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

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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)

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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)

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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

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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.