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Discover our expert insights

We like to keep our readers up to date on complex HealthTech development issues, the latest industry trends and updated guidelines to help you to solve a problem or make an informed decision, and learn how VCLS can provide you with tailored solutions to effectively move your product development forward.

Webinar

Mar 14 2025

Ask the Experts: Navigating FDA & EMA CMC Expectations for Cell and Gene Therapy Product Development

Published on: Mar 14th, 2025 During the session, o...

  • Cell & Gene Therapy
  • FDA
    • ...
  • ...
Webinar

Oct 18 2024

How to master both Marketing Authorization and Joint Clinical Assessment successfully?

How to master both Marketing Authorization and Joi...

  • EMA
  • Market Access
    • ...
  • ...
Blog

Nov 20 2024

The SoHO Regulation: A Step Forward in European Health and Safety

EU has recently introduced a new regulation for su...

  • CMC
Webinar

Feb 20 2024

Demystifying the US IND process for initiation of clinical trials

Published on: Feb 20th, 2024   Submitting an Inves...

  • Regulatory strategy
  • FDA
Blog

Jun 17 2024

De-risk Clinical Trials by Starting with Patient Insights and their Integration

Understanding the perspective and preferences of p...

  • Clinical Trials
Case study

May 30 2024

Building an Efficient Path Towards Phase 2 Clinical Study in the US for a Live Biotherapeutic Product (LBP)

A South Korean biotech had developed a live biothe...

  • Microbiome
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Ask the Experts: Navigating FDA & EMA CMC Expectations for Cell and Gene Therapy Product Development
Webinar
  • Cell & Gene Therapy
  • FDA
    • ...
  • EMA
  • CMC

Ask the Experts: Navigating FDA & EMA CMC Expectations for Cell and Gene Therapy Product Develop...

Published on: Mar 14th, 2025 During the session, our CMC regulatory experts shared firsthand insight...

Mar 14 2025
Webinar
  • EMA
  • Market Access
    • ...
  • Regulatory strategy

How to master both Marketing Authorization and Joint Cl...

How to master both Marketing Authorization and Joi...

Oct 18 2024
Ask the Experts: How to leverage regulatory interactions to de-risk Microbiome products development in the EU and the US
Webinar
  • Microbiome

Ask the Experts: How to leverage regulatory interaction...

Published on: Aug 8th, 2024 Microbiome science has...

Aug 08 2024
Demystifying the US IND process for initiation of clinical trials
Webinar
  • Regulatory strategy
  • FDA

Demystifying the US IND process for initiation of clini...

Published on: Feb 20th, 2024   Submitting an Inves...

Feb 20 2024
Getting an Early Access Program Off the Ground Safely
Webinar
  • Clinical Trials
  • Market Access

Getting an Early Access Program Off the Ground Safely

Published on: Dec 12th, 2023   Embracing an Early ...

Dec 12 2023
Ask the Experts: Unleashing the potential: Unveiling the regulatory drivers of the SaMD market in the US and EU
Webinar
  • Regulatory strategy
  • Digital Health
    • ...
  • Medical Devices

Ask the Experts: Unleashing the potential: Unveiling th...

Published on: Oct 12th, 2023   Software as a medic...

Oct 12 2023
Ask the Experts: How to use microbiome as an innovative diagnostic tool
Webinar
  • Microbiome

Ask the Experts: How to use microbiome as an innovative...

Published on: Sept 20th, 2023   Over the past deca...

Sep 20 2023
Key CMC and NC considerations for cell and gene therapy development
Webinar

Key CMC and NC considerations for cell and gene th...

  • Cell & Gene Therapy

Key CMC and NC considerations for cell and gene therapy...

Published on: Jul 3rd, 2023 ATMPs (Advanced Therap...

Jul 03 2023
Ask the Experts: EU-CTR – How to tackle the Requests for Information (RFIs) Challenge?
Webinar
  • EMA
  • Clinical Trials
    • ...
  • Clinical Studies

Ask the Experts: EU-CTR – How to tackle the Requests fo...

Published on: Apr 6th, 2023   The EU CTR (Clinical...

Apr 06 2023
Ask the Experts: MHRA’s Innovative Licensing and Access Pathway (ILAP)
Webinar
  • Regulatory strategy
  • Licensing and Access Pathway
    • ...
  • UK MHRA

Ask the Experts: MHRA’s Innovative Licensing and Access...

Published on: Feb 6th, 2023   In its new role of a...

Feb 06 2023
Ask the Experts: QPPV – What is it?
Webinar
  • EMA
  • Regulatory strategy
    • ...
  • Clinical Studies
  • Vigilance

Ask the Experts: QPPV – What is it?

Published on: Dec 28th, 2022   Before submitting y...

Dec 28 2022
Patient Engagement Explained: Insights from a Patient, a Patient Association and a Pharmaceutical Company
Webinar
  • Clinical Trials

Patient Engagement Explained: Insights from a Patient, ...

Published on: Aug 30th, 2022   Have you wondered a...

Aug 30 2022

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