Volume 28, Issue 3 - Trends in medical writing

Trends in regulatory writing: A brief overview for aspiring medical writers

Author: Surayya Taranum

Abstract

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References

1. European Commission. The ‘Blue Guide’ on the implementation of EU products rules. 2016 [cited 2019 Aug 05]. Available from: https://eur-lex.europa.eu/legalcontent/ EN/TXT/PDF/?uri=CELEX:52 016XC0726(02)&from=BG.
2. MedTech Europe. The European Medical Technology Industry 2019. [cited 2019 August 05. Available from: https://www.medtecheurope.org/wpcontent/ uploads/2019/04/The-European- Medical-Technology-Industry-in-figures- 2019-1.pdf.
3. EUR-Lex. Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices. 1990 [cited2019 August 05]. Available from: https://eur-lex.europa.eu/legalcontent/ EN/TXT/?uri=CELEX%3 A31990L0385.
4. EUR-Lex. Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. 1993 [cited 2019 August 05]. Available from: https://eurlex. europa.eu/LexUriServ/LexUriServ.do? uri=CONSLEG:1993L0042:20071011: EN:PDF.
5. EUR-Lex. Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices. 1998 [cited 2019 August 05]. Available from: https://eur-lex. europa.eu/eli/dir/1998/79/2012-01-11.
6. Frumento C. French breast implants, the Medical Device Regulation, and a theoretical case study. Med Writ. 2017;26(2):39–40.
7. US Food and Drug Administration. Unsafe and ineffective devices approved in the EU that were not approved in the US. Silver Spring, MD: US Food and Drug Administration; 2012 [cited 2019 August 05]. Available from: http://www.elsevierbi.com/~/media/ Supporting%20Documents/The%20Gray %20Sheet/38/20/FDA_ EU_ Devices_ Report.pdf.
8. European Commission. Press release – New EU rules to ensure safety of medical devices. 2017 [cited 2019 August 05]. Available from: http://europa.eu/rapid/press-release_ MEMO-17- 848_en.htm.
9. European Commission. Regulatory framework. [cited 2019 August 05]. Available from: https://ec.europa.eu/ growth/sectors/medical-devices/
10. Eur-Lex. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices. 2017 [cited 2019 August 05]. Available from: https://eur-lex.europa.eu/eli/ reg/2017/745/oj.
11. Eur-Lex. Regulation (EU) 2017/746 of the European Parliament and the Council of 5 April 2017 on in vitro diagnostic medical devices. 2017 [2019 August 05]. Available from: https://eur-lex.europa.eu/legalcontent/ EN/TXT/PDF/?uri=CELEX:32 017R0746&from=EN.
12. Emergo. State of flux: European Notified Body numbers decrease further ahead of MDR, IVDR. 2019 [cited 2019 August 05]. Available from: https://www.emergobyul.com/blog/2019 /07/state-flux-european-notified-bodynumbers- decrease-further-ahead-mdr-ivdr.
13. Mondaq.com. European Union: Update On The Implementation Of The European Medical Devices Regulation And In Vitro Diagnostics Regulation. 2019 [cited 2019 August 05]. Available from: http://www.mondaq.com/unitedstates/x/ 832142/Healthcare/Update+On+The+Im plementation+Of+The+European+Medica l+Devices+Regulation+And+In+Vitro+Di agnostics+Regulation.
14. RAPS. EU MDR/IVDR: US Raises ‘Serious Concerns,’ Urges 3-Year Implementation Delay. 2019 [cited 2019 August 05] Available from: https://www.raps.org/news-andarticles/ news-articles/2019/8/eumdrivdr- us-raises-serious-concerns-urges-3 ?utm_source=MagnetMail&utm_medium =Email%20&utm_campaign=RF%20Toda y%20%7C%202%20August%202019.
15. Vascular News. Europe braces for harder times in medical device innovation while US FDA eases regulations. 2018 [cited 2019 August 05]. Available from: https://vascularnews.com/europe-bracesfor- harder-times-in-medical-deviceinnovation-deviceinnovation- while-us-fda-easesregulations/.
16. Parenteral Drug Association. European Implementation of Medical Device and IVD Regulations - Implications for Australia. 2019 [cited 2019 August 05]. Available from: https://pda.inloop.com/en/ article/123034?id=123034.
