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Ask Epista

Knowledge to help you turn compliance challenges into business opportunities.

Welcome to Ask Epista, a video podcast where our team of experts share Life Science industry knowledge, in short videos. We are dedicated to continuously improving compliance and business. This way, we believe we can help increase the contribution of Life Science to society.

Ask Epista tackles topics that help Life Science professionals drive innovations that improve health care around the world, today. Here’s a look at Season 1. Click on the boxes below (or just scroll down), to learn more about each episode.

IDMP

IDMP is substantially more complex than the current xEVMPD legislation. And deadlines are quickly approaching, meaning the time to prepare for the complex compliance mandate is flying by. We’ve gathered expert advice to take you from basic understanding to creating business value with your efforts.

Join these episodes on IDMP topics:

FAQ 1: What is IDMP?

This episode introduces IDMP (Identification of Medicinal Products) to those new to the topic. We’ll provide you with context, definitions, and examples of IDMP use cases. The goal is to help you better understand how IDMP could impact your Life Science company.

FAQ 2: How can I prepare for IDMP? - With MAIN5

MAHs with products on the market in the European Union will be the first to use IDMP to communicate information about their products to the EMA (European Medicines Agency). Over the next few years, the EMA will roll out their first iteration of IDMP via their master data initiative, SPOR. In this video we ask MAIN5, our valued collaboration partner, how MAHs can best prepare for the changes that are coming and how to secure continuously improving compliance and business going forward.

About MAIN5: Founded in Frankfurt/Main in 2013, MAIN5 is a Germany-based consulting firm, primarily servicing global Top 50 organizations, with the ability to operate virtually anywhere in the world. Their 30+ consultants have a profound knowledge of the industry and specialize in designing and implementing initiatives of strategic relevance in Life Sciences. In addition to bringing perspective and experience, MAIN5’s team remains constantly flexible. This means that their clients are served by an agile, highly responsive network that can be drawn on this network to create the team with the perfect fit for the job. To learn more about MAIN5, visit their website here

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

This episode sets the coming European Medicines Agency IDMP requirements aside. Instead, we’ll focus on the impact that IDMP will bring to the collaboration partners of MAHs, and our recommended actions for them. This episode is designed for suppliers of drug products and related materials, and drug development companies. Watch to learn how you can best prepare for the changes that IDMP will bring to your collaboration with MAHs - and the opportunities for improvement that you’ll find, as well.

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

The MAH is obliged to comply with the health authorities’ IDMP requirements. But is that all there is to it? Can IDMP potentially support and provide direction for strategic business development? In this video, we discuss how IDMP can drive harmonization and alignment strategies.

Watch the episodes

Serialization

Serialization tips for Life Science companies new to commercialization

You have a lot of knowledge when it comes to raising money, drug development, and go-to-market strategies, but what about commercialization – specifically serialization? In this episode of Ask Epista, we share our expertise to get you to market faster with lower risk.

Christian Conradsen discusses how you can integrate serialization into your entire supply chain, as you’re creating it. Watch to learn more about:

  • What is Serialization and how does it fit into your existing supply chain?
  • What are the requirements for a Serialization project? What kind of challenges do small companies face?
  • What tasks are involved in implementing a Serialization solution on top of your existing supply chain?
  • What about preparation and execution of the project?
  • What happens after Go-Live?

Watch the episode here

Software as a Medical Device (SaMD)

Life Science companies are challenged to reconcile the ever-evolving world of SaMD (Software as a Medical Device) with patient safety and regulatory compliance. To help with this, we’ve put together advice from our SaMD experts.

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

In this episode, our experts examine the definition of SaMD and intended use cases. They drill down into the decision tree to help you determine the correct classification for your SaMD, including an examination of rules 9, 10 and 11. They discuss FDA and EMA definitions and classifications of SaMD. And they address where the NBs fit into the picture. Don't miss this information packed episode of Ask Epista!

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

AI and Machine Learning are trending in the Life Science industry. And they’re particularly relevant to SaMD. Watch this episode to learn more about:

  • Intended use
  • QMS requirements for both EMA and FDA
  • Validation, solution impact, and classification
  • Special characteristics
  • Discuss the domains where AI and ML are used, including current US trends
  • Challenges – what’s the big deal?

Watch the episodes here

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