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Our Team

Dr. Monika Bahl, MBBS, MBA, Director Clinical Portfolio Management

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Dr. Monika has joined CDSA as the Director Clinical Portfolio Management. A graduate in medicine with additional specialization in human resource management, she brings with her over 16 years of experience in clinical practice and clinical research including project planning, clinical monitoring and project management for in-house and outsourced clinical research projects. She has substantial experience of managing projects in varied therapeutic indications including immunology, pain management, cardiovascular, respiratory, dermatology, psychiatry and diabetes mellitus in previous assignments in Indian and global pharmaceutical / Biotech industry (Ranbaxy Research Laboratories, Dabur Research Foundation, Panacea Biotec, Quintiles).  

She has been associated with clinical studies in paediatric, adult and geriatric populations including mega-trials for DCGI/FDA/BfArM submissions. Her responsibilities have spanned from project planning, protocol designing, CRO selection and project management for the full duration of studies from pre-trial to project close-out, medical monitoring, data review and related medical writing. She has significantly contributed to training and mentoring programs for performance improvement and for quality management initiatives on individual, project and organizational level.

Dr. Sucheta Banerjee Kurundkar, PhD (Biochemistry), MBA, Director Training

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Sucheta Banerjee Kurundkar has joined CDSA as Director Training in 2012. She has 20+ years of experience in research and CRO Industry. Prior to this, she was Chief Scientific Officer at a multinational Clinical Research Organization (CRO). Her area of interest apart from training is in regulatory affairs, quality assurance in pre-clinical, clinical & medical laboratories. She is a GLP Trainer (WHO), GCP Trainer, Auditor for NABL (ISO 15189, ISO 17025), ISO 9001:2015 and NABH standards. She is a NABH Assessor (Ethics Committee under clinical trial accreditation program). Sucheta is a Visiting Faculty to Bureau of Indian Standards & National Institute of Training for Standardization. Sucheta obtained her PhD in Biochemistry from University of Pune. Her doctoral work on a novel inhibitor received recognition at the World Congress on Insulin Resistance Diabetes & Cardiovascular Research, USA (2010). She is the recipient of CSIR International Travel Award. She has a MBA with specialization in Total Quality Management from Sikkim Manipal University and Management Development Programme from IIM, Ahmedabad (IIMA). She is an International Program Committee member of IIMA (2015-till date). Professionally trained in ‘Management of Training’ from Institute of Secretariat Training and Management, she has steered >100 training programs across 50+ Indian cities covering >10000 participants, >2000 institutions at CDSA. She is a reviewer to eleven international journals of repute. Sucheta is working to make e-learning programs on regulations, GCP and ethics. She is an Advisory Group Member to WHO-ICMR-NIE e-course for Indian Ethics Committees (e4IEC).

Prashant Bhujbal, Finance Manager

http://www.cdsaindia.in/sites/default/files/prashant.pngMr.Prashant Bhujbal has joined CDSA as Finance Manager. He did MBA in Finance and also holds a post graduate degree in Agriculture. He has worked for more than 23 years in the Maharashtra Finance and Account Cadre under Government of Maharashtra. As a member of finance Cadre he served on diverse postings in various Government departments ranging from Account, Audit and Procurement of Goods.

 

 

Arun Kumar B. Ramteke, Consultant, Regulatory Affairs

http://www.cdsaindia.in/sites/default/files/arunm.pngMr. Ramteke retired as a senior drug regulatory officer with 31 years of experience in drug regulatory aspects in the office of the Drugs Controller General of India (DCGI). He has in-depth knowledge of Indian Drugs & Cosmetics Act, Rules and of regulations of Global Drug Regulatory norms. He started his career at Central Research Institute Kasauli in biological-drug testing. He has extensive experience with new drugs, vaccines and biotech products/pharmaceuticals, medical devices approvals and development experience. He also has experience in review and evaluation of product dossier for pre-clinical, toxicological, pharmacological, CMC, and quality control, clinical trial data of new drugs, biological and medical devices (INDs, ANDAs).

He has strong skills in quality assurance management, regulatory oversight of clinical trials, development of SOPs and guidelines and involvement in drug rules amendments. As an expert he has attended various national and international training workshops and meetings on drug regulations. He has contributed to preparation and implementation of Good Clinical Practices (GCP), Good Laboratory Practices (GLP) and Good Manufacturing Practices. He works as an Expert to the Pharmacovigilance Program, GCP Training and Inspections of CROs in India.