Clear strategy, compelling argument and well-rehearsed preparation are the keys to winning at an 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...

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...

The introduction of a new medicinal product to the US market follows a complex process that may extend many years from the initial discovery through to the US Food and Drug Administration (FDA) approval and market launch. There are many factors during the product...

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...

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...

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...

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...

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...

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...

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...

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