The latest publications and conference presentations:

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

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):

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:

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

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):

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

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

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

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:

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

Interview with Anieka Parry, September 2022 in KAUST magazine:

Interview with Nathalia Delgadillo, May 2022 in KAUST magazine:

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

Human Antibody Repertoires eBook, March 2022 in informaconnect:

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:

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

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

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

Interview spotlight, April 2021, in Kolabtree:

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

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

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

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

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

Cortex Couture, September 2020 in Seisma Magazine:

Upon the Stage, September 2020 in Seisma Magazine:

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

Oligonucleotides and peptides_ the regulatory challenges, July 2020  in informaconnect:

Diversity in the Life Sciences Workplace,
June 2020 in informaconnect:

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

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

Manufacturing oligonucleotides: addressing safety and delivery challenges, March 2020 in informaconnect:

Manufacturing Incident Reports (MIR) under the EU MDR, February 2020 in informaconnect:

Preparing you organisation for MDSAP: Australia, Canada, Japan and Brasil, February 2020 in informaconnect:

Article 117: preparing Drug Device Combination product manufacturers for the EU MDR, February 2020 in informaconnect:

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

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

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

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

Regulatory challenges and strategies for oligonucleotide, peptide and mRNA therapeutics, January 2020 in informaconnect:

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

Metabolomics, a go-to approach in Systems Biology, November 2019, in Technology Networks:

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

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

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

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

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

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

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

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

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

Designing Novel Protein Therapeutics & Identifying Appropriate Targets, May 2019, in informaconnect:

Underwater banquet, May 2019, in Countlesssheep:

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

Alcohol or Melatonin, September 2018, in Countlesssheep: