Webinars

Jan 21 2026

Agile Quality by Design: A Practical Guide for Modern Pharmaceutical Development

• CMC
• Regulatory strategy

Dec 22 2025

Avoiding Delays and Missed Opportunities in Japan: Clinical and Regulatory Strategies for Ex-Japan Biopharma

• Regulatory strategy

Dec 10 2025

Early Regulatory Strategy: Early Regulatory Interactions and Accelerated Programs Integration in your US/EU Development Plan

• Regulatory strategy

Oct 15 2025

Real-World Evidence in the Nordics – Insights for Pharma

• Market Access

May 27 2025

Streamlining GMO Applications in Clinical Trials: Global Framework and Strategic Considerations

Published on: June 25th, 2025 In this webinar, we provided an overview of key regulatory and strategic considerations for clinical trials involving investigational medicinal products consisting of or containing genetically modified organism (GMO-IMPs), such as gene therapies, viral vector-based vaccines, genetically modified bacteria, etc. The covered topics include:  The presentation of regulatory frameworks (EU, US, […]

• Cell & Gene Therapy
• Clinical Trials
• Regulatory strategy

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, our CMC regulatory experts shared firsthand insights on FDA and EMA expectations for cell and gene therapy (CGT) product development. Drawing from extensive experience across multiple projects and direct interactions with regulatory agencies, they discussed key feedback trends, common challenges, and best practices for a smooth regulatory […]

• Cell & Gene Therapy
• CMC
• EMA
• FDA

Oct 18 2024

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

Published on: Oct 18th, 2024 The European Union is transforming its health technology assessment process with the introduction of the Joint Clinical Assessment (JCA) under the new HTA Regulation. This major change aims to streamline clinical evaluations across member states, harmonizing the process and improving market access for innovative therapies. The EU JCA will be […]

• EMA
• Market Access
• Regulatory strategy

Aug 08 2024

Ask the Experts: How to leverage regulatory interactions to de-risk Microbiome products development in the EU and the US

Published on: Aug 8th, 2024 Microbiome science has grown over the past years with high potential to provide innovative, efficient, and targeted solutions to various health issues. Innovative technologies and health products based on and/or targeting microbiome have emerged, raising unprecedented questions as part of their development. Navigating this emerging field, developers and regulators have […]

• Microbiome

Feb 20 2024

Demystifying the US IND process for initiation of clinical trials

Published on: Feb 20th, 2024 Submitting an Investigational New Drug (IND) application to the US FDA is a significant step in the development of a new drug or biologic product. In this webinar, we covered the steps and key components required for comprehensive and compelling submission, as well as strategies for effective communication with the […]

• FDA
• Regulatory strategy

Dec 12 2023

Getting an Early Access Program Off the Ground Safely

Published on: Dec 12th, 2023 Embracing an Early Access Program (EAP) presents a strategic avenue for creating valuable opportunities for patients and companies. This webinar explores the strategic advantages of implementing an Early Access Program, highlighting how it serves as a dynamic tool to engage with patients and collaborate with payers. It aims at getting […]

• Clinical Trials
• Market Access

Oct 12 2023

Ask the Experts: Unleashing the potential: Unveiling the regulatory drivers of the SaMD market in the US and EU

Published on: Oct 12th, 2023 Software as a medical device (SaMD) has been used in the healthcare sector for many years, particularly in the space of imaging and treatment planning. At the same time, the medical device industry and regulations were still viewing this space as mostly hardware-centric; therefore, the evolution and understanding of the […]

• Digital Health
• Medical Devices
• Regulatory strategy

Sep 20 2023

Ask the Experts: How to use microbiome as an innovative diagnostic tool

Published on: Sept 20th, 2023 Over the past decade, innovations in both sequencing technology and computational biology have led to a growing interest in profiling human microbiota for therapeutic and diagnostic applications. Recent research has highlighted how human microbiome is increasingly demonstrated as a central component of personalized medicine. Beyond well known the inter-individual variability, […]

• Microbiome

Jul 03 2023

Key CMC and NC considerations for cell and gene therapy development

Published on: Jul 3rd, 2023 ATMPs (Advanced Therapeutic Medicinal Products) in Europe, or CGTs (Cell and Gene Therapies) as they are known in the US, represent the fastest growing arena in today’s global biotechnology and biopharmaceutical sectors. Despite a slow start, there were at the end of Q1 2023 approximately 20 cell and gene therapies […]

• Cell & Gene Therapy

Apr 06 2023

Ask the Experts: EU-CTR – How to tackle the Requests for Information (RFIs) Challenge?

