Independent Senior Consultant in Health Policy, HTA and HEOR and Personal Chair Professor
The Implementing Regulation on Joint Clinical Assessment #HTAR #JCA published by the European Commission on May 23, 2024 contains two important changes when compared with the draft act that was in public consultation in March. #HTA #Europe #MarketAccess #pharmaceuticals
Successful filing of initial IND and IND-LCM submissions. Decode how Freyr succeeded in filing the ad hoc submissions to the FDA and helped the client with their business requirements while maintaining high quality. Download the proven case. https://lnkd.in/gtvyWQPc #Pharmaceuticals #PublishingandSubmissions #INDLCMSubmission #ZeroErrors #FreyrSolutions #ProvenCase
MRG is getting ready for RAPS Convergence 2024! As experts in registration in the MENA region, we’re excited to share our knowledge at this key event. Come visit our booth to share with you how MRG can help navigate regulatory pathways. Stay tuned for more updates as we prepare for a great event. #MRG #RAPS #REGULATORYAFFAIRS #SAUDIREGISTRATION #MDMA #EGYPTMEDICALDEVICES #PHARMACEUTICALS
Time is running out! Have you registered for Freyr’s free webinar on “Overview of PMDA Clinical Trial Consultation”, scheduled for October 15, 2024? Register now to gain an in-depth perspective on the Regulatory expectations and challenges to expand your footprint in Japan. https://lnkd.in/gumnad_G #Japan #MedicinalProducts #Pharmaceuticals #clinicaltrial #Freyr #FreeWebinar #Webinar #RegulatoryAffairs
#PatientEngagement Country Guidelines for #France are now available ⛳️ Discover the Guidelines for country codes of conduct that govern interactions between #Pharmaceuticals & #patient community. Explore now: https://lnkd.in/enXDvzT7
Exciting developments in the FDA's draft guidance on Prescription Drug Use-Related Software (PDURS) have sparked important conversations within the pharmaceutical industry. Our team has been closely following this framework and engaging with stakeholders to stay ahead of the curve. What are your thoughts on the impact of these regulatory considerations? https://ow.ly/vucl50RFUWs #FDA #pharmaceuticals #PDURS #regulatoryaffairs Marty Culjat, Kory Dillman, Scott Kellogg
Successful filing of LCM-grouped Submissions for an IND. Decode how Freyr was able to file valid submissions to the USFDA with zero errors and warnings. Download the proven case. https://lnkd.in/dVJNcnQ5 #Pharmaceuticals #RegulatorySubmissions #LCMGroupedSubmissions #CaseStudy #ZeroErrors
Exciting developments in the FDA's draft guidance on Prescription Drug Use-Related Software (PDURS) have sparked important conversations within the pharmaceutical industry. Our team has been closely following this framework and engaging with stakeholders to stay ahead of the curve. What are your thoughts on the impact of these regulatory considerations? https://ow.ly/vucl50RFUWs #FDA #pharmaceuticals #PDURS #regulatoryaffairs Marty Culjat, Kory Dillman, Scott Kellogg
Are you facing challenges in navigating the complex process of DMF submissions? We offer comprehensive solutions to ensure your Drug Master File submissions meet all FDA requirements by providing a seamless path to expedited approvals. Trust Freyr to handle your DMF complexities, so you can concentrate on advancing your pharmaceutical innovations. https://lnkd.in/gjtPYEAB #PharmaReg #DMFSubmissions #FDACompliance #Pharmaceuticals #FreyrSolutions
Successful filing of LCM-grouped Submissions for an IND. Decode how Freyr was able to file valid submissions to the USFDA with zero errors and warnings. Download the proven case. https://lnkd.in/dVJNcnQ5 #Pharmaceuticals #PublishingandSubmissions #LCMGroupedSubmissions #CaseStudy #ZeroErrors #FreyrSolutions
