an honour’s degree in Microbiology, Erin began her scientific career as a lab technician in a veterinary serology laboratory before transitioning to a global CRO to work in human clinical trials. From here, she progressed [...]

18 05, 2023

Tower Mains Weekly Newsletter 18th May 2023

18-May-2023|Weekly News|

Tower Mains Weekly Newsletter Company Updates Our brand-new course ‘Conducting Laboratory Investigations’ and our newly updated ‘Fundamentals of Good Manufacturing Practice’ course are now on the website and available to book. We currently have spaces available on the following training courses... 12th June 2023: Conducting Laboratory Investigations 13th-14th June 2023: [...]

11 05, 2023

Tower Mains Weekly Newsletter 11th May 2023

11-May-2023|Weekly News|

Tower Mains Weekly Newsletter Company Updates Do you want to further your knowledge in conducting laboratory investigations or understand more about the processes for planning, conducting, and reporting audits and inspections? With spaces available, it’s not too late to book one of our June courses… ? 12th June: Conducting Laboratory [...]

4 05, 2023

Tower Mains Weekly Newsletter 4th May 2023

04-May-2023|Weekly News|

Tower Mains Weekly Newsletter Company Updates Boost your skills and knowledge with one of our expert-led courses. With spaces available, it's not too late to book one of our May dates... ? 22nd May: Fundamentals of Good Laboratory Practice, led by Andrew Waddell ? 23rd May: Fundamentals of Good Clinical [...]

27 04, 2023

Tower Mains Weekly Newsletter 27th April 2023

27-April-2023|Weekly News|

Tower Mains Weekly Newsletter Regulatory Updates European Commission proposes pharmaceuticals reform for more accessible, affordable, and innovative medicines On 26th April, the European Commission proposed to revise the EU's pharmaceutical legislation - the largest reform in over 20 years – to make medicines more available, accessible, and affordable across the [...]

19 04, 2023

Tower Mains Weekly Newsletter 19th April 2023

19-April-2023|Weekly News|

Tower Mains Weekly Newsletter Regulatory Updates MHRA guidance updates MHRA performance data for assessment of clinical trials and established medicines. On 14th April, the Medicines and Healthcare products Regulatory Agency (MHRA) updated performance metrics for clinical trials and established medicines assessment. Click to view source Apply for the early access to [...]

13 04, 2023

Tower Mains Weekly Newsletter 13th April 2023

13-April-2023|Weekly News|

Tower Mains Weekly Newsletter Regulatory Updates  MHRA guidance updates Medicines: reclassify your product: On 6th April, the Medicines and Healthcare products Regulatory Agency (MHRA) updated the approved list of reclassifications in the guidance on applying to move a medicine to a different classification. Click to view source  Good clinical practice for clinical [...]

6 04, 2023

Tower Mains Weekly Newsletter 6th April 2023

06-April-2023|Weekly News|

Tower Mains Weekly Newsletter Regulatory Updates  MHRA guidance updates  Early access to medicines scheme (EAMS): scientific opinions: On 4th April, the Medicines and Healthcare products Regulatory Agency (MHRA) moved 'Lutetium (177Lu) vipivotide tetraxetan in the treatment of prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC)' to expired EAMS SO in [...]

30 03, 2023

Tower Mains Weekly Newsletter 30th March 2023

30-March-2023|Weekly News|

Tower Mains Weekly Newsletter Company Updates Meet our Senior Associate, Rosemary Ichaba Rosemary was introduced to QA after completing a Masters in Drug Discovery and Pharma Management and from here she branched out into Project Management, working within a Global CRO for two and a half years. Following this, she [...]

23 03, 2023

Tower Mains Weekly Newsletter 23rd March 2023

23-March-2023|Weekly News|

Tower Mains Weekly Newsletter Company Updates Tower Mains Training On 20-21st March, Founding Director Andrew Waddell debuted one of our new training courses for 2023 ‘Research Audit and Inspection’. Delegates in attendance included an experienced auditor, auditor in training, delegates who had experience in being audited and those with no exposure [...]

16 03, 2023

Tower Mains Weekly Newsletter 16th March 2023

16-March-2023|Weekly News|

Tower Mains Weekly Newsletter Company Updates Tower Mains’ Head of QA, Shona, is at the SQA’s 7th Global QA Conference Our Head of Quality Assurance, Shona Ross, has been having a great time at the Society of Quality Assurance’s 7th Global QA Conference in Washington DC this week.  She told [...]

