UK being the 2nd largest recruiter in the Clinical Research Field and the 3rd largest Clinical Research Industry having 20 leading CRO’s based in the UK is a promising land for Clinical Research. The regulations (EMEA and MHRA) that are a part of the course module will help students to work in any UK and European CRO’s.

Certificate in European Clinical Trials Management & Regulatory Affairs is a unique training program we offer for aspiring students, who wish to enter into the Clinical Research Industry or for the working professionals who wish to leverage their existing job profile to their needs. Session in our clinical trials simulator giving you hands on experience of how a UK trials unit operates.

This certificate is a four week course which is delivered in collaboration with ICR(UK).

ICR (UK) founded in 1978 is the premier organization for professionals in all aspects of clinical research. It is the largest professional clinical research body in Europe and India. It is a not-for-profit organisation, guided by a Board of Directors who are elected by the membership and is based at its Head Office in Bourne End, Buckinghamshire, UK. The president of ICR (UK) The President of the Institute is: The Rt Hon The Earl Howe, Opposition Spokesperson for Health in the House of Lords basically meaning that it has got the UK govt. support.

We are going to kick start our vigorous program with an over view of the European Regulatory affairs and legislations. By the end of the week we will have sessions with Reeds Scientific.

Reeds Scientific is UK’s largest recruitment agency in the field of Science. They would provide you with the soft skills you require while facing a job interview. They would provide you with advice on your CV, so that it is up to the mark and most importantly they would screen for any candidate whom they might be able to place in the UK. However we don not guarantee any participants a placement or a Job as a part of the course.It can be noted that UK has the third largest Pharmaceutical Industry in the world. The amount of job opportunities in Europe is tremendous.

Eastern Europe is now becoming the new hot spot for Clinical Trials. The only problem being is that let us move from the very USA and FDA centric knowledge to the EU and EMEA/MHRA. Let us grab the opportunity that Europe is offering.To name a few of the the leading pharma companies based at UK are

• GlaxoSmithKline
• Pfizer
• Astra Zeneca
• Merk & Co
• Wyeth
• Novartis
• Aventis Pharma
• Pharmacia Ltd
• Roche
• Lilly
• Sanofi-Synthelabo
• Bristol-Myers Squibb
• Johnson & Johnson
• Boehringer Ingelheim
• Novo Nordisk
• Abbott
• Bayer
• Schering Plough
• Schering Ag
• Lundbeck

Every week ends with a cultural trip to places in UK. This is to provide important insight into the understanding of UK along with learning technical content of the course. Week one would end with a trip to Cambridge the jewel in the crown of England’s heritage. Renowned as a seat of learning, its colleges continue to hone some of the world’s greatest intellects, its beauty to inspire poets and artists. A city steeped in history, Cambridge is also at the forefront of 21st century technology. It remains a magnet to those who desire both the experience of the old and the excitement of the new. It is also the place where Pink Floyd the band originated.

Cambridge:

• Old universities, its basically a town with students and teachers
• Global and largest location for phase 1 and proof of concept studies.
• Cambridge research park which has 1800 units which conducts clinical research commercially

Oxford:

• Maximum number of noble laurets in economics and science
• Number of world leaders passed out from Oxford university eg. Benazir Bhutto rajiv gandhi. President Zia, sonia gandhi, zardari his son,
• 1000 year old buildings which are used as colleges
• Some 30 odd colleges
• Decode of human genome project btw Oxford, Cambridge and MIT
• Phase 1 and 2 units, global locations

London:

• Financial capital of the world
• It is the single largest point from where money flows
• AIM alternative investment market (this funds the scientific research)It is bigger than NASDAQ
• M25 highway, the ring road concept originated from here
• Big pharma companies like GSK, PFIZER, and WYETH are located around here

The week two of the course you would learn about Morals and ethics in Clinical Research.

There would be a trip to a Pre Clinical Facilty and Visit to a Pharma Company with a strong UK base likely to be GSK, Pfizer, AstraZeneca or similar. The aim of the visit is to provide students a first hand insight into the working of a Multi National. There will be presentations made by the representatives of Key departments of the multinational company. Advice on Career options and a question and answer session will be held.

The week would end with a Regulatory Master class, trip to London and another session by Reeds scientific.

The Regulatory master Class is to cover the EU/UK legislations and Regulatory framework. This day would be taken by a "super star" or a top Uk/EU regulatory expert. A lot of time would be given to students to interact with the speaker and they would be able to directly advice you on how tackle regulatory case studies.

The week 3 will provide you with a hands on experience in Clinical trials in a simulator unit.

A simulator unit usually represents an actual clinical trial unit to provide you with a first hand experience in Clinical Trial Management. We would take you to Southampton General Hospital. This hospital has over 20 years of clinical trial experience. Here you would undertake a number of role play exercises under the supervision of our faculty wherein you will have to conduct exercises like seek patient consent, cope with the drug, mock cardiac arrests or anaphylactic shock, seeking regulatory approval, etc. This unit is a fully functional clinical trial unit having all the equipment required for a unit; since we have a mutual agreement with SGH we can use this unit for our sole purpose. This is a brilliant opportunity for students to experience how it is to be a part of a clinical trial and all the practicalities involved in it which the text books don’t teach.

After the simulator unit, you will be taken to the Milton Keynes General Hospital. Here you will get an opportunity to observe several clinical facilities like obstetrics, gynecology, oncology, gastroenterology, respiratory etc.

The week would end with debriefing on Practicals and a visit to Oxford.

Week four the last week would provide you with in-depth knowledge on Medical Writing, Pharmacovigilance in the EU. There will a project mostly a presentation that you would be doing in front of the entire faculty and a revision before the final examinations.

The total course fee is 1750 GBP.

*Fees valid for March 2010 only