Open for consultation: EMA draft reflection paper on the use of artifi
EMA has published a draft reflection paper outlining the current thinking on the use of artificial intelligence (AI) to support the safe and effective development, regulation and use of human and veterinary medicines. This paper, which is now open for public consultation, reflects on principles relevant to the application of AI and machine learning (ML) at any step of a medicines’ lifecycle, from drug discovery to the post-authorisation setting.
All interested stakeholders are invited to comment on the draft reflection paper and to identify opportunities and risks of AI in the field of medicines. The public consultation is open until 31 December 2023 and the topic will be further discussed during a joint HMA/EMA workshop scheduled for 20-21 November 2023. The feedback from stakeholders will be analysed and considered for the finalisation of the reflection paper and future development of guidance as relevant.
Wednesday 19th July 2023

JPAG App released
The JPAG App is now available for you to install on your phone and tablets and use on your computers.

The app is free for all, and is the quickest way to access information on JPAG events and get to recent Newsletters as well as find out your membership details, or how to join for non-members.

The app is not available on the App Stores; to install, follow these simple instructions to install it on your device.

We hope you find it as useful as we do.
Thursday 8th June 2023

New electron diffraction facility at National Crystallography Service
We are pleased to announce that the EPSRC-funded UK National Crystallography Service (NCS) is now able to offer electron diffraction facilities.

Electron diffraction is a rapidly growing technique capable of rapidly obtaining structures of nanocrystalline materials. There will soon be two dedicated electron diffractometers in the UK, at the Universities of Warwick and Southampton, operating as a national service for the whole scientific community as part of the NCS. A third instrument will be installed at the University of Glasgow in 2024. This ‘first of its kind’ facility will provide cutting-edge capabilities to obtain single crystal structures from nanocrystals (powders and crystallites <1 micron). The facility will be available free of charge to UK academics who are eligible to apply for EPSRC funding. Applications for access to the Electron Diffraction Facility are open now using the same mechanism as all the other NCS services (see https://www.ncs.ac.uk/access/ for details of all available services).

More information about the electron diffraction facility, including the application process, can be found at http://www.ncs.ac.uk/nedf. The next service period will run from 1st Jul – 31st Dec 2023 and the call will close on 31st May at 23:00. The NCS team would appreciate it if you could circulate this email as widely as possible among your colleagues.
To register your interest as a new user for the upcoming period, please email info@ncs.ac.uk and include your name, email address, and department/institution. After receiving your email, we will register you on our Portal2 system and send you a password reset. Once you are logged on you can submit a short application that includes some information about the project and expected use.

If you have any questions about the application process, the NCS facility, or anything else, please contact the team at info@ncs.ac.uk or visit http://www.ncs.ac.uk/ for further information.
Thursday 25th May 2023

JPAG Pharmaceutical Analysis Research Awards and Careers Fair 2022
It has been another very successful year for the Pharmaceutical Analysis Research Awards and Careers Symposium which was held on Tuesday. 22nd November 2022, the first held with a live audience since Covid-19. Over 100 delegates attended the meeting and heard two highly inspirational keynote lectures by Dr Tony Bristow, AstraZeneca, and by Professor Paul Thomas, Loughborough University.
There were also eight high-quality podium presentations by early career PhD and industrial researchers. In the Science Room at Burlington House were 22 posters, attended by the authors.
The winner of THE GEOFFREY PHILLIPS ANALYTICAL SCIENCE AWARD for the best podium presentation has been announced. The winner was Miss Georgina Armstrong, GSK, who gave her presentation on "Sequence engineering of monoclonal antibodies to reduce the viscosity of high concentration formulations; an in silico approach to viscosity predictions for IgG Fvs". Georgina received a certificate and a bursary of up to £1,000 to enable her to benefit from a relevant programme of personal professional development, and a further £100 donated by the Royal Society of Chemistry.
The highly commended podium award of £250 was made to Miss Lucy Durham, Pharmaron, for her presentation on "Method development for the detection and quantification of six nitrosamines from water-based rinsates by triple quadropole liquid chromatography mass spectroscopy".
The winner of the best poster award of £200 was Miss Phebie Watson, Liverpool John Moores University, for her presentation on "Evaluating attenuated total reflectance Fourier transform infrared and near infrared spectroscopy for classifying M. musculus grave soil in the presence of clothing material".
Commended poster awards, each of £100 ,were made to Mr Ashraf Qasem, University of Bath, for his presentation on "The effect of position 1 substituent and config...
More...
Thursday 24th November 2022

