New Research from TOPRA MSc Students

Dear Colleague,

TOPRA is committed to providing high quality information and part of that is to facilitate original and in-depth research. To that end we are distributing requests from MSc in Regulatory Affairs Students for participation in the research that they have to carry out as part of the MSc Project. In addition, we have previously sent out research towards an MBA, for which you will find a reminder below. We would be very grateful for your participation.

Kwame Ansah

The purpose of this survey is to obtain your opinion on the present status and possible future trends in the regulation of biologics. The results will be used as part of a TOPRA/University of Cardiff MSc project entitled "A comparison of the CMC regulatory requirements for biological and chemical entities: past, present and future".

The aim of the survey is to obtain your opinion on the subject. A summary of the results and key messages drawn from the survey will be shared with interested respondents. The survey will provide useful information on current opinion and future regulatory trends which could inform regulatory strategy. The conclusions drawn from the MSc project will also be shared with interested respondents. The survey is strictly confidential.

The survey should take no more that 10 minutes to complete.

Participate in the survey.

Thank you for participating in the survey. Your feedback is important.

MSc Student, University of Cardiff

Katherine Chorlton

My name is Katharine Chorlton and I am currently involved in a research project to assess the impact of the UK requirement to notify the competent authority of serious breaches of GCP or the trial protocol. I am also exploring whether there should be a requirement in all European countries to notify the competent authority of serious breaches of GCP/trial protocol to improve patient safety across Europe. This study is performed as partial fulfilment of the requirements of my MSc degree in regulatory affairs at the University of Wales.

TOPRA has very kindly offered to facilitate this survey.

Your participation in the survey will provide useful information. The survey comprises of 25 questions which should take approximately 10 minutes to complete.

Participation is strictly voluntary. All data from this project are confidential and used for research purposes only. Data from questionnaires are anonymous. Names of participants and companies will not be connected to the information and will not be reported in the MSc dissertation. Data will be collected both from industry and the MHRA, and if sufficient data obtained, results will be published.

If you would like to receive a summary of the results when complete, please indicate at the end of the survey.

Please access the survey here.

Thank you for your help. If you have any questions or concerns, please do not hesitate to contact me on +44 1223 471 471 or chorltonk@medimmune.com

Davina Stevenson

For the past 3 years I have been undertaking an MSc in Regulatory Affairs through TOPRA and the University of Wales. For my dissertation I have chosen to investigate regulatory intelligence services within various sectors of the pharmaceutical industry. Publication of this feedback should be interesting and informative particularly for anyone trying to promote regulatory intelligence within a company. Please email me if you would like a full copy of the report.

WHAT?

I have designed the questionnaire to look at the role and use of regulatory intelligence services within companies of varying sizes and specialities.

WHO?

Professionals working for the pharmaceutical industry, within various sectors, company sizes and roles. Even if you do not have a regulatory intelligence service, I'm interested in your views.

Please note that the questionnaire is anonymous (unless you enter your name for the prize draw) and data will be handled confidentially.

HOW?

Please click the link to the host site (SurveyMonkey.com) and follow through the questions. This should not take you more than about 10 minutes to complete, but the data I get back will be invaluable!

Any additional comments can be added at the end of the questionnaire.

Take Part in the Survey Now.

WHEN?

I would appreciate your time to complete this questionnaire as soon as possible, please.
INCENTIVES?

A full copy of the results can be emailed to you and may help you to tailor your own Regulatory Intelligence provisions.

Thank you in advance for your help with this!

Please call or email if you have any questions or would like to discuss further.

Davina

Senior Regulatory Officer

Mundipharma Research Ltd, Cambridge, UK

davina.stevenson@mundipharma-rd.eu

+44(0)1223 397336

REMINDER - John Cogan

REMINDER: John Cogan

Member Request for assistance with a survey for an MBA

This is a reminder for John Cogan's MBA Survey. John currently works in the IS function at Shire Pharmaceuticals, and is in the final year of his MBA at Warwick Business School. His Project & Dissertation (P&D) is on entry barriers and entry methods for biopharmaceutical companies wishing to enter China.

In this short survey, he would like your opinion on only a few questions and this should take no more than 5-10 minutes to complete.
Please access the survey here.

Many thanks, if you have any questions or concerns, please feel free to contact John at JCogan@shire.com or +44 1256 894116.