Regulatory Affairs Professionals Society (RAPS)’s Post

If you are willing to learn more about Venn’s ATMP capabilities then download our latest #factsheet.

Register for our webinar on cDPI development to learn about regulatory and technical challenges in #DPI drug delivery. Gain insights on market understanding, DPI capsule development, and Asian #regulatory frameworks. Join our session led by industry experts from ACG and Vamsi Pharma Private Limited tomorrow - https://lnkd.in/dxktxakb Dr.Jnanadeva Bhat Ravindra Purohit #Makeibetter #dpicapsules #pharma #acgcapsules

The USFDA conducted an online webinar regarding redesigned pre-submission meetings in GDUFA III: Benefits for ANDA Submission and Approval on May 9, 24. From this webinar, I have learned about the following topics relevant to the pre-submission meetings with the FDA for complex generic drug development: #KeyLearning: 👉🏽Review of available pre-ANDA meetings 👉🏽Purpose of redesigned PSUB under GDUFA III 👉🏽PSUB eligibility criteria 👉🏽GDUFA II vs GDUFA III 👉🏽GDUFA III PSUB meeting package 👉🏽New meeting timeline 👉🏽Expectations for day of PSUB meeting #FDA #Webinar #eLearning

FDA is posting Guidance Snapshots In a pilot program, the FDA is posting summaries and key points from its guidance with visuals and in plain language. The webpage has recently been updated with additional snapshot documents. From the webpage: "To support transparent communication and dissemination of FDA guidance documents, FDA is launching the Guidance Snapshot Pilot for a subset of cross-cutting guidance documents on topics that seek to modernize drug clinical trials and accelerate drug development. Guidance Snapshots are a communication tool that provide highlights from guidance documents using visuals and plain language. This pilot program is intended to increase general public awareness and engagement for FDA guidance documents on innovative topics to support the efficient application of the guidance documents’ recommendations." #FDA #guidance #explanation

Guidance Snapshot Did you know FDA has a started a Guidance Snapshot program? FDA guidance documents contain the Agency’s current best thinking on a particular topic. To support transparent communication and dissemination of FDA guidance documents, FDA is launching the Guidance Snapshot Pilot for a subset of cross-cutting guidance documents on topics that seek to modernize drug clinical trials and accelerate drug development. Guidance Snapshots are a communication tool that provide highlights from guidance documents using visuals and plain language. This pilot program is intended to increase general public awareness and engagement for FDA guidance documents on innovative topics to support the efficient application of the guidance documents’ recommendations. #fda #guidance #compliance #gcp #ind #nda

Did you know? New drugs must navigate a complex development process before reaching the market. Along this journey, numerous regulatory challenges must be overcome to ensure patient safety and reliability. 🚨 Register now https://ow.ly/JqIT50TmK8R and learn from our RA expert! #Pharma #RA #Bachem #Webinar #RegulatoryAffairs #Challenges

I am invited to give a workshop to a biotech this Friday. The first time ever, I will challenge myself to discuss RWE guidances and practices from FDA, EMA, CDE and PMDA, in one talk. In my opinion, there are two major breakthroughs that make RWE attractive in drug development, i.e., (1) the advance in RWD and (2) regulatory agency’s flexibility and willingness to consider RWD/RWE. I will focus my presentation on regulatory guidance, infrastructure, demonstrative projects and real examples. Take a deep breath, hopefully I can survive this challenge.

As Japan’s innovative drug pipeline continues to expand, the regulatory measures in clinical trial oversight exhibit distinct characteristics.What are the key features of inspections conducted by #PMDA?How do the focuses of PMDA, #FDA, and #EMA differ in their #regulatory approaches?What best practices should be followed for effective preparation of blinding implementation?How can the effectiveness of blinding procedures be accurately assessed?What key considerations should be taken into account during the inspection process? Join us tomorrow for an exclusive live webinar with SHANHU Co-founder & COO, Jason Sun，on "Practice and Analysis of Blinding in #ClinicalTrials in Japan" Reserve your spot today! https://lnkd.in/g9YPMRzd

Navigating drug development and clinical trials can be challenging, but adhering to strict manufacturing standards is key to avoiding costly FDA delays and ensuring safety. Read the new eBook learn:   ✅ Best practices for each clinical research phase ✅ Ensuring consistency and compliance in drug manufacturing ✅ The role of CMMS in maintaining equipment reliability and data integrity   Equip your team with the tools to streamline clinical research and FDA approval.   Download now to learn more! https://lnkd.in/gKYEkGSy    #Pharma #ClinicalTrials #Manufacturing #CMMS #Compliance #FDA

📺 Watch "Navigating the FDA DHT Guidance: Perspective from Across the Industry" on-demand! View here ▶️ https://hubs.la/Q02Rp4VJ0 The panel started with a review of the FDA guidance that serves as a framework for the development, assessment, and implementation of DHTs in clinical trials, then dove into discussion on key topics including - 🔶 considerations for the multidisciplinary approach to DHT integration 🔶 how the DHT guidance fits into the drug development regulatory landscape 🔶 practical advice and resources for developing verification and validation evidence 🔶 lessons learned and planning for technology advancements #DigitalHealthMonthly #FDAGuidance #DHT #Regulatory #ClinicalTrials