Guidance on the Characterisation of the particle population in AAV ...
The quality of a medicine is critical to ensuring its safety and efficacy, and therefore the medicine’s suitability for patients. The use of analytical techniques is a vital component in the assurance of medicines quality. Identified as a priority...

For colleagues in the ATMP community. The BP team at MHRA has opened a consultation on new guidance for the characterisation of the particle population in AAV products. Details in the link below, closing date 31st Jan 2023.
CLICK HERE for more details.
Thursday 24th November 2022

RPS calls for changes in research of controlled drugs
The Royal Pharmaceutical Society has responded to a consultation from the Advisory Council on the Misuse of Drugs regarding the legal constraints on researching controlled drugs.
In the response, we call for barriers that restrict legitimate research with controlled drugs, other than synthetic cannabinoids, to be removed. We’ve also highlighted that allowing flexibility around licensing, storage, formulation and the clinical supply of controlled drugs would facilitate more fundamental research to occur in the UK. RPS Chief Scientist Professor Gino Martini said:
“The UK is a world-leader in the life sciences sector. It’s important we’re given the best opportunity to support the development of new medicines that can help patients get the treatment that they need. We need to make the most of our incredible pharmaceutical infrastructure and ensure it’s easier to gain licences for the research of controlled drugs, which ultimately can help to enhance patient care.”
More information on our consultation response : Call for Evidence – Barriers to research for controlled drugs.
Friday 14th May 2021

Consultation on improving tests in BP monographs
As part of the BP's continued work to ensure their products and services remain relevant, easy to use and cost-effective, they are proposing changes to improve tests used in their monographs.
They have prepared the following items for consultation with their users, and would like your views.
LC-DAD
LC-PAD
Expression of related substances limits

JPAG are looking for specific comments from members on these that will be subsequently forwarded to BP.
FULL DETAILS AND ADD YOUR COMMENT HERE
Friday 3rd July 2020

Patient adherence; the true costs
Here is another article in the series reproduced with permission from the European Pharmaceutical Review. It is entitled "Patient adherence; the true costs" written by Dr Dave Elder, Past-Chairman of the JPAG Committee Download the article
Wednesday 1st July 2020

Covid-19 a wakeup call?
Here is another article in the series reproduced with permission from the European Pharmaceutical Review. It is entitled "Covid-19 a wake-up call" written by Dr Dave Elder, Past-Chairman of the JPAG Committee Download the article
Monday 20th April 2020

The role of ELSIE in evolving current thinking on extractables and lea
Here is another article in the series reproduced with permission from the European Pharmaceutical Review. It is entitled "The role of ELSIE in evolving current thinking on extractables and leachables" written by Dr Dave Elder, Past-Chairman of the JPAG Committee Download the article
Wednesday 19th February 2020

ICH M9: biopharmaceutics classification system-based biowaivers
Here is another article in the series reproduced with permission from the European Pharmaceutical Review. It is entitled "ICH Q12: "ICH M9: biopharmaceutics classification system-based biowaivers" written by Dr Dave Elder, Past-Chairman of the JPAG Committee Download the article
Monday 6th January 2020

ICH Q12: Technical and regulatory considerations for pharmaceutical pr
Here is another article in the series reproduced with permission from the European Pharmaceutical Review. It is entitled "ICH Q12: Technical and regulatory considerations for pharmaceutical product lifecycle management" written by Dr Dave Elder, Past-Chairman of the JPAG Committee Download the article
Monday 6th January 2020