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CDSA Newsletter
Clinical Development Services Agency
Dear Reader,
The monsoon season has arrived and here is the next issue of
2016 series of Quarterly CDSA Newsletter. CDSA has a lean
team of responsible members with defined and balanced roles
and responsibilities. Together we all are working as a team to
get incredible results and achieve our organizational mandate. A
team is a primary building block of an organisation. The ability
to pull together, resources to accomplish tasks faster and the
cultivation of rewarding interpersonal relationships, is what we
call “Teamwork”. Team leaders should never forget that the key
to have a successful team is the individual strengths of its
members and particularly blend of different strengths which
makes a team really effective. This all creates a synergy among
individuals, which can drive high performance and successful
attainment of team goals. Becoming skilled at doing more with
others may be the single most important thing one can do to
increase her/his value regardless of her/his level of authority.
Happy Working towards your organizations’ goals to
accomplish your success stories!!
I S S U E 6 J U L Y 2 0 1 6
Editor Dr. Sudhanshu Vrati Sub Editor Dr. Pawandeep Kaur Dhawan
CONTACT US
NCR Biotech Science Cluster
3rd Milestone, Gurgaon -Faridabad
Expressway,
Faridabad-121001, INDIA
Email: cdsainfo@thsti.res.in
Websites: cdsaindia.in; cidp.in
I S S U E 6 J U L Y 2 0 1 6
2
Training Programs
Inauguration of Workshop on Laboratory Quality
Management System in Biotherapeutics at NIB by
Dr. G. N. Singh (DCGI, CDSCO), Dr. Surinder
Singh & Dr. Renu Jain (NIB), Shri. D. S. Tewari
(Ex-Director, NABL), Dr. T. S. Rao (Sr. Adviser,
DBT) & Dr. Sucheta B Kurundkar, CDSA (May 17-
19, 2016)
Blue and Green Book written by NIB Scientists & CDSA
released by Dr. G. N. Singh (DCGI, CDSCO) and Shri.
D. S. Tewari (Former NABL Director & Head, GLP
CMA)
I wish to thank you for very well planned and well
executed workshop. You won’t believe in my life time this
is the first workshop where I had slogged till 11.30 pm.
But it was worth doing the home work. Dr. P. S. Shah, NIV, Pune, Participant, National
Workshop on LQMS in Biotherapeutics (May 17-19,
2016), NIB, Noida
Thank you for organizing a very informative course at
Tata Medical Center, Kolkata. Really looking forward to
working with you again very soon. Dr. Sanjoy Chatterjee, Sr. Consultant, Clinical
Oncologist & Member Secretary, IRB, Tata Medical
Center, Kolkata
It was indeed a pleasure attending the workshop. I learned
and enjoyed the whole scheduled activities of the
workshop. Now I can say it was really a "Happy
Learning". Thank you very much. I again thank you for
giving me the opportunity to attend the workshop. I look
forward to other workshops you are planning to organize
in near future so that I can learn and contribute in
improvement of the quality in my organization. Dr. S.A. Ansari, Assistant General Manager
(Projects), Bharat Immunologicals & Biologicals
Corporation Ltd. (BIBCOL)
Current Ethical & Regulatory Requirements for
Clinical Trials (An Awareness Program) at Tata
Medical Centre, Kolkata (Apr 27, 2016)
Requirements for Members of Ethics Committee (An
Awareness Program) at Centre for Health Research &
Development – Society for Applied Studies (CHRD-
SAS), New Delhi (May 29, 2016)
Good Clinical Practice (An Awareness Program) at
Tata Medical Center, Kolkata (Apr 28, 2016)
I S S U E 6 J U L Y 2 0 1 6
3
Research Methodology at ANIIMS,
Port Blair (May 07-08, 2016) inaugurated by Chief Secretary, Shri A.
Majumdar and Principal Secretary
(Health) Shri. A. Baroka, Andaman & Nicobar Administration
CDSA in News
CDSA conducted three Programs at ANIIMS, Port Blair, Andaman & Nicobar Islands.