9 03, 2023

Tower Mains Weekly Newsletter 9th March 2023

09-March-2023|Weekly News|

Company Updates Tower Mains takes on Belfast Last week, some of the team took on Belfast to celebrate Rhona's 50th birthday... here’s a little snippet of what they got up to. We hope you had a fantastic time celebrating your milestone birthday, Rhona! Regulatory Updates Q13 Continuous Manufacturing of Drug [...]

2 03, 2023

Tower Mains Weekly Newsletter 2nd March 2023

02-March-2023|Weekly News|

Tower Mains Weekly Newsletter Company Updates Tower Mains’ Shona Ross to attend and speak at the 7th Global QA Conference We are delighted that our Head of Quality Assurance Shona Ross will be attending and speaking at the 7th Global QA Conference in National Harbour. Shona will discuss how to [...]

23 02, 2023

Tower Mains Weekly Newsletter 23rd February 2023

23-February-2023|Weekly News|

Tower Mains Weekly Newsletter Company Updates Tower Mains’ Shona Ross to attend and speak at the 7th Global QA Conference We are delighted that our Head of Quality Assurance Shona Ross will be attending and speaking at the 7th Global QA Conference in National Harbour. Shona will be discussing how [...]

16 02, 2023

Tower Mains Weekly Newsletter 16th February 2023

16-February-2023|Weekly News|

Tower Mains Weekly Newsletter Company Updates Tower Mains welcomes Anna Lothian We are delighted to welcome Anna Lothian to the Tower Mains team. Anna joins us as Senior Associate and will be preparing and delivering audits for GLP, GMP and GCP compliance, helping deliver internal and external training and assisting [...]

9 02, 2023

Tower Mains Weekly Newsletter 9th February 2023

09-February-2023|Weekly News|

Tower Mains Weekly Newsletter Company Updates Tower Mains welcomes Erin Bell We are delighted to welcome Erin Bell to the Tower Mains team. Erin joins us as Associate and will be responsible for organising and managing our internal quality management systems and our internal and external training programmes. She will [...]

2 02, 2023

Tower Mains Weekly Newsletter 2nd February 2023

02-February-2023|Weekly News|

Tower Mains Weekly Newsletter Company Updates After a successful 2022, we are looking forward to further expanding our expert team, building on our range of services, and increasing our footprint in 2023 and beyond. With this in mind, we are delighted to announce changes to our Executive team: ? Senior [...]

26 01, 2023

Tower Mains Weekly Newsletter 26th January 2023

26-January-2023|Weekly News|

Tower Mains Weekly Newsletter Regulatory Updates FDA issues guidance for sponsors in the clinical development of drugs for the treatment of mpox  On 19th January, the US Food and Drug Administration (FDA) published draft guidance intended to support sponsors in their development of drugs for mpox. The guidance provides non-clinical, [...]

18 01, 2023

Tower Mains Weekly Newsletter 18th January 2023

18-January-2023|Weekly News|

Tower Mains Weekly Newsletter Regulatory Updates FDA signs MRA between US and Switzerland relating to GMP On 12th January, the US Food and Drug Administration (FDA) signed a Mutual Recognition Agreement (MRA) between the US and Switzerland, allowing the FDA and Swissmedic to share each other's GMP inspectional findings, reducing [...]

12 01, 2023

Tower Mains Weekly Newsletter 12th January 2023

12-January-2023|Weekly News|

Tower Mains Weekly Newsletter Regulatory Updates MHRA extends consultation on how it communicates with healthcare professionals to improve medicines and medical devices’ safety On 6th January, the Medicines and Healthcare products Regulatory Agency (MHRA) extended the deadline for the consultation on how the agency communicates with healthcare professionals. It will [...]

5 01, 2023

Tower Mains Weekly Newsletter 5th January 2023

05-January-2023|Weekly News|

Tower Mains Weekly Newsletter Regulatory Updates MHRA guidance update: Exceptional use of non-UKCA marked medical devices On 30th December, the Medicines and Healthcare products Regulatory Agency (MHRA) updated the application form in its guidance on how a manufacturer can apply for approval to supply a non-compliant medical device on humanitarian [...]

20 12, 2022

Tower Mains Weekly Newsletter 20th Dec 2022

20-December-2022|Weekly News|

Tower Mains Weekly Newsletter Regulatory Updates MHRA guidance updates On 14th December, the Medicines and Healthcare products Regulatory Agency (MHRA) updated its guidance providing innovators and developers of innovative products access to MHRA scientific expertise, regulatory guidance, and enhanced advice. Click to view source On 19th December, the MHRA added [...]

