This is presentation for BII Clinical Trial Training Program

1. Advance Program in Clinical Trial, Research and Data Management Offered by: Bioinformatics Institute of India (12 months Weekend Classroom Program)

2. Advance Program in Clinical Trial, Research & Administration - Details Advance Program in Clinical Trial, Research & Data Management Discussions…… Clinical Trial Industry & Career Prospects Bioinformatics Institute of India INDEX

3. BIOINFORMATICS INSTITUTE OF INDIA

4. Bioinformatics Institute of India Bioinformatics Institute of India Classroom Programs Distance Participation Programs Online Programs Project / Trainings Publications Corporate Trainings

5. Weekend Classroom Program Bioinformatics Institute of India Advance Program in Clinical Trial, Research & Administration (Weekend Classroom Program)

6. Program Highlights The course would provide students with a theoretical and practical understanding of the issues involved in the design, conduct, analysis and interpretation of clinical trials. Advance Program in Clinical Trials Weekend Classes E-learning opportunity Guest Lectures of Industry Veterans Research Study Clinical Site Visits

7. CLINICAL TRIAL INDUSTRY & CAREER PROSPECTS

9. Clinical Trial Process

10. Leading Companies in Clinical Trial

11. Leading Companies in Clinical Trial

12. Clinical Trial Industry Source: Mckinsey Report 2003 2008 2010 Value (million USD) 50 200 1000 Revenue (Crore INR) 75 300 875 Full time staff Requirement 800 4000 20,000 Site – staff Requirement 1500 6000 30,000 Patient Load 10,000 50,000 300,000

13. Career Opportunities “ More than 50,000 professionals will be required in the field of Clinical research in India alone.” Source : Mckinsey Report Thus science, pharmacy and medicine graduates can look forward to exciting and rewarding career opportunities in clinical research.

14. Careers in Clinical Research Clinical Research Associate Clinical Research investigator Study Coordinator Data manager Biostatistician Regulatory Affairs Manager Clinical Trials Auditor Clinical Project Manager Clinical Research Manager Business development Manger Drug Safety Associate Medical Writer

15. Clinical Trial Quotations “ India is an emerging market with growing number of entrepreneurs foraying into research and healthcare. Indian government is creating an effective regulatory framework. Protection of patents and IPR is now improving. India has a better place than countries like China in the clinical trials field”, Dr Charles Pierce, president Global Clinical Partners, Inc. USA, said Source: Pharmabiz “ Indian contract research Organisations will have good chance to shine, Indian CROs are competitive compared to western companies. There are several advantages to global companies to outsource research service from us”Dr. Goutam Das ,CEO, Syngene International Pvt.Ltd. Source: Chronicle Pharmabiz

16. Advance Program in Clinical Trial, Research & Administration DETAILS

17. Program Objectives To provide students with a theoretical and practical understanding of the issues involved in the design, conduct, analysis and interpretation of clinical trials. Theoretical and practical understanding of clinical trial process Skills to scrutinize and analyze information essential features and stages in the conduct of a clinical trial, Understanding the ethical issues involved Understanding of uses and applications of intervention studies

18. Learning Outcomes Better Understanding of Good Clinical Practice & Standard operating procedures Can participate in design, conduct & management of Global Clinical trials Can contribute more effectively in Drug Development Can be employed for the conduction of Clinical Trials Handle regulatory affairs as per the changes in the statutory laws.

19. Program Methodology

20. Program Details Program Duration 12 months ( 9 months weekend classes + 3 months Research Project) Program Fees INR 35,000/- Payable at once on the time of joining Ist Installment INR 12,000 (on joining time) IInd Installment INR 12,000 ( after 2 months) IIIrd Installment INR 12,000 (after 4 months)

21. Program Details Program Eligibility Graduation / Post Graduation Medical professionals, Allopathic, Homeo and Ayurvedic Doctors Working professionals in the field of MLT, Medical writing, Medical Transcription

22. Admission Procedure Submission of Application Form along with the demand draft of Rs. 300 /- in favor of Bioinformatics Institute of India, payable at Delhi / Noida. Enclosures (Marksheet – 10 th , 10+2, graduation / Post –graduation 2 Photographs 3 Self addressed envelopes) Personal & Telephonic Interview

23. Program Faculty / Team Dr.Kumud Sarin Ph.D Dr.Anirban Das Ph.D Mr.G.K.Srivastava Clinical Trial Specialist Mr.Jitendra Chaudhary MBA Ms.Charu Agarwal MBA Ms.Shikha Kaushik B.Pharma

24. BII Courseware

26. Program Curriculum Module –I Clinical Trials and Clinical Trials Environment Module-IV Contract Research Module-II Statistics for Clinical Trials Module-V Regulatory Affairs, GCP, Pharmacovigilance and Ethics Module-III Clinical Data Management Module-VI Practical Medical Writing and Documentation Module-VII Research Study

27. Program Award After completion of the Program the participant will be provided with the following certificate (Sample)

28. Thank You For Further Details & Enquiries Contact: Bioinformatics Institute of India C-56A / 28, Sector – 62 Noida – 2010301, U.P Tel: 0120-4320801/02 Mobile: 9818473366, 9810535368 Email: info@bii.in Visit: www.bii.in