Published on: Apr 6th, 2023 The EU CTR (Clinical Trials Regulation) no. 536/2014 became effective on 31 January 2022. Among all the challenges, Sponsors often foresee the challenge of RFIs as being a worrisome topic. Our experience has shown that indeed, for CTAs submitted under the EU CTR, the coordinated assessment of Part I can […]

• Clinical Studies
• Clinical Trials
• EMA

Feb 06 2023

Ask the Experts: MHRA’s Innovative Licensing and Access Pathway (ILAP)

Published on: Feb 6th, 2023 In its new role of an independent regulator, the UK’s MHRA regulatory agency is emerging as a flexible and welcoming supporter of new and innovative healthcare technologies and products. Since its launch, the Innovative Licensing and Access Pathway (ILAP) scheme has attracted continual attention of the industry. It has been […]

• Licensing and Access Pathway
• Regulatory strategy
• UK MHRA

Dec 28 2022

Ask the Experts: QPPV – What is it?

Published on: Dec 28th, 2022 Before submitting your marketing application in Europe or the UK, thinking about the PharmacoVigilance System and its Qualified Person (QPPV) is key for successful product development – at the time of submission, a PV system must be in place and a QPPV must be declared. In this session, we aim […]

• Clinical Studies
• EMA
• Regulatory strategy
• Vigilance

Aug 30 2022

Patient Engagement Explained: Insights from a Patient, a Patient Association and a Pharmaceutical Company

Published on: Aug 30th, 2022 Have you wondered about the role of patient engagement in healthcare product development?Currently, there is a huge emphasis on the importance of using patient experience, preferences and insights. All this in an effort to inform the decision-making process of regulatory authorities and payers. The Future of Patient Engagement Both the […]

• Clinical Trials

Jun 20 2022

Regulatory pathway and agency interaction: The EU vs the US

Published on: Jun 20th, 2022 The introduction of a new medicinal product to the US and European market follows a complex process that may extend many years from the initial discovery through to the FDA and EMA approval and market launch. There are many factors during the product development that impact the success of drug […]

• EMA
• FDA
• Orphan & Rare Disease

Apr 14 2022

Ask the Experts: EU CTR/CTIS: Adoption and Early Experience

Published on: Apr 14th, 2022 The EU Clinical Trials Regulation no. 536/2014 became effective on 31 January 2022 and the first approved trials are now showing up in CTIS. Nevertheless, planning ahead for a successful submission and knowing what to expect from the new system can be a challenge. In this session, our experts answered […]

• Clinical Studies
• Clinical Trials
• EMA

Jan 31 2022

Controversial and debated topics in Clinical Trials

Published on: Jan 31st, 2022 A well thought out clinical strategy is critical for a clinical study, our experts of clinical study talk about the following items in this webinar Impacts of correct study design (using some practical examples) Choice of expertise in protocol and study optimization Feasibility methodology in the choice of centers Choosing […]

• Clinical Trials

Jan 07 2022

Interplay between ICH and Data Privacy – GDPR

Published on: Jan 7th, 2022 As professionals in the life sciences industry, we work in a regulated environment and we are a key element in the compliance process of our organisations to the regulations and guidelines in place. In addition to Clinical Good Practices (i.e. ICH E6) and other ICH guidelines, most countries in Europe […]

• EMA
• Microbiome

Dec 03 2021

Ask the experts: EU regulatory framework for microbiome product development

Published on: Dec 3rd, 2021 Microbiome-based products, such as Live Biotherapeutic Products (LBPs) are very innovative, therefore associated with many challenges. Navigating the complex regulatory pathway is one of these major considerations. They can fall under several regulatory statuses, in both the food and medical arenas. Their intended use, target population, presentation form, composition, mode […]

• EMA
• Microbiome

Oct 12 2021

Ask the experts: Will you be ready for the new IVD regulation?

Published on: Oct 12th, 2021 The major switch from IVD directive to IVD regulation is happening next year on the 26th May 2022. Notified Bodies (NB) and IVD legal manufacturers are getting ready for this huge change. From the 40 pages directive to a 157 pages Regulation, from 80% of IVD being self-certified without the […]

• EMA

Aug 03 2021

Patient access to Advanced Therapies in Europe 2009-2021: from early access failures to current challenges

Published on: Aug 3rd, 2021 The recent announcement of BlueBirdBio to wind down its European commercialisation efforts due to access and pricing challenges for its gene therapy products has put a new spotlight on the market access and payer environment for advanced therapies in Europe. In this webinar VCLS market access experts analyse the commercial […]

• Cell & Gene Therapy

May 04 2021

How to use Scientific Advice to enhance your product development strategy

Published on: Mar 4th, 2021 Scientific Advice (SA) is one of the important interactions a developer can have with a regulatory agency (national or European level). It can facilitate the development and availability of high-quality, effective and acceptably safe medicines, for the benefit of patients. In this session, we answer the questions on SA such […]

• EMA

Mar 01 2021

Ask the Experts: How to have an effective INTERACT meeting with the FDA

Published on: Mar 1st, 2021 INTERACT meeting is an informal non-binding consultation with the CBER at FDA. It allows sponsors to obtain preliminary informal consultation for innovative investigational products at an early stage of development on issues that are not yet at the pre-IND meeting phase. Although this meeting is highly recommended by FDA, an […]

• FDA

Jan 11 2021

What are the reimbursement pathways for innovative digital health technologies?

