Registitute’s Post

Every day we work on drug development can be a day of defeat. Now it has hit the drug Relyvro, which was approved in advance in the USA due to patient pressure - without phase 3 clinical data. Not every indication gets as much attention as ALS with the ICE Bucket Challenge. Nevertheless, every day we experience such results and defeats is always a bad day for us. Especially when it comes to indications that actually have no treatment alternatives. The hours and days that we and other people have put in with and around clinical operations are suddenly useless. It is important to get up again and generate new courage and new strength for further drug developments. Our studies verify a scientific hypotheses. This must not and should not be forgotten in these moments. # clinicalresearch #cranet#

New drugs and clinical trial (NDCT) rules 2019 New drugs and clinical trial (NDCT) rules 2019 -This video focus on the regulation of New Drugs, Investigational New Drugs for human use, Clinical trials, Bioequivalence study, Bioavailability, and Ethics committee. Also on submission of applications and grant of approvals of various categories of new drugs and clinical use. https://lnkd.in/dN7Z8UdT #biotechnology #pharma #pharmacy #microbiology #student #jobsinclinicalresearch #careerinclinicalresearch #clinicalreasearch #clinicalresearchcoordinator #clinicaltrials #clinicalresearchassociate #crc #cra #jobsinclinicalresearch #cro #clinicalresearchorganization #contractresearch #contractresearchorganization #clinicalresearch #ndct #ndctrules2019 #cdsco #regulatory

A significant increase FDA submission with #AI elements, particularly in #ClinicalTrials. It is an interesting meeting with #FDA and #industry of how interaction of #FDA and #industry will shape the drug discovery, manufacturing processes, clinical trials, to support our patients. FDA: Artificial intelligence (AI)1 has the potential to revolutionize health care by advancing medical product2 development, improving patient care, and augmenting the capabilities of health care practitioners. Aligned with its mission of protecting, promoting, and advancing public health, and building on the Agency’s longstanding commitment to support innovative work in the development and regulation of medical products, the Food and Drug Administration’s (FDA’s) Center for Biologics Evaluation and Research (#CBER), Center for Drug Evaluation and Research (#CDER), Center for Devices and Radiological Health (#CDRH), and Office of Combination Products (#OCP) are jointly publishing this paper to provide greater transparency regarding how FDA’s medical product Centers are collaborating to safeguard public health while fostering responsible and ethical innovation. 

#Doyouknow the #COMBINEProject? The COMBINE project was launched in June 2023 to address the challenges stakeholders must address when conducting combined studies in Europe. Combined studies involve combinational clinical activities between #medicines, #invitrodiagnostics and #medicaldevices in all combinations. The operational interface of such activities involves 3 different Regulations, namely the Clinical Trials Regulation #CTR, the Medical Devices Regulation #MDR, and the In-Vitro Diagnostic Medical Devices Regulation #IVDR. In a report published a few days ago, the European Commission, national authorities, #ethicscommittees, the European Medicines Agency and others, have discussed the challenges when conducting combined studies in #Europe and have proposed strategies to streamline the corresponding regulatory ecosystem. The authors highlight the importance to try to align requirements in terms of documentation, timelines and processes where this is possible in order to facilitate #clinicalresearch and #healthcareinnovation #pharma #pharmanews #medtech #medtechnews #biotech #bioechnews

New drugs and clinical trial (NDCT) rules 2019 https://lnkd.in/dm44787v New drugs and clinical trial (NDCT) rules 2019 -This video focus on the regulation of New Drugs, Investigational New Drugs for human use, Clinical trials, Bioequivalence study, Bioavailability, and Ethics committee. Also on submission of applications and grant of approvals of various categories of new drugs and clinical use. #biotechnology #pharma #pharmacy #microbiology #student #jobsinclinicalresearch #careerinclinicalresearch #clinicalreasearch #clinicalresearchcoordinator #clinicaltrials #clinicalresearchassociate #crc #cra #jobsinclinicalresearch #cro #clinicalresearchorganization #contractresearch #contractresearchorganization #clinicalresearch #ndct #ndctrules2019 #cdsco #regulatory