Current Ethical & Regulatory Requirements
for Clinical Trials / Research (An Awareness
Program) at ANIIMS, Port Blair (May 10,
2016)
Good Clinical Practice (An Awareness Program) at
ANIIMS, Port Blair (May 09, 2016)
I S S U E 6 J U L Y 2 0 1 6
4
Maternal and Infant Sciences: A Grand Challenge Programme on Preterm Birth
After a series of national and international consultations, the Department of Biotechnology (DBT),
Ministry of Science and Technology, Government of India has launched a major national programme
"Maternal and Infant Sciences: A Grand Challenge Programme on Preterm Birth” to identify the
correlates, causes and predictive biomarkers of preterm birth under its Grand Challenge Programme.
Because of the multifactorial nature of preterm birth, scientific expertise from multiple domains of
clinical, biological and statistical sciences are required. Therefore, cross-disciplinary platform is being
used to bridge expertise from disparate fields, such as, paediatrics, gynaecology, infectious disease
biology, epidemiology, microbiology, immunology, cellular & molecular biology, genetics, statistics and
computational & systems biology.
Research Teams involved are Paediatric Biology Centre (coordinator of the program), Centre for Human
Microbial Ecology (Microbiome Analyses) and Clinical Development Services Agency (Quality
Management) from Translational Health Science and Technology Institute (THSTI), Faridabad;
Gurgaon Civil Hospital (Study Site); Safdarjung Hospital (Referral Hospital); National Institute of
Biomedical Genomics (Genomic and Epigenomic Assays); Regional Centre for Biotechnology
(Proteomic Analysis); Maulana Azad Medical College and All India Institute of Medical Sciences
(Scientific and Technical Guidance). In addition to these institutions, the Health Department, Govt. of
Haryana, Tata Consultancy Services, Department of Health Research and the Indian Council of Medical
Research are also actively involved.
Investigators’ Meeting - Verapamil Dose finding
Study in Adult Patients with Tuberculosis
CDSA is coordinating a phase 2 dose range finding
study of Verapamil in adult patients of pulmonary
tuberculosis. The study is sponsored by National
Institute for Research in Tuberculosis (NIRT),
Chennai with funding from DBT. The
Investigator’s meeting for the study was held on
13th June 2016 at National Institute of Tuberculosis
& Respiratory Diseases, New Delhi
Principal Investigator and Co-Investigators of
National Institute of Tuberculosis & Respiratory
Diseases, New Delhi
5
I S S U E 6 J U L Y 2 0 1 6
Employees’ Corner
CDSA bid farewell to Jasmine Sharon Luke,
Medical Writer Level-I
Upcoming Events Sr. No. Dates Training Title Venue
1 Jul 26, 2016 Good Clinical Practice (An Awareness
Program)
THSTI, Faridabad
2 Aug 10-11, 2016 Good Clinical Practice (GCP) & Good
Participatory Practice (GPP) (An Awareness Program)
KIMSU, Karad
3 Sept 14-15, 2016 Awareness Program on Good Clinical Practice (GCP) Requirements for Potential
Clinical Research Professionals
Assam Medical College & Hospital, Dibrugarh
4 Sept 27, 2016 Good Clinical Practice (An Awareness
Program)
IISER, Pune
5 Sept 28, 2016 Current Regulatory Requirements for the
Members of Institutional Ethics Committee Program (An Awareness Program)
IISER, Pune
6 Sept 29, 2016 Current Regulation on Medical Devices and in vitro Diagnostics (IVD) Kits
NCL-VC, Pune
7 Oct 18-21, 2016 Training Course on Basics of Good Laboratory Practice (GLP)
Assam Medical College & Hospital, Dibrugarh
CDSA welcomes Dr. Ramu Adela (Research Officer, Verapamil Study) and Ranjan Kumar (Study Monitor,
GLSE) as a new addition to CDSA family
Biostatistics Department of CDSA has initiated organization of Webinars. The first webinar was conducted on April 11, 2016 by Dr. Gayatri Vishwakarma on “Study Designs in Clinical Research”. Eighteen
Investigators participated across the nation. CDSA is committed to organizing webinars in future on various topics related to clinical research.
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