JoBurmester.com

ICH E6 (R3) – Draft Principles

Published on the 19th April 2021, this document shows that the upcoming revision to ICH GCP will be a complete rewrite of the guideline. This part of the revised document will set out the overarching principles and then there will be two annexes. Annex 1 will cover traditional interventional clinical trials and Annex 2 any additional considerations for non-traditional interventional trials.

Much of the information looks pretty familiar, so in this post I simply want to highlight what I see as the key new points from the Draft Principles document. PLEASE NOTE that this is based on the draft document published at the time of writing and so the final version may be different:

ICH E6 (R3) – Draft Principles Published on the 19th April 2021, this document shows that the upcoming revision to ICH GCP will be a complete rewrite of the guideline. This part of the revised document will set out the overarch…

Today is my last day in the office, so I wanted to wish you all as happy a Christmas as possible, and all the very best for the New Year. Jo x

My latest blog post is a very personal reflection on the last twelve months. I have learned so much this year that I wanted to talk about it with you and I hope provide some support and encouragement as we come to the end of 2020 and begin to look forward to, hopefully a much better 2021.

What have been your key learnings this year?

A Personal Reflection on 2020 I don’t often post about personal stuff, but one of the unusual things in this most unusual of years has been the virtualisation of meetings and the way we have seen into each others lives in a new…

If you are looking for something for your team, we have a free online learning module on Covid-19 and Ongoing Clinical Trials.

The module covers an overview of the key themes in the regulatory guidances issued for those managing ongoing clinical trials in the current Covid-19 situation. There are also links to the guidances and some other resources we have found useful.

The module is available here on our website: https://buff.ly/3b0pDtT

We are beginning to think about next year, and thought it would be a good idea to regroup with a virtual networking event after Christmas, particularly to look at where we are with regards to Brexit.

So please save the date of Monday 25 January 2021 as I will be hosting another online networking event on Hot Topics in Clinical Research!

I think we will all be glad to see the back of 2020, and it would be great to catch up with you in the New Year. I will post details of how to sign up for the event in due course. If you would like to sign up to my mailing list to ensure that you get the full details straight to your inbox please put a note in the comments or drop me a DM.

I nearly missed the fact that JoBurmester.com is two years old already! Thank you so much to those of you who have messaged me, it’s a real encouragement.

This year has obviously been more ”interesting” than year 1, but I’ve found it exciting and challenging to find new ways to work with my clients and appreciate your flexibility and openness to new ideas - as well as your trust in me to keep delivering! I really want to celebrate that things are going well for me, but I am so conscious that many other people have not had the opportunity to grow their business this year. We are starting to see some businesses closing now and it is often the small businesses, which is heart-breaking.

So with Christmas coming up I think we should all try to support our local small businesses as much as possible.

As for me, my amazing husband and I shall be celebrating with with the wonderful Helen Calvert of Clear Day, who has been with me since day 1, and we will raise a glass to the next 2 years.

Medical Devices - new version of ISO14155

The long awaited new version is now available to purchase - I’ve just bought my copy and just need to find time to read it all in detail so I can include in my upcoming webinar.

Key changes are:
— inclusion of a summary section of GCP principles
— reference to registration of the clinical investigation in a publicly accessible database
— inclusion of clinical quality management
— inclusion of risk-based monitoring
— inclusion of statistical considerations
— inclusion of guidance for ethics committees
— reinforcement of risk management throughout the process of a clinical investigation (planning to consideration of results)
— clarification of applicability of the requirements of this document to the different clinical development stages
— inclusion of guidance on clinical investigation audits

I've put a link to the new version, and a link to my upcoming webinar in the comments below 👇

UK Clinical Trial Sponsors with sites in the EU - are you going to be ready for ?

