Scientific advice in Europe – where to go?

Both national and central scientific advice are important mechanisms to gain feedback from competent authorities during drug development. Your choice of adviser is highly dependent on your type of product, the stage of development, your budget and how much time you have at disposal. Today we are sharing a shortlist that might be helpful when… Fortsätt läsa Scientific advice in Europe – where to go?

”This medicine is great!”

Why can’t I just say that? Pharmaceuticals aren´t chocolate and when it comes to its promotion, ethics is key.The pharma industry has a set of ethical rules, complementing the national legislation on marketing. The rules cover a range of areas such as promotional materials, interaction with health care professionals, patient organisation collaboration, transfer of value… Fortsätt läsa ”This medicine is great!”

Orphan drug designation

To achieve orphan designation, it takes more than just proving your drug is intended to treat a rare disease. Besides prevalence data, in EU you will need to show potential for a significant benefit compared to any existing treatments including non-pharmacological methods such as surgery. So US ODD may be the first step. Together with… Fortsätt läsa Orphan drug designation

Need help with your Investigator’s Brochure?

Do you have all your data but no one to put it in writing in time for submission? A medical writer may be just what you need! Give us call.   #regfile #medicalwriting #investigatorsbrochure #ib

eCTD publishing

CTD (Common Technical Document) describes the organisation of the regulatory documents supporting the authorisation of medicinal products.     The eCTD (electronic CTD) is a harmonised technical solution to implementing the CTD electronically. It consists of PDF documents, arranged in a set structure with defined folder and document names. eCTD is to be used when… Fortsätt läsa eCTD publishing

Meet the family

Did you know that RegFile is part of the brilliant consultancy group Center for Translational Research? Last week the CTR siblings met in Sigtuna, to discuss how to develop our complementary services and collaboration to support our clients even better. Current business trends were also on the agenda to make sure we stay on top… Fortsätt läsa Meet the family

Happy Easter

Clinical overview – eCTD module 2.5

The Clinical Overview is one of the most important documents on your way to Marketing Authorisation. It is an in-depth critical analysis of your complete drug development programme and its results, including discussion and interpretation of clinical findings. The overview presents the strengths and limitations of your programme and study results and analyse clinical benefits… Fortsätt läsa Clinical overview – eCTD module 2.5

How to succeed with CMC variations

5 tips1.      Make sure a Change Control (CC) case is opened and that a project is set up, together with relevant co-workers. This is important, also for smaller changes. 2.      Correct classification is key. Study the classification guideline carefully and ask a colleague for advice if you feel unsure. For non-standard variations, always confirm the classification with… Fortsätt läsa How to succeed with CMC variations

Which are the 3 key Medical Writer skills?

Strong scientific skills– Literature/reference searching– Critical review of scientific literature and reports Strong written communication skills– Accurate and thorough summaries– Comprehensive and clear messages– Correct Medical terminology Strong analytical skills– Interpretation of research data and statistics– Visual presentation of data (diagrams, tables, graphs) At RegFile we are happy to support you with your Medical Writing.