Regulatory Pathways in the EU - overview
Prior to initiating a drug development program there are certain questions and considerations that should be answered with the main aim...
Future Trends in Healthcare
Intro The pharmaceutical industry has experienced significant growth during the past two decades, and pharma revenues worldwide totalled...
What to keep in mind as a developer of Drugs for Rare Diseases?
The definition of rare disease varies across countries and jurisdictions, but it usually takes into account disease prevalence, severity...
Best practices for development of pediatric medicines in the EU
What became evident with the introduction of the Paediatric Investigation Plan (PIP) procedure in Europe is that Regulatory Experts need...
EU Rewards and Incentives for Pediatric development
EU Paediatric regulation - (EC) No 1901/2006 entered into force on 26 Jan 2007. Its purpose was to improve the health of children in the...
How to find an excellent Regulatory Affairs Consultancy?
When working on your drug development projects, you will need to perform a thorough analysis of the information and resources needed to...
Do you use Regulatory intelligence in your daily work?
To stay current with the rapidly changing landscape, regulatory professionals must continuously monitor and identify relevant regulatory...
Daily challenges of Regulatory Affairs Experts and how to overcome them
Let’s be honest, the number of tasks a typical Regulatory Affairs manager is asked to perform during a week can be brutal. Meetings,...
How to become a better Regulatory Affairs Strategist?
Have you ever been told that you are a strategic thinker? As a Regulatory Affairs professional, this is one of the qualities that can...
101: FDA Meetings
As part of any product development it is of paramount importance to build constructive relationships with Regulatory Agencies. If you...