AU-KBC Research Centre,
Anna University, Chennai.
Announce a 1 month Training Programme on
Advanced Certificate Course in Clinical Data Management (CDM) and Pharmacovigilance (PV)-(ACC CDMPV) -Full Time
4th April-3rd May, 2016 Chennai.
Clinical Data Management (CDM) is an important phase in clinical research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials.CDM assures collection, integration and availability of data at appropriate quality and cost. Clinical Data Management supports the conduct, management and analysis of studies across the spectrum of clinical research. Pharmacovigilance (PV) is also known as Drug Safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products. As such, pharmacovigilance mainly focuses on adverse drug reactions (ADRs), which are defined as any response to a drug which is noxious and unintended, including lack of efficacy
The Primary aim and scope of the course is to make the candidates employable as Manager, Medical Advisor, Pharmacovigilance Specialist/Expert/Scientist, CDM Specialist, CDM Data Analyst, Clinical Data Coordinator, Clinical Data Manager, etc in BPOs, Pharmaceutical companies, Contract Research Organizations (CROs),Support Staffs for Clinical Data Management and Biostatistics services to various clients involved with Clinical Research etc. The Program also serves as a sound introduction to CDM and PV domain for other potential players in the industry such as medical practitioners, pharmaceutical scientists etc.
The Program is for One Month Duration, Full Time and consisting of 120 contact hours. This unique combination of sound Theoretical and strong Practical training at Anna University ensures the employability of the candidate immediately on completion of the Program. Other than AU-KBC Research Center and Anna University, Chennai the course Faculties are drawn from the IT companies, reputed Hospitals, Contract Research Organizations, Site Management Organizations, Research Laboratories & Institutes, Universities, Medical Colleges, Pharmaceutical companies, etc., in and around Chennai.
PROGRAM COVERAGE
The program contents would be covered in one-month duration as two parts.
1. Clinical Data Management (CDM)
2. Pharmacovigilance (PV)
The Program would cover the following areas:
Drug Discovery and Development-Overview
- Drug Discovery Process including stages of Basic Research, Drug Development which involves Pre-Clinical Testing, Clinical Research, Registration with the Drug Regulatory Agencies and finally introduction of the Drug to the public after the due Approvals, etc.
Clinical Data Management
- Data Management Plan
- Clinical Data Management System
- Clinical data repositories
- Loading of external data into CDM system
- Query management
- Data Clarification form
- Remote data entry
- Clinical data entry-single, double entry, SAE reconciliation, Coding of adverse events
- Data cleaning and Data validation (using SAS Software) (working with missing values, outliers start and end dates, system validation).
- E-CRF designing, data tracking
- Data base locking
- Clinical data archiving
- CDM SLA
Pharmacovigilance
- General Overview
- Key terms & Terminologies
- Gen. & Sys. Prin. Of PV
- SOPs in PV
- Regulatory guidelines & laws in PV
- ISCR
- Med. Dic. for drug regulatory activities - MedDRA
- Diag. & Mang. of Adverse drug Reactions
- AE/ADR reporting sys. & forms
- Causality Assessment
- Narrative writing
- Expedited Reporting requirements
- PSURs for marketed drugs
- Signal Detection Tools
- Risk assessment, evaluation & Management
- Quality sys. In PV
- Eudravigilance
- PvPI (National Pharmacovigilance Protocol)
- PV Database and other PVG software
- Additionally IT skill development, Periodic Communication and Personality Development sessions will be conducted.
ADMINISTRATION
The program would be offered by the "Bioinformatics and Clinical Research" Group of the AU-KBC Research Centre, and the Program Coordinator Dr. G. Ramesh Kumar would have the overall Administrative responsibility for its conduct. There would be a Faculty Committee (FC) consisting of experts who would be teaching the different topics and who would review the progress periodically. At the end of the program, candidates who have successfully completed the program, as well as paid the full fees, would be issued a certificate signed by representatives of AU-KBC Research Centre that would also reflect the level of performance of the candidates.
ELIGIBILITY AND FEES
B. Pharm / M. Pharm.
M. Sc in Chemical / Biological Sciences.
B. Tech / M. Tech Biotechnology.
M.B.B.S. / B.D.S.
B. V. Sc
B. Sc. Allied Health Sciences.
Degrees in Alternate Systems of Medicine
Graduates in Para Medical Branches
Other equivalent Qualifications as approved by the authority.
Admission will be based on Interview held at the AU-KBC Centre.
The Course has a fees of Rs.19, 950/- (including Service Tax), to be paid in full before the commencement of classes. Course Certificates would be issued to candidates only on satisfactory completion of the entire course requirements as well as on full payment of the fees.
All aspects of the program have been designed keeping in mind the employability of the candidates immediately on completion of the Course. While the organizers and their institutions take no responsibility as such for the placement of the trainees, they would provide active assistance and help to the successful candidates in finding a suitable placement at the end of the program.
ADMISSION
Admission will be based on interview only and there is no written test.
Candidates are instructed to bring all final year copy of their UG/PG Certificates.
HOW TO APPLY
Download the Application form here and send the same duly filled to The Director, AU-KBC Research Centre, Anna University, M.I.T Campus, Chromepet, Chennai - 600 044 along with a Demand Draft for Rs.500 (Five Hundred Rupees Only) drawn in favour of The Director, AU-KBC Research Centre payable at Chennai.
Application Closing Date: 24th of March,2016
If any candidate is found not to meet the required eligibility criterion, or indulge in any form of malpractice, he/she will not be permitted to proceed further with the admission process.
CONTACT PERSON
Dr. G. Ramesh Kumar,
Course Coordinator, AU-KBC Research Centre,
MIT Campus,Anna University Chennai,Chromepet,
Chennai - 600 044.
Tel: 91-44-22232711 Extn.133,
E-mail: ctm@au-kbc.org
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