As you want to start regulatory interactions in Europe for an orphan drug, you may face many challenges or miss game changing opportunities. Indeed, the European Medicines Agency (EMA) provides specific incentives to companies who are granted ODD for…
Thanks to early access programs, drugs are on average available in France 200 days before their first regulatory approval (FDA or EMA). In this context, early access programs can be extremely attractive for pharmaceutical companies developing life - transforming therapies.…
Our experts at BlueReg are giving advice on how to effectively manage your promotional compliance for pharmaceutical products in EU & beyond. The different subjects discussed in the webinar are : Why is your promotional campaign key to the success…
Our experts at BlueReg are covering the Early Access Programs specific to France (ATU), and how to take advantage of it. The different subjects discussed in the webinar are : Why Early Access (ATU) for new innovative drugs in France…
Our experts at BlueReg are covering the different pathways to accelerate your medicinal product launch in Europe. The different subjects covered are : 1. Regulatory Strategy - How to prepare the regultory launch sequence for your first medicinal product in…