Pharma Product Development update

Latest version below – the case studies and EUPATI links will not work unless you have access to the site. If anyone you know wants to review these as well, please contact me to be added (email address required).

It has now been through first major content review from a couple of colleagues, one who is in pharma currently, used to work for MHRA and actively involved in EMA regulatory groups etc and one who is a current pharmacist, educator and previously on the General Pharmaceutical Council in the UK. So it’s passed the “is this a load of rubbish removed from reality” first test. One of the co-founders from People’s Uni has also done a first review and is ok with so far.  A followup test will be with students of People’s Uni who can confirm whether it’s removed from reality from their cirumstances in their countries.  The environmental conditions page has been reviewed and approved by environmental health colleagues who will be writing the water sanitation and environmental health module next year.

3rd & 4th reviewers are pharma colleagues who haven’t been able to review due mainly to Brexit and aftermath of June vote. So I have suggested that we soft launch as is with some of our target audience – previous alumni initially – at end of December and see if 3&4 have had a chance to input by mid January.


Outstanding work (if there were no significant changes from others)

  1. Does my idea matter page – improve it
  2. Liability chart image – needs explanation – this will probably be based around one example of a plant
  3. Networking section – I have 2 colleagues that will be contacting to see if they can input any suggestions.

It is still a huge amount of content and for anyone that has ever visited and run screaming from a drug regulator website for any reason, this is very difficult to avoid but hopefully the scaffolding structure will help make it more manageable. We will know soon enough from our alumni reviewers.

Planning for the environmental health module will begin in mid/late January and will be more straightforward than this module. They have agreed to write the module regardless of obtaining any funds to extend the People’s University work more formally, and there may be opportunities to explore with EurAsian colleagues. I am continuing to learn Russian so hope to be confident with basic conversation in early 2017. I am about to go and start write very basic sentences with simple nouns, verbs and adjectives and will be using part of the Christmas period to continue studying. This will mean I can write emails.

I have also spoken to my colleague who is a co-founder of People’s University and mentioned that on the pharma module we had iterated backwards without involving our target audience from the beginning but we decided that because this has been very informal development, it can still easily iterate once they have begun their review late December. If major changes come in from my external reviewers then because it is a primer and individual Moodle pages, they are relatively easy to move and edit so should hopefully not impact on the subsequent module.



Developing Information Governance for a small political organisation from scratch

After Clive’s campaign had finished in Witney, I offered to help NHA Party with setting up information governance processes for the party. At the time, the Information Commissioners Office had guidance for non-profit organisations in multiple places, but now have an excellent self-assessment toolkit:

There are some areas which are not clear for political parties which I’ll come to later but the link is a great starting place. Confidential information removed from examples below.

Whatever I did needed to be comprehensible for volunteer staff, paid staff and mix of healthcare staff, some of whom would have NHS information governance knowledge / experience, others with none. I have had to write some information governance processes and documentation for learning or online collaboration systems I’ve been involved with and I’ve also been involved in developing Information governance eLearning and working with subject matter experts. It is also expensive to sign off against ISO 9000, 27000 etc and was out of scope at the time.

I started by writing a privacy impact assessment. I informed various members of the Executive of their roles in relation to data protection and party activity, Clive especially was extremely helpful in encouraging this to happen. I contacted each member of staff (voluntary or paid) and did what might be called business process analysis – asking what they did, what they used to do it and where they stored the data. The risks are quite common to different types of organisations.

I contacted each of the technology suppliers used by NHA Party to check how they processed data and I assessed them at the time as ‘adequate’  with a gigantic ‘but’ based on the information they had provided. The ‘but’ was due to the time of the disclosures of NSA illegal data processing and the inadequacy of Safe Harbor (where companies had applied) as indicated through the Max Schrems EU judgement. As EU Data Protection legislation in consultation at the time – for the size of the organisations involved including NHA, I highlighted the risks to the Senior Responsible Officer (SRO – Clive) and  Senior Information Risk Owner (SIRO – Head of NHA IT) and we decided that it would be better to communicate in more detail to members about those risks and continue to investigate model clauses and agreeing information processing agreements (draft example – if I was doing again, it needs updating).