14 12, 2022

Tower Mains Weekly Newsletter 14th Dec 2022

14-December-2022|Weekly News|

Tower Mains Weekly Newsletter Regulatory Updates MHRA guidance updates On 9th December, the Medicines and Healthcare products Regulatory Agency (MHRA) updated guidance on how to get a parallel import licence in the UK, including pharmacovigilance requirements and submitting an application. Click to view source On 13th December, the list of [...]

7 12, 2022

Tower Mains Weekly Newsletter 7th Dec 2022

07-December-2022|Weekly News|

Tower Mains Weekly Newsletter Regulatory Updates MHRA guidance updates  On 5th December, the Medicines and Healthcare products Regulatory Agency (MHRA) updated information for manufacturers of medical devices about reporting adverse incidents and field safety corrective actions to the MHRA. Click to view source  On 6th December, guidance was updated on [...]

1 12, 2022

Tower Mains Weekly Newsletter 1st Dec 2022

01-December-2022|Weekly News|

Tower Mains Weekly Newsletter Regulatory Updates MHRA updates data on clinical trials for medicines On 29th November, the Medicines and Healthcare products Regulatory Agency (MHRA) updated data on the time taken by the agency to assess clinical trial applications and substantial amendments. Click to view source FDA issues draft guidance [...]

23 11, 2022

Tower Mains Weekly Newsletter 23rd Nov 2022

23-November-2022|Weekly News|

Tower Mains Weekly Newsletter Company Updates Scotsman Life Sciences Conference 2022 Tower Mains is delighted to be exhibiting at the Scotsman Life Sciences Conference 2022 this Thursday 24th November in Glasgow. If you’re there, pop along to our stand for a chat… our Head of QA Shona Ross, and Head [...]

16 11, 2022

Tower Mains Weekly Newsletter 16th Nov 2022

16-November-2022|Weekly News|

Tower Mains Weekly Newsletter Company Updates RQA RE: UNITED International Conference We were delighted to attend and participate in the Research Quality Association (RQA) RE: UNITED International Conference last week. It was great to see so many new and familiar faces! To view our Quality ASAP poster, click here. Regulatory Updates Q5A(R2) [...]

9 11, 2022

Tower Mains Weekly Newsletter 9th November 2022

09-November-2022|Weekly News|

Tower Mains Weekly Newsletter Company Updates RQA RE: UNITED International Conference We are delighted to be attending the Research Quality Association (RQA) RE: UNITED International Conference, 9th-11th November 2022. If you’re there, make sure to visit booth #16 for a chat and to help us celebrate our 21st birthday with [...]

2 11, 2022

Tower Mains Weekly Newsletter 2nd November 2022

02-November-2022|Weekly News|

Tower Mains Weekly Newsletter Regulatory Updates MHRA guidance updates On 28th October, guidance on how the Medicines and Healthcare products Regulatory Agency (MHRA) approaches pharmacovigilance procedures was updated to include further details on submission requirements, in particular relating to signals. Click to view source On 28th October, MHRA guidance on [...]

26 10, 2022

Tower Mains Weekly Newsletter 26th October 2022

26-October-2022|Weekly News|

Tower Mains Weekly Newsletter Industry Updates EMA recommends approval of second adapted Spikevax vaccine On 19th October, the European Medicines Agency (EMA) announced its human medicines committee (CHMP) has recommended authorising an adapted Spikevax COVID-19 vaccine targeting the Omicron subvariants BA.4 and BA.5 in addition to the original strain of [...]

19 10, 2022

Tower Mains Weekly Newsletter 19th October 2022

19-October-2022|Weekly News|

Tower Mains Weekly Newsletter Regulatory Updates MHRA updates guidance on its Software and AI as a Medical Device Change Programme On 17th October, the Medicines and Healthcare products Regulatory Agency (MHRA) added a roadmap to the guidance on its programme of reform to ensure that medical device regulation is fit [...]

12 10, 2022

Tower Mains Weekly Newsletter 12th October 2022

12-October-2022|Weekly News|

Tower Mains Weekly Newsletter Regulatory Updates ICH E19 Guideline reaches Step 4 of the ICH Process On 4th October, the International Council for Harmonisation (ICH) announced the ICH E19 Guideline on A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-approval or Post-Approval Clinical Trials reached Step 4 of [...]

5 10, 2022

Tower Mains Weekly Newsletter 5th October 2022

05-October-2022|Weekly News|

Tower Mains Weekly Newsletter Regulatory Updates MHRA appoints first UK Approved Body to certify medical devices since Brexit On 29th September, the Medicines and Healthcare products Regulatory Agency (MHRA) confirmed that DEKRA Certification UK Ltd has joined the three current UK Approved Bodies, increasing the UK’s capacity to process conformity [...]

