CONTENTS
06 09 12
Introducing
Our Committee Members
Plain Language Summaries
By Alexander Jones, Mark Davies, Sinem Castro, and Róisín O’Connor
MedInfo Audit Readiness Checklist
Regulatory Intelligence Updates
As always, feedback from the membership is welcomed and we encourage you to interact with us and the wider PIPA membership via our online platforms below:
Official PIPA Website: https://www.pipaonline.org/
LinkedIn: https://www.linkedin.com/company/pipa-pharmaceutical-information-andpharmacovigilance-association/
We hope to see you online at one of our events in the near future. If there is anything you would like to see PIPA get involved with or do, please do get in touch at pipa@pipaonline.org
We encourage more members to contribute to PIPELINE and make suggestions on topics for articles. Please contact us at journaleditor@pipaonline.org if you would like to contribute or make suggestions for the next edition.
INTRODUCING OUR Committee Members
Over the next few editions of PIPELINE, we will be introducing our current committee members so you can get to know the faces behind PIPA. In this edition, we would like to introduce our new PIPA President, Vice President and Treasurer:
How long have you been a PIPA member? 4 Years
How long have you been in the committee and what made you join?
I joined the PIPA Committee in Dec-2021 with the aim to build on my understanding and experience of Pharmacovigilance through participating in the various workstreams and networking with the amazing people that make up the committee.
Which workstream(s) are you involved in?
I currently hold the position of President as well as Continuing Professional Development (CPD) Workstream Lead. I also actively participate in the PV and Conference Workstreams and QPPV Working Party.
What is a typical day/week/month volunteering as a PIPA committee member?
A typical day as a PIPA Committee member will usually involve collaboration with other committee members through activities such as workstream meetings, guidance reviews and member query resolution. As part of the executive committee, I am also involved in discussions internally and externally around strategy, partnerships, finances, and future projects and generally ensuring that the PIPA organisation runs smoothly. Being a committee member involves a lot of variety because you can join the workstreams that interest you and no day is ever the same.
What inspired you to pursue a career in Pharmacovigilance or Medical Information, and what has been the most rewarding part of your journey so far?
Having left university with a Marketing degree, I found myself joining a Pharmacovigilance department of a global pharmaceutical company because I needed money and they were willing to pay me! However, I quickly fell in love with Pharmacovigilance which led me to return to university and complete a BSc (Hons) in Life Science that has allowed me to progress to where I am today.
What advice would you give to someone starting a career in Pharmacovigilance or Medical Information?
Grab every opportunity to learn something new because the Pharmaceutical landscape is constantly evolving.
Chris Isaacs President
INTRODUCING OUR Committee Members
How long have you been a PIPA member? 4 years.
How long have you been in the committee and what made you join?
I have been on the PIPA committee for over 3 years; for the last 4 months, I’ve been acting as the Vice President. I joined because I wanted to contribute to the advancement of medical information and support my peers through sharing knowledge and best practices.
Which workstream(s) are you involved in?
I’m involved in the Medical Information (MI), Conference, and Training Workstreams.
In the MI workstream, we focus on discussing current challenges and innovations in the MI field; developing MI guidance documents and other resources to facilitate learning and ensure good practice; and last but not the least liaising and collaborating with selected organisations such as UK Medicines Information (UKMi).
In the Conference Workstream, our main goal is to plan the annual PIPA conference by coming up with hot conference topics, and promoting and enhancing knowledge in the fields of pharmacovigilance, medical information and Code compliance by learning from industry experts.
Finally, in the Training Workstream, we develop up-to-date topical online, virtual and face-to-face training courses to provide a platform for continuous professional development.
What is a typical day/week/month volunteering as a PIPA committee member?
A typical month involves attending regular meetings, participating in workstream projects, and contributing to organising events or webinars. Additionally, as the VP, I, along with the President, engage in strategic decision-making, drive initiatives to take the organisation forward, and address current challenges. We also work on developing new resources for our members to ensure the continued growth and success of PIPA.
What inspired you to pursue a career in Pharmacovigilance or Medical Information, and what has been the most rewarding part of your journey so far?
I was inspired to pursue a career in medical information because of my passion for life sciences and my commitment to excellent customer service. I am driven by the goal of encouraging the safe use of medicines and ensuring patient safety. The most rewarding part of my journey has been seeing the direct impact of our work on improving patient outcomes and contributing to public health.
