UBC’s Post

📢 FDA update | Drug Development Focus | Benefit-Risk (B/R) Assessment for New Drug and Biological Products, new guideline 🧠 FDA’s benefit-risk assessment is a multi-disciplinary approach considering different aspects: 👉 therapeutic context, condition itself and current standard of care, 👉 evidence, the sponsor’s currently available data, the “strength” of the concept, but also, 👉 uncertanties or risks of the concept, and 👉regulatory options, mitigating these uncertainties the proper way, to enable assessor to get the valid conclusion and make a right decision for the drug candidate in supporting innovative, safe and effective therapy in area of unmet medical needs to reach the patient. 🎯 🛎️ Allocate some time to consult this guideline and learn about the pillars in the pre-market stage with huge registration and post-market impacts: 👉 Planning and proper designing of the product B/R framework, 👉 Leading informal or formal meetings with the FDA, syncronized with the product development plan, 👉 Involving patients and learning from the PPI - patient preference information, and 👉 Continual B/R monitoring during the development for further evidence strengthening. 🎯 🎉 BTW, we got PIND number from CDER the same day we requested it! Stay proactive and continue with timely planning and executing of all pre-IND activities, but be aware of this great update (from practice), too!👍 Happy Monday!✌️ #FDA#INTERACT#PIND#IND#NDA#drugdevelopment#developmentstrategy#newbenefitriskframework#regulatorystrategy#FDAmeetings

Dr. Shridhar Gawade is discussing cutting-edge tools and strategies for detecting DEG and EG impurities. He is delving into practical risk mitigation methods that are transforming the industry at the 2nd Annual Pharma Impurity Conclave 2024. #ebmpic2024 #eminencebusinessmedia #eminencegroupventures

#FDA noted that an #URRA should be considered while creating a risk management framework for a product, should cover the entire human factors engineering process, and may be present in every phase of a medical product’s lifecycle. URRAs should be created early in a product’s development and updated as needed during that product’s lifecycle. #combunationproduct #drugdevive #medicaldevices #HF #HFE #drugdevelopment #DDSs #riskassessment https://lnkd.in/d3rPt2iP

Unlocking the secrets to perfect peptide purity with Gopal Vaidyanathan delegates are exploring how critical thinking and risk assessment are transforming impurity management and mutagenicity at the 2nd Annual Pharma Impurity Conclave 2024. #EminenceBusinessMedia #EBMPIC2024 #EminenceGroupVentures

Ever wondered how much nitrite is actually present in potable and purified water? Not as much as you think is the answer. Check our latest paper for nitrite data in water and what it means for nitrosamines risk assessments.

Have you considered CPCA in your risk assessments? ProPharma can support you in keeping your risk assessments aligned with regulatory and scientific advances in the field. #PharmaResearch

Have you considered CPCA in your risk assessments? ProPharma can support you in keeping your risk assessments aligned with regulatory and scientific advances in the field. #PharmaResearch

Have you considered CPCA in your risk assessments? ProPharma can support you in keeping your risk assessments aligned with regulatory and scientific advances in the field. #PharmaResearch

The risk of a rope breaking is an excellent example of why risks must be analyzed as bad systems rather than as just bad events. A rope breaking is an event. The frequency of a rope breaking is tough to guess for many reasons. However, if the risk is viewed as a potentially bad rope that might break, a great deal of information becomes available about the risk. Is the rope strong enough for the load? Is the rope damaged? Is it being used properly? The rope, e.g., like all risk systems, has a great deal of information with respect to the likelihood of it breaking. Many people will instinctively look at the rope for analyzing the risk, but many others won’t. All risk events come from the risk’s mechanism of action (or system). From financial institutions, people, presidential candidates, security systems, operating processes, etc. are potentially bad risk systems that can produce a myriad of bad consequences or failed objectives. Understand the systems and you understand the risks. Only by critically and objectively analyzing a risk’s mechanisms can you stand a reasonable chance of predicting the likelihood and severity of the events the system could produce. Risk analysis should be about 99% analyzing a risk’s systems. #risk #riskanalysis #riskmangement #ichq9 #iso31000 #fda #qrm #pharmaceuticals #biopharmaceuticals #rera #riskbenefitanalysis #riskbenefit #medicaldevicerisks

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