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Workshop on
Advanced Good Clinical Practice
| Date: 15-05-2009 Friday | Time: 09.00. AM to 5.30 PM |
MakroCare recognizes the need to continuously educate Clinical Research and Medical professionals in the field of clinical research. The theme of this workshop is to impart important information about advance areas in Good Clinical Practice to the medical/clinical community.
Our goal is to enhance the practical ability and to perform quality clinical research in accordance with the existing ICH-GCP regulations and guidelines among the participants. This is accomplished through lectures and practical presentations of information facilitated by MakroCare. Experienced professionals from well-known pharmaceutical and healthcare industry will present their topics and discuss the practical challenges and their advices/solutions for GCP in practical implementation in clinical Research.
- Relevant portions of GCP guidelines according to the requirements
- The legal aspects of clinical trials
- The need for and the procedures to be adopted for safeguarding the rights, safety, and wellbeing of subjects participating in clinical trials
- The importance of documentation before, during, and after a clinical trial
- To conduct a clinical trial ethically
- Management of risk during a clinical trial
- Be ready for audits and inspections
- Be able to write impeccable standard operating procedures (SOPs) for an Investigator
- The concepts of professional project management so as to be able to improve quality and conduct a clinical trial more efficiently
Dr.B.Shiva Naga Vara Prasad, Sr. Manager-Clinical QA, MakroCare
May 15th, 2009 - 09:00 to 5:30 PM
Registration starts at: 08:30 AM
Lunch & Cultural program
All documentation and refreshments are included
CHITRAMAYEE Auditorium,
State Arts Gallery, Kavuri Hills,
Madhapur, Hyderabad - 33 .
(1/2 km from Madhapur police station)
Physicians, Investigators, Clinical Quality Assurance, Clinical Research Associates, Project Managers, and Clinical Professionals in Clinical / Healthcare / Pharmaceutical / Biotech industry professionals.
Internet : Click Here
Phone : +91 40 44346688
Email : gcpworkshop@makrocare.com
Registration Fee : None (Free)
SELECTED PARTICIPANTS WILL BE INFORMED OVER PHONE OR EMAIL
Point of Contact:
Name : Helpdesk
Contact No. : +91 40 44346688
Email id. : gcpworkshop@makrocare.com
MakroCare, a global clinical services firm, provides clinical research support to pharmaceutical, biotechnology, and medical device industries. The company offers site selection, patient recruitment, project and data management, clinical monitoring, medical writing, PMS / Pharmacovigilance, biometrics, regulatory assistance, and quality assurance. MakroCare has offices in India (Hyderabad), Japan (Tokyo), USA (New Jersey, Illinois, Pennsylvania), and Germany (Frankfurt).
MakroCare, Hyderabad
+91 40 44346666 Extn.408