Sinem Castro Vice President
What advice would you give to someone starting a career in Pharmacovigilance or Medical Information?
Having a high attention to detail is essential in Medical Information. This field requires meticulous documentation and thorough analysis to ensure the accuracy and reliability of data. Being detail-oriented helps in identifying potential safety issues and ensuring that all Code compliance requirements are met.
My advice would be to stay curious and continuously seek learning opportunities. Building a strong network within the industry is also crucial. Always prioritise patient safety and ethical practices in your work.
INTRODUCING OUR Committee Members
How long have you been a PIPA member? 4 years
How long have you been in the committee and what made you join?
I moved companies into a new role and wanted to expand my PV network.
Which workstream(s) are you involved in?
I have just taken on the role of treasurer but I also sit on the PV Compliance and MI Workstreams. Previously I have led the PV Training Working Party.
What is a typical day/week/month volunteering as a PIPA committee member?
It can vary from attending a workstream meeting to discuss activities e.g. planning our next conference, answering questions from members, reviewing training courses prepared by the Training workstream, or updating PIPA guidance documents to reflect new legislation updates. Once a month we have a short online committee meeting and then once a quarter we all get together for a full day face to face meeting.
What inspired you to pursue a career in Pharmacovigilance or Medical Information, and what has been the most rewarding part of your journey so far?
I fell into PV by accident looking for a job after University and 20 years later I’m still here. I’ve had various roles over the years from operational work, project management, client management, PV Auditing and I now look after both Pharmacovigilance and Medical Information at Affiliate level. I love getting to work cross functionally with all areas of the business, and I love that no two days are the same. The most rewarding part of my job is when we have audit or inspection and come out with outstanding results. I’m also a line manager and find it rewarding when I can support one of my team to reach their goals within their personal development plans.
What advice would you give to someone starting a career in Pharmacovigilance or Medical Information?
Create a development plan and ensure you share this with your manager and make it part of regular discussions. And if you are not a member already, join PIPA!
Stephanie Bettesworth Treasurer
PLAIN LANGUAGE SUMMARIES:
AN UNDER-USED TOOL TO IMPROVE READER COMPREHENSION WHEN COMMUNICATING SCIENTIFIC INFORMATION
Scientific publications are often written in a manner that makes them less accessible for patients, for example using complex language. Professional organisations have recommended that readily understandable and accessible information should be provided to improve health literacy and help patients self-manage their conditions. One tool to remedy this is to provide plain language summaries (PLSs) of published research. A PLS is a short summary of a scientific publication that is written in a simplified manner. Making PLSs available for more research should improve patient understanding and support their self-management and treatment.
Patients need access to scientific information concerning diseases and treatments to manage their own conditions better in collaboration with healthcare professionals.1, 2 As part of this, it is important that they understand how their treatment works and which issues to be alert for.1, 2
However, research suggests that the scientific information typically available to patients does not use accessible language and is often complex.3, 4 This can cause confusion about optimal disease management and access to appropriate health services, ultimately increasing health inequality.5 Furthermore, non-specialist healthcare professionals may find it challenging to understand specialist publications. Finally, publications misconstrued by journalists and the online community could result in the science being poorly
communicated, with a risk of exaggerated findings and overstated outcomes.
Consequently, professional organisations have recommended that readily understandable and accessible information should be provided,2 with the objective of increasing health literacy. Visuals can be used to explain concepts and to enhance understanding and facilitate presentation of numerical information, and jargon should be avoided. This is typically considered the responsibility of healthcare professionals or the healthcare system; however, the pharmaceutical industry can play an important role in communicating its findings in simplified and easily understood formats, including as PLSs.
WHAT IS A PLAIN LANGUAGE SUMMARY?
A PLS is a short summary of a scientific publication that typically describes research results, and is written in a simplified manner (using plain language) for a broad audience in a way that is easy to read and understand.7, 8 It may also provide context for research that is specific to the patient or caregiver—considered the primary target audience for these materials.5 The enhanced clarity of these publications, designed specifically with the patient in mind, is the defining feature of a PLS since it improves patients’ health literacy and outcomes.9, 10
A PLS is typically published alongside the original article. Infographics, video summaries and podcasts may also be provided to communicate the research to the public.
WHAT IS PLAIN LANGUAGE?
