New FDA review rules, new EMEA & FDA paediatric rules and new EMEA safety rules are going to torpedo your development project and knock a large amount of the value out for your IP if your not ready!
We have the course that will ensure your well prepared, and at only £500 its great value.
FDA: At the end of 2007, the USA government announced a wide ranging and disruptive review of the FDA mandate. It affects most element of what the FDA do and consequently what is required of the drug development industry. These new rules are now in force and companies need to be ready to deal with it. If your not doing the right things at Proof of Concept stage you might find your not ready to go into man when you think you are, its going to impact the value of your IP and your credibility to investors.
Paediatric: the FDA and EMEA have put in place some tough new rules governing the area of Paediatric clinical trials (Its not just for paediatric drugs these rules will impact every programme). You have to have a plan for paediatric plan, and in the near future you will need to have started the implementation of that plan before they will consider your technology for approval. If your not ready and have not considered these things your going to wast time and reduce the value of your IP. As you go into man, this is when you need to start considering these things.
EUCTD: We all think we know how the Clinical Trials Directive was going to impact, but now that we have been living with these rules for some time now we can now see the reality of these rules and the exceptions that have been thrown up. You need to make sure your all over these rules as it will impact your future development.
We are running a course in February that will assist you tackle these issues are come out smelling of roses.
Damien Bové works as a drug development consultant (pharmaceutical or biotechnology), we work with our clients to define a development target, define a development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch using the contact form or email Damien at damien.bove@idaconsultants.com
