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...

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...

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...

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...

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...

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...

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...

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...

Pages

  • 1
  • 2