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Here in the UK I have been on "lock-down" and practicing my social distancing along with the rest of the population. This of course means that I have haven't been able to visit clients and future clients as I expected to. Indeed, I was due to fly to US on 30th March, clearly what wasn't possible, and I had instead like the anyone else had to make due with Zoom, Teams, Skype, Gotomeeting, Webex meetings instead. (Why does everyone use a different one – lots of healthy competition in that space!).
So whilst sitting in front of my PC, I thought about what I might be able to do further with my Website (MavenEandL.com). Well, I'm please to say I have now setup a custom E&L forum hosted on my Website for members. Membership is free .😊
What I hope I can do is to encourage a few members and we can together make this a place for active discussion of all things E&L related. I have set up a few channels to get us going and will be granting membership and moderating the content.
The Current Channels are:
Beginner Guide to E&L
Fundamental Leachable Study Design Hints & Tips
Extractable Study Design Hints & Tips
ICH Q3E (what should be included)
Perhaps members can suggest other channels - Mass Spectrum of the month anyone? (a bit experimental?). Not sure about that one but idea might be for members to post a mass spectrum and others help to ID it.
I am also in the process of producing some paid content on the site for those who want it. It will consist of a series of presentations / video content which covers in more depth key topics in E&L. Hope to have that up and running soon.
I was thinking Topics such as:
· Regulatory Expectations for E&L
· Safety Risk Assessment Choices
· Quality by Design for E&L materials
· Risk Management of Leachables
· Complete guide to E&L method development & validation
I also wanted to let people know that about a JPAG meeting which is happening on the 7th May. As you would expect this is a virtual event.
The subject of the meeting is, “ICH Q3E (Extractables and Leachables): setting the scene”.
If you are interested (like me) in the future ICH Q3E I hope this will provide an opportunity to discuss key points and may be influence direction.
I will be providing a talk entitled, “Leachables Studies as an Exercise in Risk Management (Risk Assessment, Risk Control & Review)”. The format of the meeting has been geared towards making the most time for active discussion. Presenters have been asked to pre-record their presentations for review by attendees prior to the event. At the event, the presenters will give a 5 min summary of the presentation followed by a 15 min Q&A of the presentation. This seems to me an excellent format to make the most of the virtual environment and really adds value. Here the agenda:
ICH Process: how to influence (overview of Q3E)
Dr Dave Elder, JPAG/Consultant
Leachables Studies as an Exercise in Risk Management (Risk Assessment, Risk Control & Review)
Jason Creasey, Maven E&L, Consultant
Toxicological safety assessment of E&Ls
Chris Waine, BIBRA
E&L study design: analytical aspects: Similarities and differences in E&L testing for medicinal products and medical devices.
Dr Andrew Feilden, Hall Analytical
Lifecycle management; control strategies for E&Ls?
Dr Carsten Worsøe, Novo Nordisk, Denmark
ELSIE Consortium update: Safety based E&L Limits
Dr Andy Teasdale, AZ
Panel discussion: Opportunities and challenges in shaping ICH Q3E
Hope to see you all there.
Well that is all for this blog entry, I guess it's back to staring out of the window (and a bit of work too!). Hoping you all stay safe and well.