Improved electronic submission methodologies - Challenges and future state
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Presentation on our greatest challenge, how current work helps us tackle this challenge and the future
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Improved electronic submission methodologies - Challenges and future state
- 1. Improved electronic submission methodologies Challenges and Future State Ms Emma Richards Assistant Director, Business Systems Review and Reporting Section, Prescription Medicines Authorisation Branch, TGA ARCS Annual Conference 2019 06 AUGUST 2019
- 2. QUESTIONS WHAT IS OUR GREATEST CHALLENGE IN THE ELECTRONIC DOSSIER MANAGEMENT SPACE? HOW ARE WE TACKLING THIS CHALLENGE? Improved electronic submission methodologies 1
- 3. OUTLINE • Define our greatest challenge • Discuss how current work helps us tackle this challenge • Look to the future Improved electronic submission methodologies 2
- 4. GREATEST CHALLENGE WHAT IS OUR GREATEST CHALLENGE IN THE ELECTRONIC DOSSIER MANAGEMENT SPACE? DATA The greatest challenge we have is harnessing our data and presenting it in effective ways. Improved electronic submission methodologies 3
- 5. STATISTICSTotal Number of Sequences Received per Year 0 2000 4000 6000 8000 10000 12000 2017 2018 2019 Received Extrapolated • Number of sequences of data is increasing year on year • In 2019 we are set to reach over 10,000 sequences Improved electronic submission methodologies 4
- 6. GREATEST CHALLENGE To harness our data we need to understand: • WHAT are the data requirements? • HOW will we obtain and analyse the data? • WHY should we do this? Improved electronic submission methodologies 5
- 7. TACKLING THE CHALLENGE WHAT are the data requirements? • IDENTIFY data needs • ASSESS quality and suitability of current data sources Improved electronic submission methodologies 6
- 8. TACKLING THE CHALLENGE HOW will we obtain and analyse the data? PART A: Obtain the data • Delivered in a TIMELY MANNER – Web gateway – Process automation • STRUCTURE and FORMAT suited to analysis – eCTD – Greater use of XML – Specifications (regional and ICH) Improved electronic submission methodologies 7
- 9. STATISTICS 49% 59% 63% 51% 41% 37% 2017 2018 2019* eCTD NeeS * From 1 January 2019 to 24 July 2019 Improved electronic submission methodologies 8
- 10. Today 1/1/2018 1/1/2019 1/1/2020 Minor Variation Safety Related Request Extension of Indications Change to Product Information Extension of Indications Safety Related Request Extension of Indications Safety Related Request Correction Extension of Indications Minor Variation Change to Product Information Extension of Indications Major Variation Minor Variation Notification Self Assessable Request Extension of Indications Extension of Indications Safety Related Request Improved electronic submission methodologies 9
- 11. TACKLING THE CHALLENGE HOW will we obtain and analyse the data? PART B: Analyse the data • TECHNOLOGY – Artificial Intelligence (AI) – Deep Learning – Data visualisation programs • LINKING the data – Determine the appropriate system for the data to be sourced Improved electronic submission methodologies 10
- 12. TACKLING THE CHALLENGE WHY should we do this? Improved electronic submission methodologies 11
- 13. TACKLING THE CHALLENGE Current State Improved electronic submission methodologies 12
- 14. TACKLING THE CHALLENGE Planning Improved electronic submission methodologies 13
- 15. TACKLING THE CHALLENGE Future State Improved electronic submission methodologies 14
- 16. TACKLING THE CHALLENGE WHY should we do this? • To better use available technology • To easily see the full story of each medicine • To assist with evaluations and post-market requirements Improved electronic submission methodologies 15
- 17. TACKLING THE CHALLENGE WHY should we do this? • To BETTER USE available technology • To EASILY SEE the full story of each medicine • To ASSIST with evaluations and post-market requirements Improved electronic submission methodologies 16
- 18. TACKLING THE CHALLENGE WHY should we do this? To draw meaningful insights to assist in ensuring the ongoing safety, efficacy and quality of medicines. Improved electronic submission methodologies 17
- 19. LOOK TO THE FUTURE The Future of electronic submissions in Australia • Utilises emerging technology • Provides enhanced support for decision making • Streamlines dossier processing Improved electronic submission methodologies 18
- 20. LOOK TO THE FUTURE How can you help? • Ask questions, provide suggestions • Feedback on upcoming guidance and specifications • Tidy up – look at transitioning to a single format with lifecycle history Improved electronic submission methodologies 19
- 21. LOOK TO THE FUTURE How can you help? • Plan your future gardens Contact edr@health.gov.au to discuss further. Improved electronic submission methodologies 20
Notas del editor
- I would like to start this presentation with a question. Please consider What is our greatest challenge in the electronic dossier management space? AND How are we tacking this challenge?