New drugs and clinical trial (NDCT) rules 2019 https://lnkd.in/dm44787v New drugs and clinical trial (NDCT) rules 2019 -This video focus on the regulation of New Drugs, Investigational New Drugs for human use, Clinical trials, Bioequivalence study, Bioavailability, and Ethics committee. Also on submission of applications and grant of approvals of various categories of new drugs and clinical use. #biotechnology #pharma #pharmacy #microbiology #student #jobsinclinicalresearch #careerinclinicalresearch #clinicalreasearch #clinicalresearchcoordinator #clinicaltrials #clinicalresearchassociate #crc #cra #jobsinclinicalresearch #cro #clinicalresearchorganization #contractresearch #contractresearchorganization #clinicalresearch #ndct #ndctrules2019 #cdsco #regulatory

I’m elated to announce that I’ve completed the NPTEL course on "Current Regulatory Requirements for Conducting Clinical Trials in India for Investigational New Drugs/New Drug (Version 3.0)" Through this course, I gained a solid understanding of: 1. The 'New Drugs and Clinical Trials Rules 2019' for conducting trials of new or investigational drugs in India. 2. The 'essential documents' required for conducting and approving clinical trials. 3. The purpose of key guidelines such as 'Good Clinical Practice (GCP)' and the 'National Ethical Guidelines for Biomedical & Health Research' (2017) This knowledge will significantly contribute to my career in clinical research, and I'm excited to put these insights into practice. #NPTEL #ClinicalResearch #DrugDevelopment #RegulatoryAffairs #GCP #EthicsInResearch #SWAYAM

New drugs and clinical trial (NDCT) rules 2019 https://lnkd.in/dN7Z8UdT New drugs and clinical trial (NDCT) rules 2019 -This video focus on the regulation of New Drugs, Investigational New Drugs for human use, Clinical trials, Bioequivalence study, Bioavailability, and Ethics committee. Also on submission of applications and grant of approvals of various categories of new drugs and clinical use. #biotechnology #pharma #pharmacy #microbiology #student #jobsinclinicalresearch #careerinclinicalresearch #clinicalreasearch #clinicalresearchcoordinator #clinicaltrials #clinicalresearchassociate #crc #cra #jobsinclinicalresearch #cro #clinicalresearchorganization #contractresearch #contractresearchorganization #clinicalresearch #ndct #ndctrules2019 #cdsco #regulatory

📝 News for Pharmaceutical Professionals! 📝 The European Medicines Agency (EMA) has released a draft reflection paper on the use of real-world data (RWD) in non-interventional studies to generate real-world evidence (RWE). This paper aims to provide guidance on leveraging RWD for regulatory decision-making in the pharmaceutical industry. 🗓️ Consultation Dates: The consultation period is open from May 3, 2024, to August 31, 2024. This is your opportunity to contribute your insights and expertise to shape the future of RWE utilization in non-interventional studies. 📑 Draft: Consultation Open Reference Number: EMA/CHMP/150527/2024 The use of RWD holds immense potential to complement traditional clinical trial data, offering valuable insights into the real-world effectiveness and safety of medicinal products. By participating in this consultation, you can play a pivotal role in shaping the regulatory landscape and ensuring the robustness and reliability of RWE. Visit the EMA website to access the draft reflection paper and submit your comments. https://lnkd.in/eRnjiBfD Let's work together to harness the power of real-world data for evidence-based decision-making in healthcare! #RealWorldEvidence #Pharmaceuticals #RegulatoryInsights #EMAConsultation

Staying updated with industry trends is key to our success. Recently, our Clinical Pharmacology and Pharmacokinetics team participated in the ISCR - USFDA workshop on 'Regulatory Perspectives in the Design and Execution of BA/BE Studies for Generic Drugs.' The workshop offered valuable insights into human subject protection, data integrity, and integrating digital tools to enhance regulatory practices.  At MSN, we are committed to the continuous development of our employees, ensuring they remain at the forefront of advancement. PADMANABHAN S Shivanand Mohan , SHRM-SCP Abhishek Singh Satyanarayana polapala Dr. Pavan Pradeep T, PhD (Dr.PPT) #continouslearning #learninganddevelopment #learning #regulatory #industryupdates