Plain language is suitable for the general public and is meant to be easy to understand, regardless of familiarity with a given topic.5 When drafting a PLS, authors should decide on an appropriate reading age and literacy level, based on the intended audience. The European Union (EU) Clinical Trials Regulation (CTR) on drafting patient lay summaries (Table 1) recommends a reading level of 12 years (US Grades 6–7) and above, and for most PLSs, this is a suitable target.
Other guidance for writing in plain language includes:11, 12
• Avoiding uncommon words, abbreviations and jargon. If technical terms must be included, they should be carefully explained (Table 2)
• Using short sentences
• Using active verbs and an active voice
• Using headings or bullet lists to divide up content and provide structure
HOW TO EVALUATE PLAIN LANGUAGE?
Plain language can be assessed using tools within writing programmes that evaluate readability, such as the Flesch–Kincaid Grade Level formula or the Flesch reading ease test (Table 3) 13, 14 However, these readability formulae were not developed specifically for medical communication purposes, rather for general education. Furthermore, they do not consider meaning or how useful the content is for the reader. Therefore, user testing via patient (the target audience) review is advised when drafting a PLS to support author experience; this approach is informative as it ensures that their needs are met.
ARE WE DOING ENOUGH?
A survey of 22 patient organisations found that all of them considered PLSs to be essential/valuable to patients; with a suggestion that a PLS should accompany every medical publication.9 Despite their usefulness and value, PLSs are not routinely produced for every scientific publication, and they are not easily found online as there is no database detailing their publication. Instead, it is necessary to navigate to the original paper and see if a PLS accompanies it. This suggests that there is an important gap where patient health literacy could be improved.
One suggested approach for increasing the availability of PLSs is to partially automate their development using generative AI tools to create initial summaries for authors to review, edit and enhance. This could speed up their development and reduce the number of person-hours involved. This will be discussed in greater depth in our next article.
References
1. Fleary SA, Joseph P, Pappagianopoulos JE. Adolescent health literacy and health behaviors: a systematic review. J Adolesc. 2018;62:116-27.
2. Hersh L, Salzman B, Snyderman D. Health literacy in primary care practice. Am Fam Physician. 2015;92(2):118-24.
3. Rowlands G, Protheroe J, Winkley J, Richardson M, Seed PT, Rudd R. A mismatch between population health literacy and the complexity of health information: an observational study. Br J Gen Pract. 2015;65(635):e379-86.
4. van der Gaag M, Heijmans M, Spoiala C, Rademakers J. The importance of health literacy for self-management: a scoping review of reviews. Chronic Illn. 2022;18(2):234-54.
5. Riganti P, McKinnon AM. Plain language summaries: enhancing patient-centred care and improving accessibility of health research. BMJ Evid Based Med. 2023;28(5):299-302.
6. Brownell SE, Price JV, Steinman L. Science communication to the general public: why we need to teach undergraduate and graduate students this skill as part of their formal scientific training. J Undergrad Neurosci Educ. 2013;12(1):e6-e10.
7. Plain English Campaign. How to write in plain English. https://www.plainenglish.co.uk/how-towrite-in-plain-english.html. Accessed: 30 July 2024.
8. Dormer L, Schindler T, Williams LA, Lobban D, Khawaja S, Hunn A, et al. A practical ‘how-to’ guide to plain language summaries (PLS) of peer-reviewed scientific publications: results of a multi-stakeholder initiative utilizing co-creation methodology. Res Involv Engage. 2022;8(1):23.
9. van den Broek R, Crowley P, Ellenberger C, Port JLF, Rouwette T, Choudhary S, et al. Key insights from patient organizations for developing effective plain language summaries of medical publications. https://ismpp22.excerptamedica.com/lang/excerptamedica_ismpp22_lang_poster. pdf#:~:text=Patient%20organizations%20suggest%20how%20we%20can. Accessed: 20 July 2024.
10.Mills A. Improving health literacy to support better health outcomes. https://www.nursingtimes. net/clinical-archive/public-health-clinical-archive/improving-health-literacy-to-support-betterhealth-outcomes-08-01-2024/#:~:text=People%20with%20low%20health%20literacy%20are. Accessed: 20 July 2024.
11.Research NIfHaC. Plain English summaries. https://www.nihr.ac.uk/documents/plain-englishsummaries/27363. Accessed: 30 July 2024.
12.Stoll M, Kerwer M, Lieb K, Chasiotis A. Plain language summaries: a systematic review of theory, guidelines and empirical research. PLoS One. 2022;17(6):e0268789.
13.Microsoft. Get your document’s readability and level statistics. https://support.microsoft.com/ en-us/office/get-your-document-s-readability-and-level-statistics-85b4969e-e80a-4777-8dd3f7fc3c8b3fd2. Accessed: 7 August 2024.
14.Kincaid JP, Fishburne Jr. RP, Rogers RL, Chissom BS. Derivation of new readability formulas (Automated Readability Index, Fog Count and Flesch Reading Ease Formula) for Navy enlisted personnel. 1975. https://apps.dtic.mil/sti/citations/tr/ADA006655. Accessed: 20 July 2024.
Alexander Jones Principal Medical Writer Springer Healthcare
Co-authors: Mark Davies, Sinem Castro, Róisín O’Connor For further information, please contact Alexander Jones at
Table 1. What is the difference between a plain language summary and a patient lay summary?
The EU CTR 536/2014 includes a requirement for the submission of a patient lay summary for every clinical trial alongside other regulatory documentation posted online. The lay summaries are written in plain language to enable the public to access and understand the results, and they should be submitted to the EU database within 6–12 months of trial completion. Compared with PLSs, lay summaries are typically larger documents that provide all the required information.
Table 2. Defining important words
When drafting a PLS, scientific terms can be included to assist the patient when discussing the materials with healthcare professionals. It is important that these are defined clearly to enable understanding, and if a lay term is used to improve understanding, the scientific term should also be provided as part of the definition.
Definitions for terms used in this article
AI: Artificial intelligence (AI) is the use of machines, typically computers, that simulate human intelligence processes and perform tasks that typically require human intelligence, such as learning, reasoning and problem-solving
Generative AI: Generative AI is a type of AI that can create new content, such as text, images or music, based on patterns and data that it has learnt according to probability
Health inequality: Health inequality refers to unfair and avoidable differences in health and access to healthcare services experienced by different groups within a population due to social, economic and environmental factors
Health literacy: Health literacy is the ability to find, understand, evaluate and use health information to make informed decisions about one’s health
Infographic: An infographic is a visual representation of information or data, designed to make complex information instantly understandable, through a combination of images, charts and minimal text in a simple and accessible way
Jargon: Jargon is a set of specialised terms used by a particular group or profession—often confusing to those who are unfamiliar with the field
Podcast: A podcast is an audio presentation that can be downloaded or steamed from the internet
Readability: Readability is the ease with which a reader can understand a written text, and it is influenced by factors such as diction, sentence structure and layout
Video summary: A video summary is a brief overview that highlights the main points and key details of a document or presentation in a video format, with the objective of making it easy to understand the content quickly
Visual abstract: A visual abstract is a short video that summarises the main points and findings of a research paper to make it accessible and engaging
Flesch-Kincaid grade level formula
This is a formula that presents a score as a US grade level. It is calculated as follows:
Flesch reading ease test 14
This is a formula that provides a score between 0 and 100; higher scores indicate enhanced readability:
Table 3. Tools within writing programmes that evaluate readability13, 14
MedInfo Audit Readiness Checklist
PIPA’s audit and inspection readiness checklist was designed to help medical information departments identify key points to focus on during the preparation for an inspection. We are delighted to publish the recently updated version, which is also available to download via the PIPA website: https://pipaonline.org/medical-information/inspection-checklist/
Process
Do your medical information (MI) processes align with global and regional documentation? Can you describe each step?
Do you have a process and procedure for the identification and reporting of adverse events (AEs) and product quality complaints (PQCs)? Are staff trained in AE/PQC identification?
How do you access up-to-date relevant product information (e.g. SmPC, PIL)?
Do you have a process and procedure for responding to AEs and PQCs? If MI standard responses are used to respond to enquiries that involve an AE or PQC, are they up-to-date and how are they managed? If the MI standard responses that involve an AE or PQC contain information from the published literature, how is this determined and approved for circulation? If ad-hoc responses are allowed, are these quality reviewed?
