ABOUT THIS PODCAST 🔗
The VirtualPharm Podcast is an audio series that covers topics related to compliance and regulatory affairs in the Lifesciences industry. Each episode, hosted by experts on the topic with decades of experience, offers listeners detailed insight into the changing regulatory environment. The podcast provides timely information about emerging regulations, legal updates, industry insights, and best practices for organizations. The episodes are informative and engaging, helping educate professionals on remaining compliant while staying agile in their industry.
Update frequency:
semiweekly
Average audio length:
17 minutes
Has sponsors
English
United States
24 episodes
since Sept. 26, 2024
episodic
LATEST EPISODE 🔗
This podcast presents ten crucial questions for emerging biotech companies to consider when reviewing their Chemistry, Manufacturing, and Controls (CMC) strategies at year-end. The questions cover various aspects, including regulatory milestones, data analytics, risk management, quality assurance, …
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PREVIOUS EPISODES 🔗
Cracking the Code
CMC Regulatory Compliance in Early Drug Development
Summary
This two-part blog post and podcast series provides a guide for small biotech companies on navigating Chemistry, Manufacturing, and Controls (CMC) regulatory compliance during drug development. It emphasizes the import…
This Podcast offers a structured approach to setting drug specifications when data is limited. It emphasizes a risk-based strategy using industry standards and conservative initial ranges, iteratively tightened as more data becomes available. The process includes focused data collection, regulatory…
This guide explains how to create a high-quality CMC Quality Module 3 and Quality Overall Summary (QOS) for a New Drug Application (NDA) submission to the FDA. It emphasizes the importance of these documents for regulatory compliance, accelerated approval, and demonstrating product quality. The gui…
The podcast explains the complexities of the Regulatory Chemistry, Manufacturing, and Controls (CMC) process in drug development by drawing an analogy to the popular board game Monopoly. The author compares various aspects of the CMC process, like pre-IND planning, formulation development, and regu…
This Podcast discusses the critical role of API process development in the Chemistry, Manufacturing, and Controls (CMC) drug development process. This process focuses on ensuring the drug substance or API (Active Pharmaceutical Ingredient) can be manufactured consistently and safely at scale. The t…
The Podcast focuses on how technology, specifically augmented intelligence (AI), can improve the efficiency and compliance of drug development. The article emphasizes the importance of technology in streamlining back-office operations and supporting the regulatory aspects of Chemistry, Manufacturin…
The podcast provides an overview of drug substance and product stability testing. They describe the importance of stability testing for ensuring product quality and safety. The texts highlight the complexity of FDA stability guidelines, which are intended to provide general principles for conductin…
The provided text focuses on the complexities of regulatory drug development and emphasizes the importance of a comprehensive and dynamic strategy document, particularly in the area of chemistry, manufacturing, and controls (CMC). This document helps streamline the process by providing a visual rep…
The podcast provides guidance on creating a successful Common Technical Document (CTD) application for drug approval, specifically focusing on Quality Module 3. It emphasizes the importance of clarity, accuracy, and thorough documentation in presenting scientific data to regulators. The document hi…
Disclaimer: The podcast and artwork embedded on this page are from Despina & Ethan at Enkrisi , which is the property of its owner and not affiliated with or endorsed by Listen Notes, Inc.
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