Oisin O'Diomasaigh’s Post

Did you catch Michael Cartwright's session at the PSI 2024 Conference today? Network and ask your questions regarding the pivotal role of Data Monitoring Committees in ensuring the integrity and safety of clinical trials. #ParexelWithHeart #DataScienceInHealthcare #ClinicalTrialsInnovation #PSI2024 #PSIAmsterdam

Meus colegas de trabalho vão a Lisboa! CRB will be at the 2024 ISPE Europe Annual Conference! Visit us at booth 308. You'll also get a chance to hear from Dave DiProspero announce the 2024 Facility of the Year winners, David Estapé discuss a regulatory view on closed systems, and Yvonne Duckworth present improving efficiency and productivity using collaborative platforms. Learn more at the link below. #LifeSciences #Industry40 #ISPE #FOYA

"Two and a half day of intense discussion, presentations, networking and learning we have closed our Annual Members Meeting and the Seminar on Compliance. It was great to see so many engaged colleagues and stakeholders actively participating in the program. Lets keep the momentum going and continue the dialogue - and as mentioned in the closing comment that "Actions" are now key to realize. So let's keep the discussion and collaboration going!!!" Christian-Claus Roth, IPCAA Co-President #ipcaa #healthcarecompliance #healthcareregulations #collaborationopportunity #healthcareconference #pharmaceuticalindustry

Please stop by the booth if you are there and hear about what we can do to assist you in: 1) accelerating your regulatory filings, 2) relieving SMEs of the burden of technical writing (we write INDs, BLAs and NDAs from source documents) and 3) global regulatory strategy. Because we see so many INDs/BLAs/NDAs over the course of a year, we have a unique insight into what the regulatory authorities are focusing on and asking about today. We also do RTF and CRL remediation too but hopefully you will use us first so that remediation isn't needed!

WHO Technical Advisory Group on Biosafety (TAG-B) report of the annual meeting, 26–27 September 2023, Istanbul, Türkiye. Very useful to brainstorm on how to strengthen collaborations and promote biosafety and biosecurity in the Balkan area, the Eastern Mediterranean Region, and worldwide.

A great day today at the TEAM-PRRC summit in Malaga. As a Virtual PRRC it is an opportunity to connect and learn about the challenges and best practices of achieving article 15 compliance. Key takeaways homes from me: The PRRC plays an important role within an IVD manufacturer; to provide a crows nest view of the overall compliance now and in the future. Not one PRRC knows everything, tap into any resource you can to enhance your regulatory intelligence, including your internal teams or external consultants. Make sure the roles and responsibilities of the PRRC is defined, for external providers, be clear on how you interact with your clients and manage expectations. IVDR compliance is achievable if you plan, budget and resource effectively - this be done regardless of scale using plan do check act principles - but don’t underestimate the challenge. The UK equivalent of a PRRC is a welcome addition and will be a key role under UKCA within manufactures and UKRPs If you are not planning implementation of Eidamed yet, start now. Switzerland is in flux, this is an important market so understand the specific Swiss requirements. Phew…. Rest, eat, recover, repeat tomorrow.

Very interesting subject developed by the core group of #ENDCR and #correlationnetwork.

For all of you Colleagues! The DIA Global Forum/June 2024 Issue has many interesting articles including those linking clinical research with regulatory matters such as: 1) The Role of RWD and RWE in Shaping Global Regulatory Practices by Jeffrey Brown, TriNetX, LLC. 2) IDMP and Cross-Border Healthcare: Eliminating Language Barriers (Part 4) by Panagiotis Telonis, EMA; Ta-Jen Chen & Ron Fitzmartin, US FDA; and Julia Nyman & Malin Fladvad, WHO-UMC. 3) The Global IDMP Working Group Focus on a Framework for Global Implementation (Part 5) by Isabel Chicharo & Panagiotis Telonis, EMA; Ta-Jen Chen & Ron Fitzmartin, US FDA; and Malin Fladvad & Olof Lagerlund, WHO-UMC. Thank you to all colleagues and authors listed above as well as other authors who contributed to this DIA Global Forum June 2024 issue. Your contributions and thought leadership makes a difference in our understanding of the topics covered. Interested in writing an article that links clinical research with regulatory matters? Contact me here. It would be a great honor for me to work with you in my capacity of Regulatory Science Editor. https://lnkd.in/gg8gfcMX #FDA #clinicalresearch #clinicaltrials #regulatoryaffairs

#ACR24 - Featured Industry Presentations Many of the great presentations for this meeting come from industry sponsored clinical trials and reports. Often these become the pivotal studies for regulatory approval and the annual congresses are their first look. https://buff.ly/3Ozb5XL

🎉 Excited to share that I have successfully completed the e-Pharmacy Masterclass offered by Hellenic American Union! 🎉 A masterclass full of valuable insights and strategies. #ePharmacy #DigitalHealth #HealthcareInnovation