Do you have a process in place for reconciliation of AEs/PQCs, reported by MI? If your medical information database is interfaced with the PV or the Quality database, are there regular checks to ensure the systems are exchanging the relevant information such as MI details needed for the AE report, and the AE report tracking number for MI to add to the case in the MI enquiry system?
Can you retrieve all up-to-date MI applicable standard operating procedures (SOPs)/working practices (WPs) and any relevant documented local business processes (e.g. SOPs, WPs describing company requirements and processes followed by MI staff to report AEs/PQCs, to comply with copyright, data protection etc.)?
Is your MI department responsible for product packaging or package insert artwork review and/or approval and if so is there a procedure for the review and approval process?
Process Details
Do you have a local policy/regulatory requirement for retaining hard copy source documents? If so, have you ensured that your archiving procedure is clear?
If you are taking paper notes prior to logging into the MI database or paper notes form part of your MI business continuity, is the scanning and attaching of these documents part of your processes/procedures?
Do you provide an out-of-hours service? If so, do you have a process flow chart or documentation to support this service? Is testing of the service performed and adequately documented? If you do not provide an out-of-hours service, do you have a process to ensure AEs and PQCs are handled/processed in the required timeframe (if reported) (e.g. left on voicemail after business hours, during a holiday shutdown, system outage)?
Are you a global company that handles multiple languages and how is this managed? How are translations handled and is this documented within your procedures?
Do you have a current disaster recovery/business continuity plan for PV that includes MI and covers your MI processes, as appropriate?
What type of back up do you have for your department to show continuous daily business hour coverage (i.e. to ensure AEs and PQCs are handled/processed in the required timeframe)?
Process Roles
Does a job description exist for all positions in MI (contract or permanent)? The job description should describe all key activities of the current role.
Training
Can you provide the role based curriculum for MI in your country/location if asked?
Are training records for MI staff complete?
Are all MI staff trained yearly in AE/PQC identification and is there an effectiveness check for the training?
Do you have an onboarding/training program for new MI staff? Is this documented?
Are the onboarding/training materials (slide decks etc.) for MI staff easily retrievable?
Do you have evidence of MI role-specific training that MI professionals need to undertake regularly to perform their role, e.g. ABPI Code and other pharmaceutical regulations; internal annual AE reporting training; product and disease state training; miscellaneous annual training etc.?
For training completed outside of the training system (e.g. external courses, training at conferences etc.), have you added these to your training system and do they show in your electronic training transcript? If not, do you have documentation (e.g. training roster[s]) as a record of the training?
For other types of training that you provide (e.g. sales representatives, external business partners [e.g. call centre agents] etc.), do you have retrievable training materials and training rosters?
Personnel
Is an up-to-date CV available for all MI staff (permanent and contract, including all call centre staff [if any])? Are CV(s) easily retrievable if requested? (Note: CVs for contract staff may be held by the supplier/vendor but should be readily available on request). Are CV(s) updated, signed and dated on an annual basis?
Does the CV align with the job description i.e. do the skills and qualifications of the personnel in the role (this includes past employees) match with those required to perform the job?
Do you have an up-to-date organisational chart?
Contracts
Do you have service contracts for outsourced MI service providers (if any)? Are these contracts easily retrievable? Do these contracts depict clear procedures for the handling of AE/PQC reports by these partners?
If applicable, do you have Key Performance Indicators (KPIs) for your MI Service Provider and do you monitor the services provided? Are you performing checks on their out-of-hours services?
If applicable, have you audited your MI service provider. If so, are any Corrective and Preventive Actions (CAPAs) for the audit addressed?
Monitoring
Can you describe the quality monitoring program for your database/system? Do you know who to contact globally if questions outside of your scope are asked?
Do you have a process for monitoring the quality of MI responses provided by outsourced MI service providers? If so, is this process documented? Can you show evidence (documentation) that this is conducted on a regular basis?
Do you have a documented approval/withdrawal process for non-promotional materials that the medical information team are responsible for creating/updating/disseminating e.g. scientific decks for Medical Scientific Liaisons (MSLs)? Do you perform spot checks on random job bags/materials to check for compliance with the process?
If you are involved in the provision of risk minimisation materials, do you have a monitoring process in place to ensure that these are sent in line with the specific product’s risk minimisation plan?
Regulations
Can you show how you document off-label MI requests (if required) and/or off-label patient exposure? Can you describe how you determine if patient exposure is off-label?
