There are already a series of excellent background pharma eLearning modules which cover all phases into marketing authorisation which we will reference & link to during the content development.
This primer is to encourage people to ‘do’ based on their background knowledge and experience. It also links with ethos of the water sanitation module subject matter experts and how to encourage researchers to develop their capacity and others around them.
- Existing People’s University students who may have some clinical background or an interest in a clinical career.
- Citizens with an idea either for medicine or medical device/technology who may either be ‘tinkering’ in the case of technology or possibly doing some informal research.
- Citizens who are interested in finding out more about routes that medical or tech entrepreneurs might be following in their country.
- Citizens who may have people they know or themselves with a disease and are passionate about finding a cure but have limited access to pharma/tech industries
Outcomes (full outcomes currently under further discussion)
- To start a discussion with relevant partner and/or to take forward an idea into a phase of development that is regulated.
- To identify appropriate future markets for their idea and how to navigate the regulatory practices that may be applicable
- To evaluate risks and prepare safe conditions for the investigation of their idea
Outline (may change completely in the next week and if it doesn’t, not necessarily in this order)
- Taking forward my/our idea
- Is it my/our idea to develop?
- Is my/our idea going to matter / success against a pharma giant like GSK, Pfizer?
- What are the environmental and other conditions affecting my idea (possibly loosely around PESTLE 2.0)
- Innovation ‘case study’ / vignette / scenario
- What are the regulatory and industry environments where my idea will develop
- EU case study / vignette / scenario
- Regulatory information gathering
- Legislation & harmonisation
- Horizon scanning
- How can I/we reduce risk?
- Safety case studies / vignettes / possibly a fun pharma industry archetype
- Environmental health considerations
- How can I / we find partners or identify expertise?
- this may include a link to an outcome of a complementary water sanitation research project that I will know more about shortly but generally capacity building
- How to protect idea
- Markets & Sales (e.g. reference to Dragons Den / Angels investment & pharma/tech)
A reviewer has pointed out that people would be tempted to skip 1-3 as 4 sounds the best way to get going. We may or may not open up 4 until some of 1-3 completed but agreed that if we can’t point out why the groundwork of 1-3 is useful to make the best of 4 then we have essentially failed !
Any comments welcome