Due to the party’s size and small numbers of staff, rather than create multiple documents, I created an information asset register for the party for all known documents and included the risks and data integrity assessment. I began consultation on a local groups information asset register based on the overall IAR.

The issue that differentiates small political parties from small non-profits is that member documentation is not the same or used for the same purposes – so if you are doing a mailshot for a political party to their own members with different levels of membership, it is not specific in data protection wording / guidance so you have to assume applicability based on any relevant cases from the major political parties which have received public attention.

Before I left the party, I wrote a data breach process draft for consultation and a draft policy because I wanted to leave the party in the best position that I could, even with everything in draft, so that they could make any decisions they needed to make. I also wrote some draft training materials including igtraining. It is different working with volunteers and trying to explain standard IG concepts in a motivating way as another party volunteer myself and I had some difficult conversations that could have gone better.

There was a huge amount of documentation, laws and guidance to read but could do this again in 8 steps:

  1. Complete the ICO Self Assessment toolkit or similar.
  2. Write a privacy impact assessment
  3. Consult with staff / members / Executive about how they currently process information
  4. Update privacy impact assessment
  5. Draft and sign-off information asset register/s
  6. Draft and sign-off data breach process
  7. Draft and sign-off IG / data protection policy
  8. Ensure staff are trained.










Quick win – H5P and Totara / Moodle

We will be creating some videos with assessment questions for staff that are new to the Trust and need to learn different health/hospital IT system applications. They need to be signed off as competent to use after training. We will be screenrecording with narration (inbuilt in Screencast-O-Matic).

H5P is ideal for adding assessment with this, currently in our test site. We did a quick test of functionality using the hub itself by recording a video with Screencast-O-Matic and uploaded then added a couple of questions (v quick, excuse typos).

I set up completion criteria (which is managed by Moodle functionality not Totara so can be used in any Moodle system) so that correct answers report to Moodle gradebook and then a learner is marked as complete. This all worked ok in the test site. We are planning further H5P testing with a migration to the live site in mid January if no tweaks required.

Video / interaction starts 0.11

LMS rules and roles vs operational rules and roles

After informal consultation with different staff groups I have developed a workaround where the learning management system rules and roles do not fit the operational practices of some of our staff groups.

There are different options with open source systems where you could potentially re-code the rules, however in this case I set up the following:

Radiotherapy operational teams are managed by a group of rotating superintendents (not continuously – would be a bit dizzy). So for managers to be aware of or approve course requests, this could involve a huge stream of notification emails going to their inboxes and who wants that!

I created a dummy ID number for 2 group mailboxes which are linked using LDAP – 1 for Chelsea, 1 for Sutton. The superintendents check the group mailboxes when convenient for them and it doesn’t affect reporting because learning completions still recorded against individual unique ids.

I have done the same for the bank staff so that the Temporary Staffing Manager checks when convenient and isn’t flooded.

This would not be so convenient to do in a proprietary system, so far so good.

Inclusive / adaptive martial arts

Have spoken with fantastic instructors this year who are doing amazing work to make different martial arts available to many different needs and abilities.

I have started preparation with my tkd club, this beautifully drawn document is part of a programme I’ve been asked to write based around tkd / sport classifications. Master Mark has asked me to break it down further into military classifications e.g. exercises/activities for tetra/quadriplegia.

After reading part of a Russian journal on physical education and sport tonight, am once again reminded of the huge contribution of Russian physical education to our modern sports and some of my stick ppl exercises/stretches come from generations of those to next generations.

I stand by everything I have said to date, I probably won’t comment again re whatever is in McLaren rpt. As before I really want to see Russia continue to take or extend a leading role in combining pharmacology where appropriate as well as physiology/physical therapy/ed in innovative ways, from their generations of scientific research. 

So others can go running, cartwheeling, somersaulting like I did as a child and I can see in our young students now. Less politics, more fun.

Russia open online course

Is anyone interested in collaborating on this for a 6ish free open online course in 2017.  If others aren’t already doing, am happy to do the behind the scenes admin/development to get it into the public domain.

Please contact me or reply below if it appeals