QP(GMP) and Legal Rep BOTH needed in the EU from the end of the transition period!! EC/EMA/HMA joint notice - https://lnkd.in/dPTpFXx

I am today launching my autumn webinar series! You can reserve your place on the events here:

https://lnkd.in/d-5uzDB

I have two webinars scheduled in - one is a GCP Update on Monday 28 September (https://lnkd.in/d2eUmnT) and one is on ISO14155 on Monday 5 October (https://lnkd.in/dHTFpEJ). Both webinars will run from 2pm-4pm GMT.

I look forward to seeing you there!

Celebrating Clinical Trials Day 2020!

It’s interesting to reflect that recognition of the importance of clinical trials has shot up in the current situation. My hope is that the world at large will now understand that clinical trials of new medicines are vital to improving health and well-being for everyone, rather than a tool of the evil pharmaceutical industry to exploit the gullible and vulnerable.

I was recently watching a really enjoyable TV detective series until a few episodes in it became apparent that the culprit was a pharma company “experimenting” on the victims and covering up serious adverse reactions. I couldn’t watch any more. I know there are bad apples in every barrel, but let’s celebrate the good in our industry and clinical trials today, and blow our own trumpets for a change.

Above all my hope is that the current efforts to find vaccines, tests and treatments for Covid-19 will yield results very soon, so we can REALLY celebrate - together!

I am hosting another Hot Topics in Clinical Research networking event on Monday 22 June - this time via Zoom for obvious reasons! The event is free to attend and you can register here:

https://www.eventbrite.co.uk/e/hot-topics-in-clinical-research-tickets-104937761670

We will finalise the topics for discussion nearer the time, but our draft agenda is:

1. Managing clinical trials in a Coronavirus world
Overview of latest regulatory guidance
Discussion of practical implications and experiences

2. Risk Assessment
Overview of requirements and regulators’ expectations
Discussion of experiences and best practice

3. Remote Monitoring and SDV
Summary of regulatory guidance
Discussion of experiences and best practice

If there are additional topics that you would like to see covered please let me know!

Hot Topics in Clinical Research Do you work in Clinical Research? Join us to discuss Hot Topics including managing clinical trials in a Coronavirus world.

So how is everyone doing? It seems as though nearly everyone I speak to uses the words “strange times”, and I’ve use them myself – A LOT! Like most people I have good days and days when I wonder what on earth is going on, but generally I’m hopeful for the future and enjoying spending more time at home.

I’m grateful for a lot of things I’ve taken for granted in the past.

I’m blessed that I can still work and earn a living.

I have family living with me, so I’m not lonely.

I live on the edge of the countryside, so I can walk or run from home every day.

I have plenty of food and toilet roll, and a husband who makes excellent pasta and bread – we’ve even managed to get hold of some flour!

Technology allows me to keep in touch with those I can’t see in person

Work wise I’m glad I can deliver much of my training online, so my biggest challenge is keeping up with the changes to the regulatory guidance documents. It’s good that the EMA, FDA and MHRA keep adding to their guidance, but I get a little frustrated that it’s not always well communicated – it’s hard to keep up to date at the best of times, so I’m grateful for social media and those who post when they become aware of something. On that note, I’ve just done a quick review of the latest new guidance – link in the first comment.

I find myself a little dismayed at the somewhat scattergun approach of the research efforts to find treatments and vaccines – I wish we could somehow have a more coordinated effort, but at least work is being done. I also despair on occasion of the ill-informed opinions touted on social media, one example recently was an OBGYN who obviously doesn’t know the difference between an antiviral and a vaccine, which I find a little worrying!

I guess what I’m trying to say in summary is that there is good and bad in this situation – these things bring out both the worst and the best in people. I’m devastated at the loss of life and all the other costs to life and business, but I’m confident we will come through it in the longer term. We do, though, have some way to go and a lot still to learn.

On a personal level I’m getting through it by baking treats to make us happy, and exercising for my mental and physical health (and so that I can eat more cake)!

Stay safe and feel free to share your own thoughts and strategies in the comments below. Oh, and DON’T believe everything you read online!