What sort of questions can I ask?
Here are some examples of questions received:
With all the recent deals on immune-oncology (Novartis, Merck KgaA, etc) who is currently in the lead (top 5) to be first to market?
What is the landscape for pulmonary fibrosis drugs?
What is the procedure and guidelines to have a new chemical entity identified as “breakthrough therapy” by the FDA?
If a drug is approved mid-way through the year, and payers have an agreed formulary list from the start of the year that doesn’t yet include the new drug, can this be added mid-year?
Would you have a summary of the changes that are going to occur with the EU Clinical Trials Regulation?
What are the details on the procedure to follow in order to enter the German market for Medical Devices?
In Belarus, when conducting a clinical trial of an IMP against a marketed drug, does the marketed drug have to be relabelled with a study label?
What is the route to market for innovative diagnostics and medical devices from discovery through regulation, cost effectiveness assessment and adoption in the UK?
As a large medical device manufacturer with many legacy products will the new amendment to the Standard EN 62366:2008, amendment 1, published June 30th 2015 change the compliance status to the standard?
Can you provide me with a list of expedited approval pathways globally, for example FDA (breakthrough therapy, fast track, accelerated approval, priority review), EMA (adaptive licensing pathway, etc), Japanese PMDA, Health Canada, Swissmedic, Australian TGA.