Published on: Jan 11th, 2021 Innovative digital health solutions are finding their ways into routine patient care in the US and Europe, and different payers are starting to cover software-based healthcare products just like they may cover pills and physician visits. But precisely which digital technologies get reimbursed and how? Is this a business model […]

• Digital Health

Nov 06 2020

Entering US market: FDA’s consideration on digital health technologies

Published on: Nov 6th, 2020 VCLS is glad to organize this virtual event with the Innovation Center Denmark in Boston in collaboration with Welfare Tech to help you understand the Boston landscape of innovation and the opportunities it represents for Danish entrepreneurs and their innovative solutions. In this particular session, Johnny Hansen, our Copenhagen based, […]

• Digital Health

Nov 02 2020

How to Secure Early Stage Development and First-In-Human Studies

Published on: Nov 2nd, 2020 We co-organized this digital event with Biopôle Lausanne. On this Webinar:   Biopôle presentation (Olivier Philippe)                 Let us get ready for First-in-Human-Study (by VCLS)                 Coralie and Fréderic P. will present the main challenges typically faced by […]

• Clinical Trials

Sep 17 2020

How to create an aligned global co-development strategy for drug with device component combination products

Published on: Sept 17th, 2020 Drug delivery technologies are becoming increasingly complex and integrated, combining various advanced technologies with the intent to deliver the drug with the right dose, at the right time and right location, in the right way. The goal of this webinar is to look at this drug-device co-development journey from 5 […]

• Medical device

May 11 2020

Medical Device Software Development: How to Build your EU/US Strategy

Published on: May 11th, 2020 This webinar helps developers of e-health/m-health solutions to better understand the regulatory environment relevant to their digital technologies in Europe and in the US and how to best overcome these challenges to maximize the chances of a timely and successful market launch on these markets. This webinar outlines how e-health/m-health […]

• Digital Health

Mar 18 2020

Deep Dive into FDA’s Expedited Programs for Drug Development

Published on: Mar 18th, 2020   If you are developing products for serious and life-threatening illnesses with unmet medical needs, there are several mechanisms offered by FDA that can accelerate your product development and the review of your BLA/NDA. This webinar will provide you some background on each of the tools and how you can […]

• FDA

Sep 25 2019

Unlocking the EMA Meetings: the Process and How to Prepare Adequately

Published on: Sept 25th, 2019 Clear strategy, compelling argument and well-rehearsed preparation are all key to having a successful EMA meeting, no matter if it is a Scientific Advice meeting or a CHMP meeting. In this webinar, we will use CHMP meeting as an example to walk you through the complex processes and share insights […]

• EMA
• Regulatory strategy

Apr 09 2019

To Go or Not To Go Into Parallel Consultation

Published on: Apr 9th, 2019 Are you wondering about the feasibility of parallel consultation, what sponsors should be aware of, as well as the opportunities and pitfalls of seeking this process? Here is to clarify your doubts with case studies how easy and feasible is the parallel consultation in practice, what should the sponsors be […]

• EMA
• Market Access

Nov 20 2018

Advanced Therapy and Medicinal Products: How to overcome the hurdles from bench to clinic ?

We will review challenges in translation required to develop the ATMPs pharmaceutical product (cell and gene therapy products) from nonclinical to the clinical stage, as well as the challenges related to the determination of proof-of-concept, how to choose clinical dose from nonclinical studies and address the nonclinical questions required to demonstrate ATMP product safety before […]

• Cell & Gene Therapy
• Market Access

Sep 19 2018

Pitfalls and Best Practices When Conducting a Clinical Study

Published on: Sept 19th, 2018 Since the development of the ICH GCP guidelines, clinical trials are more and more complex in a stringent regulatory framework. The process of conducting a clinical trial is a costly step and the number of wasted dollars is staggering. Setting up and conducting a clinical trial is not easy and […]

• Clinical Trials

May 07 2018

Efficient Drug Development for Promising Medicines: Comparative Introduction to EU & US Regulatory Tools

Published on: May 7th, 2018 With a lack of adequate therapeutic options for the great number of patients living with serious diseases, both the EMA and FDA have, independently, taken measures to address this gap by enhancing the development process, leading to an increase in the availability of significant therapies. In July 2012, the FDA […]

