Clinical Trials Training : Derex Labs Pvt Ltd Hyderabad

[Derex Labs]

ICH-GCP Practical Training

Module I:
a) Overview of Clinical Research Industry
b) Medical Terminology and Overview of Systems
c) CRO and CMO

Module II:
a) Overview of GCP/FDA/EU/Indian Guidelines
b) ICH-GCP E6 Guidelines
c) Schedule Y
d) Ethical guidelines for Biomedical Research on Human Participants (ICMR)
e) CDSCO Guidelines
f) 21 CFR 50, 54, 56,312
g) Declaration of Helsinki
h) Guidance and General Considerations in CR (E8)
i) Clinical Safety Data Management (E2A)
j) HIPPA

Module III
a) History of CR
b) Evolution of Ethics in CR
c) Ethics in CR
d) ICF Preparation and Administration
e) Financial Disclosure, Form 1572, PI Undertaking
f) Protocol and IB in CR
g) Case Report Form (CFR) in CR
h) SOP

Module IV
a) Basics of PhV (pharmaco Vigilance)
b) Basics of Data Management in CR
c) QA in CR
d) Contracts in CR
e) Project Management CR
f) Subject retention and Recruitment in CR
g) Misconduct and Fraud in ClinicalResearch
h) Preparation of Budget in CR

Module V
a) Job Level skill Task 9 for CRA)
b) Prequalification Visit
c) Investigator meeting in CR
d) Site Initiation Visit
e) Periodic Monitoring Visit
f) Collection and review of Regulatory Document
g) Handling Audits and Inspections
h) IP Management in CR
i) Site Closeout & archival
j) Samples Forms and Templates
k) Query resolution/ SAE reconciliation

Module VI
a) Professional Development
b) Communication skills
c) Working in Teams& conflict Resolution


Duration of the Course: 6 Weeks (Saturday 8 Hrs, Sunday 4 Hrs)
Fee: Rs 15,000
Live Projects Available
New Batch Starting on 18-04-09

For Further details Contact:

Gopala Krishna
Managing Director
Derex Labs Pvt.Ltd
2/A, MIG Colony
Above Corporation Bank,
Beside S.R.Nagar Community Hall
S.R.Nagar
Hyderabad-500 038
Ph: 040-64508894,9246804891
Mail: derexlabs@gmail.com
URL; http://derexlabs.tripod.com

[Guest-IJT]

Name : sunil
Email : meetssunil AT gmail.com
Designation / Skillset : engg.
resumwe

Resume :

Career Objective :
To work with a reputed organization to use my technical skills for the benefit of my self as well as that of the organization.

Professional Qualification :
- B-TECH in MECHANICAL ENGINEERING(fresher) from Kurukshetra University, Kurukshetra at N.C. College of Engg., Israna with aggregate 70% marks
Academic Qualification :
- 12th from S.D. Senior Secondary School, Panipat, Securing 69%
- 10th from C.R. High School, Panipat Securing 67%.
Strengths :
- Sincere and cooperative.
- Hardworking and Punctual.
- Good communication skills.
- Team spirit.
- Socially Adjustable.
- Very Disciplined and Responsible.
Equipped with computer basics, internet & MS-OFFICE
Interest & Spare Time Activities
- Reading newspaper.
- Listening music.
- Watching & Playing cricket.
- Net surfing
Area of interest :-
- Production, quality control, inspection, manufacturing, maintenance etc.
Summer Trainings/projects :
- Summer Training :
6-WEEK training after 2nd year at Tool Room Training Center, Delhi

6-WEEK training after 3rd year at Sun Beam Auto Limited, Gurgaon(haryana)
- Projects :
Minor Project on “GEOMETRY OF DRILLING BIT”.
Major project on “SOLAR JACK”


Declaration :
I hereby declare that the information furnished above is true to the best of my knowledge and belief.
Date : 05 July, 2011
Place : PANIPAT (SUNIL KUMAR)

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Submission ID : 4332492
Date & Time : 5th Jul 2011 12:27 PM (UTC)
IP Address : 120.56.152.231
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Predicted Country []: India

[Guest]

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Involves and takes you through Clinical research, CDM, SAS, internship on clinical trial, imaging trial management. It’s a 170 days program. Highly experienced staff from abroad and India trains you with hands of experience on various areas in clinical research, Pharmacovigilance, Drug regulatory affairs, imaging analysis etc. You may have chance getting absorbed in company projects itself. For any details