Hosted by Despina & Ethan at Enkrisi · EN-US · 24 episodes
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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.
Despina & Ethan at Enkrisi hosts The VirtualPharm, a science show with 24 episodes published.
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, includ
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 (
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 d
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 regulato
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 aspec
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 Pharma
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-off
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 stabi
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 contr
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 thor
The podcast discusses the International Council for Harmonisation (ICH) guidelines and their impact on pharmaceutical development. Specifically, the text focuses on the key updates to the ICH guidelines, including Q2(R2)
The International Council for Harmonisation (ICH) has updated its guidelines on quality risk management (QRM) with ICH Q9(R1). This update emphasizes a more proactive and structured approach to risk management in the pha
This Podcast is a guide to authoring a successful CMC Quality Module 3 and Quality Overall Summary (QOS) for a New Drug Application (NDA) submission to the Food and Drug Administration (FDA). Ethan and Desi detail the im
This podcast covers the common regulatory challenges faced by professionals working in the pharmaceutical and biotechnology industries. The authors provide seven scenarios, ranging from an unexpected clinical hold to dif
The podcast episode explores the development of robust stability protocols for Chemistry, Manufacturing, and Controls (CMC) submissions within New Drug Applications (NDA) or Biologics License Applications (BLA). It empha
The episode "Strategic Timing for Defining Regulatory Starting Materials (RSMs)" highlights the impact of timing when defining RSMs during Active Pharmaceutical Ingredient (API) development. It examines three stages—Pre-
The source is a guide to the field of Chemistry, Manufacturing, and Controls (CMC) Regulatory Affairs (RA) within the pharmaceutical industry. It explains the role of CMC RA in ensuring drug development, manufacturing, a
This article argues that strategic outsourcing, particularly for Small Molecule APIs, is a key component of successful drug development . It outlines the benefits of outsourcing for pharmaceutical companies, including co
In this podcast, Desi and Ethan discuss the importance of a robust Global CMC regulatory strategy for pharmaceutical companies seeking global market access. It emphasizes the need to understand the regulatory requirement
This excerpt from "Robust CMC Process for Small Molecules" is a guide to designing robust manufacturing processes in the pharmaceutical industry. It highlights the importance of comprehensive planning, rigorous design, a
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The VirtualPharm is hosted by Despina & Ethan at Enkrisi. The show is categorised under science (chemistry) and has published 24 episodes.
The VirtualPharm has published 24 episodes.
The VirtualPharm regularly covers science, chemistry. It sits in the science category, with a chemistry focus.
The VirtualPharm is accessible for guests with genuine science expertise. A personalised, episode-aware pitch will still outperform a generic one every time.
The VirtualPharm hasn't explicitly signalled guest openness in recent episodes. That doesn't rule out pitching. your hook just needs to be especially compelling and relevant to their recent content.
Episodes of The VirtualPharm average 17 minutes. a focused format where a clear narrative arc and tight preparation matter most.
Our data rates The VirtualPharm's guest bar at 80/100 (Premium tier). Established thought leaders with verified media credentials. Sign in to PitchCentric to see how your own Pod Score compares against this show.
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