The latest publications and conference presentations:

MedTech Forum 2024 and its regulatory crystal ball, August 2024 in Journal of Medical Device Regulation: https://globalregulatorypress.com/product/august-2024-volume-21-issue-3/

Randomized Clinical Trials vs Validation Cohort Studies of Artificial Intelligence/Machine-Learning enabled medical devices, May 2024 in RAPS Euroconvergence 2024 (Berlin): https://euroconvergence2024.eventscribe.net

Effective strategies for high-quality clinical data collection through post-market clinical follow-up surveys and medical device registries, in May 2024 in RAPS Euroconvergence 2024 (Berlin): https://euroconvergence2024.eventscribe.net

Long-term Performance and Safety of Princess Volume Plus Lidocaine for Midface Augmentation: The PRIMAvera Clinical Study (medical writer), July 2023 in Aesthetic Surgery Journal, doi: 10.1093/asj/sjad230:

https://academic.oup.com/asj/advance-article/doi/10.1093/asj/sjad230/7223572?login=false

Artificial Intelligence Trustworthiness: a Global Outlook on Regulatory Guidelines, June 2023 in RF Quarterly:

https://www.raps.org/news-and-articles/news-articles?author=7d040fcd-c7fa-4452-a500-931d558784f9

Using Total Product Life Cycle (TPLC) and Good Machine Learning Practice (GMPL) as your lighthouse when navigating blind among Artificial Intelligence Icebergs, May 2023 in RAPS Euroconvergence 2023 (Amsterdam):

https://euroconvergence.eventscribe.net/agenda.asp?startdate=5/11/2023&enddate=5/11/2023&BCF...=

MDR extension deadline: it's set in stone, April 2023 in IFAPP today:

https://ifapp.org/blog/ifapp-today-april-2023-number-33

Clinical Trials 2023: results to look forward, April 2023 in IFAPP today:

https://ifapp.org/blog/ifapp-today-april-2023-number-33

Tips for Clinical Trial Sponsors: Regulation (EU) No 536/2014, March 2023 in IFAPP today:

https://ifapp.org/blog/ifapp-today-march-2023-number-32

CTIS: A Single-Entry Point for EU Clinical Trials, March 2023 in IFAPP today (International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine):

What is a Technical File and what should it contain?, November 2022 in Regulatory Medical Devices BBH:

https://www.buildingbetterhealthcare.com/news/article_page/Medical_devices_What_is_a_technical_file_...

Trends in Downstream Bioprocessing of Biotherapeutics, November 2022 in Bioprocess International:

https://informa.turtl.co/story/trends-in-downstream-bioprocess-development-bioprocess-international-...

Interview with Anieka Parry, September 2022 in KAUST magazine:

https://rsrc.kaust.edu.sa/news/detail/2022/09/04/student-focus-anieka-parry

Interview with Aislinn Dunne, April 2022 in Red Sea Research Center KAUST magazine:

https://rsrc.kaust.edu.sa/news/detail/2022/04/21/student-focus-aislinn-dunne

Human Antibody Repertoires eBook, March 2022 in informaconnect:
https://informaconnect.com/ebook-human-antibody-repertoires/

The Long term impacts of COVID-19 on Clinical Trials, September 2021 in informaconnect:

Demonstrating sufficient clinical evidence under EU MDR eBook, September 2021 in informaconnect:

https://informaconnect.com/implementation-eu-mdr-medtech-series-ebook/

Interview with Silvia Vimercati at the Red Sea Research Center KAUST magazine, September 2021 in Issuu:

https://issuu.com/red_sea_research_center/docs/newsletter_i10_winter-spring_2021

Answers to your medical device technical files questions, September 2021 in Medical News Regulatory Insight:

https://www.medicalplasticsnews.com/medical-plastics-industry-insights/medical-plastics-regulatory-i...

Personalised medicine: neoantigen cancer vaccines, May 2021 in informaconnect:

https://informaconnect.com/personalized-medicine-neoantigen-cancer-vaccines-t-cell-therapy/

Interview spotlight, April 2021, in Kolabtree:

https://www.kolabtree.com/blog/spotlight-interview-with-kolabtree-featured-freelance-scientific-writ...

Clinical Evaluation Report: 5 Tips to Improve Your CER for MDR Compliance, March 2021 in Infomed News: 

https://infomeddnews.com/cer-clinical-evaluation-writing-tips/

Oligonucleotide and Peptide Therapeutics TIDES Europe 2020 post-conference report, December 2020 in informaconnect:

https://informaconnect.com/tides-europe-2020-report/

Oligonucleotide and Peptide Therapeutics TIDES US 2020 post-conference report, November 2020 in informaconnect:

https://informaconnect.com/post-event-report-tides-oligonucleotide-and-peptide-therapeutics/?utm_sou...