17. Martinez-Clark JG. Latin America Offers Welcoming Entry Market Amid Tighter EU Regulations. 2019 [cited 2019 August 05]. Available from: https://www.meddeviceonline.com/doc/ latin-america-offers-welcoming-entrymarket- amid-tighter-eu-regulations-0001.
18. GDPR.EU. Complete guide to GDPR compliance. [cited 2019 August 05]. Available from: https://gdpr.eu/.
19. Thomas KB. Clinical trial disclosure and transparency: Regulation EU No. 536/2014, Public disclosure at the clinical trial level. Med Writ. 2018;27(2):7–17.
20. European Medicines Agency. European Medicines Agency policy on publication of clinical data for medicinal products for human use (EMA Policy 0700). 2019 [cited 2019 August 05]. Available from: https://www.ema.europa.eu/en/document s/other/european-medicines-agencypolicy- publication-clinical-data-medicinalproducts- human-use_en.pdf.
21. Billiones R. Anonymisation reports from 2016 to 2017: A preliminary analysis. Med Writ. 2018;27(2):22–6.
22. Martinsson L. Preparing anonymisation reports in general and for an orphan drug in particular. Med Writ. 2018;27(2):27–30.
23. CB Insights. The clinical trials industry needs a makeover. Here are the technologies looking to shake up the $65B market. 2019 [cited 2019 August 05] Available from: https://www.cbinsights.com/research/ clinical-trials-technologies/.
24. CB Insights. The future of clinical trials: how ai & big tech could make drug development cheaper, faster, & more effective. 2018 [cited 2019 August 05]. Available from: https://www.cbinsights.com/research/ clinical-trials-ai-tech-disruption/
25. Deloitte. Getting real with real-world evidence (RWE). 2018 [2019 August 05]. Available from: http://learn.deloitte.com/ rwe-survey-deloitte-insights.
26. Cynober T. Artificial intelligence in oncology: Fantasy or reality? Labiotech.eu 2019 [cited 2019 August 05]. Available from: https://labiotech.eu/features/ artificial-intelligence-oncology/?utm_ source=twitter&utm_medium=social&ut m_campaign=meetedgar.
27. World Health Organization. Looking at the pharmacovigilance: ensuring the safe use of medicines. [cited 2019 August 05]. Available from: http://apps.who.int/ medicinedocs/pdf/s6164e/s6164e.pdf.
28. Clark R. 62% of Drug Safety Experts Say They’re Using AI to Improve Adverse Event Reporting. 2018 [cited 2019 August 05]. Available from: https://www.copyright. om/blog/drug-safety-using-ai-adverseevent- reporting/.
29. Ventola CS. Big data and pharma - covigilance: Data mining for adverse drug events and interactions. 2018 [cited 2019 August 05]. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5969211/.
30. Brennan Z. Synchrogenix acquires AI-assisted medical writing company ClinGenuity. Outsourcing-pharma 2015 [cited 2019 August 05]. Available from: https://www.outsourcingpharma. com/Article/2015/01/07/Synchr ogenix-acquires-AI-assisted-medicalwriting- company-ClinGenuity.
31. Vincent J. The first AI-generated textbook shows what robot writers are actually good at. The Verge 2019 [cited2019 August 05]. Available from: https://www.theverge. com/2019/4/10/18304558/ai-writingacademic- research-book-springer-natureartificial- intelligence.
32. Chandler DL. Can science writing be automated? MIT News 2019 [cited 2019 August 05]. Available from: http://news.mit.edu/2019/can-sciencewriting- be-automated-ai-0418.
33. Extance A. How AI technology can tame the scientific literature. Nature 2018 [cited 05 August 2019]. Available from: https://www.nature.com/articles/d41586- 018-06617-5.
34. GlobalNewswire. Medical writing market size worth around US$ 3.6 billion by 2026. Acumen Research and Consulting 2019 [cited 2019 August 05] Available from: https://www.globenewswire.com/newsrelease/ 2019/06/11/1867022/0/en/Medi cal-Writing-Market-Size-Worth-Around- US-3-6-bn-by-2026.html.
35. Alechine E, Basu S, Chang C. Cheeky medical writers: Transitioning from academia to medical writing. Med. Writ. 2018; 28(1):20–3.