28 09, 2022

Tower Mains Weekly Newsletter 28th September 2022

28-September-2022|Weekly News|

Tower Mains Weekly Newsletter Regulatory Updates FDA publishes draft guidance aiming to protect children who participate in clinical trials  On 23rd September, the US Food and Drug Administration (FDA) issued draft guidance that, when finalised, will provide the agency’s perspective on the ethical considerations for including and protecting children in [...]

21 09, 2022

Tower Mains Weekly Newsletter 21st September 2022

21-September-2022|Weekly News|

Tower Mains Weekly Newsletter Regulatory Updates EMA and HMA confirm biosimilar medicines can be interchanged On 19th September, the EMA and the Heads of Medicines Agencies (HMA) issued a joint statement confirming that biosimilar medicines approved in the EU are interchangeable with their reference medicine or with an equivalent biosimilar. [...]

14 09, 2022

Tower Mains Weekly Newsletter 14th September 2022

14-September-2022|Weekly News|

Tower Mains Weekly Newsletter Industry Updates EMA approves adapted vaccine targeting BA.4 and BA.5 Omicron variants and original SARS-CoV-2 On 12th September, the European Medicines Agency (EMA) announced its human medicines committee (CHMP) has recommended authorising an adapted bivalent vaccine targeting the Omicron subvariants BA.4 and BA.5 in addition to [...]

7 09, 2022

Tower Mains Weekly Newsletter 7th September 2022

07-September-2022|Weekly News|

Tower Mains Weekly Newsletter Industry Updates First adapted COVID-19 booster vaccines recommended for approval in the EU  On 1st September, the European Medicines Agency (EMA) announced its human medicines committee (CHMP) has recommended authorising two vaccines adapted to provide broader protection against COVID-19. Comirnaty Original/Omicron BA.1 and Spikevax bivalent Original/Omicron [...]

31 08, 2022

Tower Mains Weekly Newsletter 31st August 2022

31-August-2022|Weekly News|

Tower Mains Weekly Newsletter Company Updates Check out our latest ‘Meet the Team’ blog post on our Head of Clinical & Quality Management, Marina Freiberga. Marina tells us what initially attracted her to QA, her career highlights, and what makes her tick outside of work. Click here. Industry Updates EU [...]

24 08, 2022

Tower Mains Weekly Newsletter 24th August 2022

24-August-2022|Weekly News|

Tower Mains Weekly Newsletter Company News Risk Management in your Quality Management System (QMS) – is it effective? In their first Linkedin live short webinar series our QMS team discusses: The effectiveness of a risk-based approach Best practices for incorporating quality risk management into your organisation’s processes The full video [...]

17 08, 2022

Tower Mains Weekly Newsletter 17th August 2022

17-August-2022|Weekly News|

Tower Mains Weekly Newsletter Company Updates We have been published in the August issue of QUASAR, the Research Quality Association (RQA)'s renowned membership magazine. Check out our article on how some of the Tower Mains team made the transition to QA consultancy, here. Industry Updates FDA grants accelerated approval to [...]

10 08, 2022

Tower Mains Weekly Newsletter 10th August 2022

10-August-2022|Weekly News|

Tower Mains Weekly Newsletter Company Updates We have exciting news! Tower Mains is delighted to announce the following promotions:   Our Associate Director and Head of Operations Lianne Roeling will be expanding her Business Development role, specifically to support the growth of our training services.   Naomi Ervine who has been promoted [...]

3 08, 2022

Tower Mains Weekly Newsletter 3rd August 2022

03-August-2022|Weekly News|

Tower Mains Weekly Newsletter Regulatory Updates International Council on Harmonisation (ICH) M10 Guideline Issued On 27th July, final ICH M10 guideline on Bioanalytical Method Validation and Study Sample Analysis has been published. This guideline provides recommendations for the validation of bioanalytical methods and their application in the analysis of study [...]

27 07, 2022

Tower Mains Weekly Newsletter 27th July 2022

27-July-2022|Weekly News|

Tower Mains Weekly Newsletter Industry Updates EMA to hold second Veterinary Big Data Stakeholder Forum Following the success of the 2021 stakeholder forum, the European Medicines Agency (EMA) has announced the second Veterinary Big Data Stakeholder Forum, scheduled for Wednesday, 23rd November 2022. Driven by the principles embraced by the [...]