EU MDR Approval: Performing the Literature Search, October 2020 in MedTech Intelligence: 

https://www.medtechintelligence.com/column/eu-mdr-approval-performing-the-literature-search/

When to outsource manufacturing? Advice for cell and gene therapy developers, September 2020 in informaconnect:

https://informaconnect.com/outsource-manufacturing-cell-gene-therapies/

Cortex Couture, September 2020 in Seisma Magazine:
https://seismamag.com

Upon the Stage, September 2020 in Seisma Magazine:
https://seismamag.com

Novel analytical strategies and tools for cell and gene therapies, September 2020 in informaconnect:

https://informaconnect.com/novel-analytical-cell-gene-therapies/


Oligonucleotides and peptides_ the regulatory challenges, July 2020  in informaconnect:
https://informaconnect.com/oligonucleotides-peptides-regulatory-challenges/


Diversity in the Life Sciences Workplace, June 2020 in informaconnect:
https://informaconnect.com/diversity-life-sciences-corporate-culture-innovation/


Medical Device Literature Review - expert tips, May 2020 in Kolabtree:

https://www.kolabtree.com/blog/literature-reviews-for-medical-devices-6-expert-tips/


Clinical Trial Patient Engagement - How technology is offering new approaches, April 2020 in informaconnect:

https://informaconnect.com/clinical-trial-patient-engagement-technology-approaches-whitepaper/


Manufacturing oligonucleotides: addressing safety and delivery challenges, March 2020 in informaconnect:
https://informaconnect.com/manufacturing-oligonucleotides-safety-delivery-challenges/


Manufacturing Incident Reports (MIR) under the EU MDR, February 2020 in informaconnect:
https://informaconnect.com/manufacturing-incident-reports-eu-mdr-whitepaper/

Preparing you organisation for MDSAP: Australia, Canada, Japan and Brasil, February 2020 in informaconnect:
https://informaconnect.com/preparing-mdsap-australia-canada-japan-brazil-whitepaper/

Article 117: preparing Drug Device Combination product manufacturers for the EU MDR, February 2020 in informaconnect:
https://informaconnect.com/eu-mdr-article-117-drug-device-combination-products/

Next generation protein drug challenges and and the latest technologies to overcome them, February 2020 in informaconnect:

https://informaconnect.com/protein-drug-challenges-technologies-whitepaper/

EU MDR, new expectations for clinical evaluations and investigations, February 2020 in informaconnect:

https://informaconnect.com/eu-mdr-expectations-whitepaper/

EU MDR: assessing the impact on biocompatibility testing, February 2020 in informaconnect:

https://informaconnect.com/medical-device-regulation-biocompatibility-testing/

Insourcing vs Outsourcing in cell and gene therapy manufacturing, January 2020 in informaconnect:

https://informaconnect.com/insourcing-vs-outsourcing-cell-gene-therapy-manufacturing/

https://informaconnect.com/regulatory-challenges-strategies-oligonucleotide-peptide-mrna/

Novel technologies and approaches for optimising antibody discovery, December 2019, in informaconnect:

https://informaconnect.com/novel-technologies-and-approaches-for-optimizing-antibody-discovery-white...

Metabolomics, a go-to approach in Systems Biology, November 2019, in Technology Networks:
https://www.technologynetworks.com/proteomics/articles/metabolomics-a-go-to-approach-in-systems-biol...

3 Case Studies for implementing wearables in clinical trials, October 2019, in informaconnect:

https://informaconnect.com/wearables-clinical-trials-case-studies/

Clogged Synapses, better call the mailman (or have a shut-eye), November 2019, in Countlesssheep:

https://www.countlesssheep.com/sleep/clogged-synapses-better-call-the-mailman-or-have-a-shut-eye/

Bispecific antibody: ongoing clinical trials, September 2019, in informaconnect:

https://knect365.com/next-generation-therapeutics/article/e0a2599e-9b0d-461c-af7f-1a5935d6b57e/bispe...

https://informaconnect.com/the-emergence-and-benefits-of-bispecific-antibodies/

The emergence and benefits of bispecific antibodies, August 2019 in informaconnect:

https://informaconnect.com/the-emergence-and-benefits-of-bispecific-antibodies/

Major Milestones in Therapeutic Antibody Engineering, August 2019, in Technology Networks:

https://www.technologynetworks.com/biopharma/lists/major-milestones-in-therapeutic-antibody-engineer...

Balance, or "from what are you going to die of, today?", August 2019, in Countlesssheep:

https://www.countlesssheep.com/cool/intriguing/balance-its-all-about-balance/

CMC approaches to accelerate peptide, oligonucleotides, and mRNA therapeutics development, July 2019, in informaconnect:

https://knect365.com/next-generation-therapeutics/article/761c1a11-cd3b-4be8-8848-56ed3a828c3a/cmc-p...

Habenula, the master of the brain, June 2019, in Countlesssheep: 

https://www.countlesssheep.com/cool/habenula-the-master-of-the-brain/

Bispecific antibody engineering and therapeutics, May 2019, in informaconnect:

https://knect365.com/article/pdfs/dd270bd3-fcbd-498b-8cee-cc552f30208b_BispecificAntibodiesWhitepape...

Designing Novel Protein Therapeutics & Identifying Appropriate Targets, May 2019, in informaconnect:
https://informaconnect.com/designing-novel-protein-therapeutics-identifying-targets-whitepaper/

Underwater banquet, May 2019, in Countlesssheep:
https://www.countlesssheep.com/cool/underwater-banquet/

Using Wearables in Clinical Trials, April 2019, in informaconnect: 

https://informaconnect.com/wearables-clinical-trials-beyond-hype-whitepaper/

Alcohol or Melatonin, September 2018, in Countlesssheep:

https://www.countlesssheep.com/cool/alcohol-or-melatonin/