- Before we discuss the questions, here is a quick summary / plan of what we will be looking at today.
- Back to the questions. What is our greatest challenge in the electronic dossier management space? The greatest challenge we have is data. Our purpose is to structure and present this data in an effective way – harness the data. Imagine if when we receive an application the evaluator also received a summary of information known about the active ingredient and any similar products, what else we currently have under evaluation and if there are any important post market considerations. For example – the summary may state that you a similar product the s31 questions focuses on issues around liver toxicity and the post market data for products within the same class indicates that head aches are a commonly reported adverse event and this has resulted in a number of PI changes. Could this mean that you get s31 questions faster or would this mean that the evaluation timeframes change? These are unknowns until we try! If time permits - Provide example of how supermarkets use big data via loyalty cards. Utilise article titled Coles, Woolworths and Big Data: Could you choice of cereal affect your insurance premium? The data is available and the tools to analyse this data are also available, so what are the next steps?
- 2017 total sequences = 6850 eCTD = 3407 NeeS = 3443 2018 total sequences = 9591 eCTD = 5636 NeeS = 3955 2019 till 24 July 2019 = 5778 eCTD = 3661 NeeS = 2117 100% of Type A NCEs in eCTD for 2019
- We need to understand the what, how and why Electronic submissions and the eCTD format have given us data in a form that we can analysis and there is so much we can do with it. We just need to understand what we want (what are the data requirements), how we will obtain and analyse the data and important why we should do this.
- How we obtain and analyse the data is critical. Split this section into two parts – part A obtaining the data A standardised format (eCTD), clear and considered specifications and a timely way of receiving the data are critical to being about to harness and use our data.
- 2017 total sequences = 6850 eCTD = 3407 NeeS = 3443 2018 total sequences = 9591 eCTD = 5636 NeeS = 3955 2019 till 24 July 2019 = 5778 eCTD = 3661 NeeS = 2117 100% of Type A NCEs in eCTD for 2019
- Our complexity is increasing, here we see a listing of the changes to one medicine (Pembrolizumab) over the past eighteen months.
- Part B of the how is how do we analyse the data? Choose appropriate tools Source data from appropriate locations (single source of truth)
- To address the why should we do this question I want to step away from talking about electronic submission dossier management systems for a moment and talk about gardening. I am a keen gardener (thought you wouldn’t know it looking at my backyard at the moment!). I was out in the backyard on the weekend preparing the soil for planting Spring seeds and thinking about this presentation and it hit me – gardening is very similar to dossier management systems. There is the obvious lifecycle management connection but there are also many other comparisons that can be made and I would like you to think about these comparisons during the next couple of slides.
- My current garden grows some vegies not enough for me to live off but enough to have home grow vegies for dinner once a fortnight. I haven’t picked the perfect location in the backyard - It doesn’t get full sun and the winter frost is not great. At the moment I am learning via trial and error and am very focused on individually managing every plant but at the same time using a one size fits all method - using the same fertiliser, same amount of water etc. – labour intensive for limited return. Don’t get me wrong I love the little garden but I am not going to win any vege growing competitions.
- The dream is to open the garden up and be able to fed more people, I don’t want the garden to be ‘mine’ I want it to be shared – a community garden with no barriers
- In this future state community garden our goals are clean – to provide vegies for anyone. The garden is monitored (automated), there is an irrigation system, slow release fertiliser where it is required, organised beds that are structured and fed differently depending the plants requirements. The gardeners can focus on focus on planning and introducing new plants with new requirements (growing the garden). Importantly the full potential of the garden is being realised.
- Back to electronic dossier management systems – why do we want a future state where we harness data better?
- Ultimately To make informed decisions and draw meaningful insights to assist in ensuring the ongoing safety, efficacy and quality of medicines being used by Australia's
- We are building a self-sustaining dossier management system so we can focus on using the data to assist with the evaluation process. We are all involved Our roles is to ensure that the data is available and easily accessible (without needing to rummage through the garden) to consider the safety, quality and efficacy of a medicine and make a timely decision.