Drug Development Consultant & Regulatory Consultant

Course

An Introduction to First in Man Clinical Trials Regulations

Back by popular Demand for 2010, Edinburgh 5th May 2010

We were not planning to run this course again in this format and most definitely not at this price, can you believe its still only £500, but we had a direct request from one of our very best clients to run it again for a new team member, which is why we are running it and why we are doing it in Edinburgh as apposed to our usual Leeds.

Only 10 Places 7 Places

We have booked a lovely venue in Edinburgh City Centre, its great but it does only hold 10 people so don’t delay, as I type this I have already got bookings so don’t delay.

Wow I knew this was going to be popular but I have not even started the promotion yet and 3 places have been booked..

OK Damien but what is the course?

Well its an introductory course on the regulatory aspects of planning a Phase I/II clinical trial, and how these trials should progress the development of your technology. The course is presented by a seasoned professional, who has planed and implemented clinical trials for large pharmaceuticals companies, and small spin out biotechnology companies and national defence organisations, presents a tried and tested course, that will arm anybody planning, running, reporting and purchasing a Phase I/II clinical trial with all they need to know.

That all sounds great but its £500!

Yeah, £500, but when we run this course in London its sells out at £1500, but due to the expense of running a course in London we have to charge that. and let me tell you getting this kind of training will make sure your projects are accelerating through the regulations, this is not a cost its an investment that will return infinitely.

This is a full on learning experience, you will come away with the skills and knowledge to really fly. its not a pitch fest, we will not stand up there telling you why you need to employ us to do this for you, but if you come on our course and buy consultancy in the areas covered we will refund the cost of the course to you. (upto 10% of the overall consultancy fees upto £500).

Again this all sounds fantastic but I am not sure its right for me?

Its not right for everybody, but those that are developing technologies in healthcare at whatever level will find this incredibly powerful, they will get a whole bushel of new skills and insights, delivered by a team that do it every day. Don’t forget the regulators are getting more and more pragmatic and the barriers to human clinical studies are getting lower all the time, and in the current market pre-clinical is getting cheaper, clinical programmes are now within the financial reach of many small companies and academic projects.

OK Damien, turn me into an Expert, how do I sign up

You can fill in the form on the brochure (Introduction of First In Man Regulations Course XVIII), Or drop me an email at damien.bove@IDAconsultants.com to reserve a place. And of course we have Easy Payment:

  • Pay now
  • Pay in the new financial year
  • Pay by credit card
  • We can invoice you
  • Split your payment either side of the financial year

Damien, what guarantee do I get?

I am that positive you will get so much from this course that if you don’t feel it was worth while attending I will personally give you your money back.

OK Damien you best give me more details!

Course Objectives

The introduction of the clinical trials directive introduced in 2004, and more recent updates has introduced a heightened level of regulation for First In Man studies.

The course is a one day introduction to the regulations of Phase I/II clinical trials, it will provide you with the information and expertise to plan the regulatory aspects of your clinical trial. It will introduce the main regulatory bodies, what their roles are, what you need to do to satisfy them. As well as these regulatory aspects it will give you a broader insight into Phase I/II clinical trials, their role in the drug development pathway and help you to understand how they can be used to best add value to your technology.

Your Course Leader

The course is lead by Dr Anthony Lockett, a medical doctor who has spent the last 18 years of his professional life, planning, implementing, running, reporting and monitoring clinical trials. He has a massive amount of practical experience and a deep understanding of the regulatory requirements and has put this course together in order to bring the subject alive for the next generation of clinical trial specialists.

Who should attend?

The course is aimed at anybody who finds that they need to get involved in a Phase I/II clinical trial, be that in the planning, running or purchasing one. Attendees are typically from Pharmaceutical and Biotechnology companies, academic researchers and research physicians. If you think you have a good basic understanding of Phase I/II clinical trials but would like to advance your practical knowledge this course will help you achieve that, for those students looking for a more in-depth understanding we also run a two day course, please get in touch to find out more about that.

Logistics

The course will be held at the Royal Over-Seas Club, Princess Street, Edinburgh The event will be fully catered, with refreshments throughout the day and a hot lunch will be provided. (please notify of any dietary requirements when making your booking)

Course Content

  • Introduction to regulatory affairs for First in Man clinical trials.
    • The need for regulatory affairs for First in Man clinical trials
    • Current regulatory requirements for First in Man clinical trials
    • The differences between legislation and guidelines
    • Why it is important to adhere to the follow the regulatory pathways for First in Man Clinical trials.
  • Case Studies – Tagenero
    • Review of TGN 1412 – why preclinical testing failed to predict toxicity in man.
  • Latest developments in regulatory guidelines for First in Man clinical trials.
    • The impact of changes to the EU clinical trials directive and guidelines on commercial and non-commercial bodies.
  • The function of the different regulatory bodies within the Europe
    • Which regulatory body is relevant to your clinical trial
    • The MHRA and their role
    • Responsibilities of the European Medicines Agency (EMEA)
    • The system for submitting an application for authorisation to the EMEA
    • An overview of the who, what, when and why of ethics committees.
  • The requirements for submitting an application for regulatory approval.
    • The application submission system
    • When to apply for approval within Europe

Fees & Registration

£500 per participant

Download the brochure (think before you print) An Introduction to The Regulations of Phase I/II clinical Trials, XIII