• EMA
• FDA

Apr 05 2018

Understand the Main CMC Challenges to Improve ATMP Development

Published on: Apr 5th, 2018 Recent clinical successes in cell therapy and gene therapy have shown how fast this field is advancing. While the clinical outcomes are leading the developments in this field, the chemistry, manufacturing, and control (CMC) are struggling to meet development needs, global regulatory compliance and timelines. The intricacies of these advanced […]

• Cell & Gene Therapy

Nov 27 2017

Opportunities for early dialogue with the EMA and HTA bodies. Optimizing product development to ensure commercial success

Published on: Nov 30th, 2017 Early engagement and scientific advice with European Medicines Agency (EMA) is a key driver to faster and more often, successful registration. In addition, early discussion with HTA bodies and other stakeholders can be critical towards early patient access and commercial success in Europe. There is growing interest in the EMA/EUnetHTA […]

• EMA
• Market Access

Jun 13 2017

Changes and Impacts of the New EU IVD Regulatory Requirements with CDx Specifics

Published on: Jun 13th, 2017   The new EU IVD regulation will introduce major changes that will greatly impact IVD product development and CE marking. These changes will introduce delay to market access and increased cost to CE marking IVD medical devices in Europe. As an example, there will be a premarket review of technical […]

• Medical device

Apr 27 2017

MICROBIOME: Navigating Regulatory and CMC Technical Development Roadmap

Published on: Apr 27th, 2017 Advances in genomic and big data analysis trends have significantly increased the interest of academia in the symbiotic relationship between the human body and its microbiome. In particular, relationship with the immune system, disease aetiology and outcome is being better articulated and continues to gain the attention of companies and […]

• Microbiome

Mar 09 2017

9 Challenges During Cell and Gene Therapy Development in Europe, and How to Tackle Them

Published on: Mar 9th, 2017 Developing gene and cell-based medicinal products (referred to as “Advanced therapy medicinal products” in Europe) still represents huge challenges. At the same time, these breakthrough therapies bring hope for filling unmet medical needs and curing life-threatening diseases. Knowledge of the European regulatory framework for ATMPs and their main development hurdles […]

• Cell & Gene Therapy

Feb 28 2017

FDA Consideration for e-Health

Published on: Feb 28th, 2017   Anastacia Bilek, Ph.D. will share her experience in the regulation of m-Health products as a guide for product developers. She will discuss the definition and uses of m-Health, the regulatory environment for m-Health, and the key development and evaluation activities of m-health technologies.

• Digital Health
• FDA

May 31 2016

Development and Registration of m-Health Technologies for the EU Market

Published on: May 31st, 2016 e-health technologies are already today starting to revolutionize the therapeutic processes and patients management paradigm. Unfortunately, e-health developers are very often uncomfortable with the regulatory maze they have to navigate into (or are simply unaware of it) until their e-health products could be placed on the European market. Key learning […]

• Digital Health

Apr 26 2016

Preparing Clinical and Product Development Documentation for Public Release

Published on: Apr 26th, 2016 The European Medicines Agency’s initiatives to increase the transparency of clinical trials, and provide an access to summary study results and raw data from trials sponsored by the pharmaceutical industry, as well as any document submitted to the EMA throughout development, remains the subject of an intense public debate. With […]

• Publishing

Mar 10 2016

10 Things to Know Before Entering the European Market

Published on: Mar 10th, 2016 Expanding product development to an overseas market can often be difficult to navigate. Thankfully we can help you to find the most effective path to realize your products’ commercial potential. Kelsey Mower, Associate Director at VCLS will share her experience on 10 essential aspects, from the interactions with European agencies, […]

• Regulatory strategy

Nov 03 2015

Managing a Global Publishing Strategy

Published on: Nov 3rd, 2015 Having an electronic submission strategy in place is critical in supporting the transition to eCTD. Advanced planning and an understanding of eCTD submission requirements in the various regions are important steps in filing a successful electronic submission. With eCTD becoming the mandatory submission format in most major markets by 2017/2018, […]

• Publishing

Jun 25 2015

Paediatric Investigation Plan: Requirements, process, and comparison with US PSP

Published on: Jun 25th, 2015 A Paediatric Investigation Plan is on the critical path to obtain market approval in Europe, even if the condition does not occur in children. A PIP must be agreed with regulators before submitting a Marketing Authorization Application. If PIP requirements can be waived or deferred under specific circumstances, the negotiation […]

• EMA
• FDA

Mar 04 2015

Initiating Clinical Trials in the EU: Current Scenario and Upcoming Changes

Published on: Mar 4th, 2015 With 28 member states and associated countries, initiating a clinical trial in the EU is perceived by many in the industry to be a daunting challenge. Upcoming changes in the regulations will change the clinical trial approval process, and make it much easier for pharma and biotech companies. Objectives of […]

• Clinical Trials
• EMA