Can you show how you comply with data privacy and copyright regulations applicable to your country/location?
Inspection
For your department/location, have you assigned the appropriate inspection designee(s)? (Departments/locations may have one or more personnel designated as the point-of-contact for inspections).
Have all MI staff received inspection readiness training? And is this documented?
Are you aware of any previous audit/inspection findings impacting MI? Are they resolved? If they are not resolved, can you explain the status of those findings?
MI Databases
Are you able to easily retrieve MI enquiry data (e.g. in an excel report format) from your MI database?
Is your electronic system for MI validated and, if so, do you have validation documents and the procedure for validation to hand?
Can you run an MI enquiry report from within your system, or do you have to request this via your MI outsourced vendor?
If using an outsourced vendor, do they use your MI system? If so, do you regularly train them on updates to the system?
What is the process for informing the MI teams and keeping them up-to-date with training and any new releases of the MI system(s)?
If your outsourced provider uses their MI system, do you have access to the system to perform quality checks?
What procedure do you have in place in case the outsourced vendor has a system outage?
If you are changing MI systems, have you ensured that you have considered how to access legacy MI enquiries? (For example, via a report that is saved internally, or via an offline version of the decommissioned system, or by migrating the enquiry data into the new system.)
Are appropriate security measures in place so only the correct people are able to access and view enquiries and enquiry responses?
Do you run regular system tests to ensure everything is working correctly?
If your MI team is global, are appropriate local data protection rules followed? Do you have appropriate data retention and data privacy policies in place?
Do you have a process document that explains who has access to the database and why?
MI Telephone Lines and Calls
Do you use a local rate/freephone medical information phone number? If you use an 0845 or other business rate phone number, have you considered the potential implications of this to patient safety due to the potential call charges?
Do you have ownership of the medical information phone number or is it owned by a third party/outsourced vendor? What contracts do you have in place around this?
Do you or the Quality department regularly check the status of the medical information phone line and perform test calls? Are the line checks and test calls logged in an accessible place, if asked for evidence?
If you change the telephone number, have you conducted an impact assessment to work out where the number appears and what materials/assets need to be updated - including digital assets such as websites as well as product packaging/labelling?
What are your business continuity procedures if there is a phone line outage?
Do you perform regular quality checks of calls handled by the MI team (if calls are recorded)?
In our final PIPELINE edition for 2024, we
highlight some of
the recent regulatory intelligence updates affecting pharmacovigilance and medical information
• In August 2024, the Medicines and Healthcare products Regulatory Agency (MHRA) released guidance on ‘Pharmacovigilance following agreement of the Windsor Framework’. From 1 January 2025, the Windsor Framework comes into effect and will mean that all medicines in the UK will be licensed by the MHRA. A collection of documents that provide guidance on the implementation of the Windsor Framework agreement can be found here: MHRA Windsor Framework Hub - GOV.UK
• In August 2024, the European Medicines Agency (EMA) published revision 5 of Annex I – Definitions, revision 3 of the GVP module XVI on Risk Minimisation Measures (RMMs) and its Addendum on the methods for evaluating the effectiveness of RMMs. For details on the publications, head over to the EMA GVP website: Good pharmacovigilance practices (GVP) | European Medicines Agency (EMA)
• In October 2024, the EMA published the Annual Report of the Pharmacovigilance Inspectors Working Group (PhV IWG) for 2023. The three most common areas with findings included the Quality Management System (QMS), the Management and Reporting of ADRs and the PSMF. The annual reports can be accessed from: Pharmacovigilance Inspectors Working Group | European Medicines Agency (EMA)
• In October 2024, the Prescription Medicines Code of Practice Authority (PMCPA) updated their Social Media Guidance. Link to the guidance: PMCPA Social Media Guidance
• In November 2024, the PMCPA published Windsor Framework – PMCPA guidance for promotional material. Link to the guidance: Windsor Framework
• In December 2024, the MHRA published a revised Roadmap towards the future regulatory framework for medical devices. This provides a further update on the intended timelines to implement the future medical device regulations.
◊ Standard: Implementation of the future regulations: https://www.gov.uk/governme nt/publications/ implementation-of-the-future-regulation-of-medicaldevices#full-publication-update-history
• Medical Devices Regulatory Reform - Roadmap to implementation: Med_Tech_Regulatory_Roadmap_V2_ December_2024.pdf
