Ask Epista Episodes

Welcome to Ask Epista, a video podcast where our experts share knowledge with the Life Science industry in short, 10 minute videos. Our goal is to contribute to a higher level of insight across companies, regulators, and technology suppliers.

With our finger on the industry’s pulse, Ask Epista tackles the issues that are important to Life Science professionals. Episodes are published here, as they become available.

IDMP

IDMP FAQ #1: What is IDMP?

FAQ #2: How can I prepare for IDMP?

IDMP FAQ #3: Should I care about IDMP if I'm not an MAH (Marketing Authorization Holder)?

FAQ 4: Is there potential business value to implement IDMP – beyond compliance?

‍

Serialization

Serialization tips for Life Science companies new to commercialization

‍

Software as a Medical Device (SaMD)

Do you know how to classify your SaMD under the new MDR regulations?  

Good advice and important considerations for SaMD that includes AI or Machine Learning (ML)