Regulatory and Ethical Issues in Pediatric Clinical Research: Recommendations From a Panel Discussion

Author:

Kshirsagar Nilima1,Swaminathan Soumya2,Jog Pramod3,Dalwai Samir4,Mathur Roli5,Shekhar Chandra5,Meibohm Bernd6,Gupta Y. K.7,Shafiq Nusrat8,Sunkara Gangadhar9,Somani V. G.10,Kulkarni Prasad11,Tseng Brian12,Mehta Dhvani13

Affiliation:

1. President, South Asian Affiliate of ACCP, National Chair in Clinical Pharmacology; Indian Council of Medical Research; Delhi India

2. Indian Council of Medical Research and Department of Health Research; Delhi India

3. Indian Academy of Pediatrics; Mumbai India

4. New Horizons Child Developmental Center and Research Foundation; Neuro Developmental Clinic, Lokmanya Tilak, Municipal General (Sion) Hospital and Medical College; Mumbai India

5. Indian Council of Medical Research; Mumbai India

6. American College of Clinical Pharmacology, Department of Pharmaceutical Sciences, and Research and Graduate Programs, College of Pharmacy, The University of Tennessee Health Science Center; Memphis TN USA

7. Department of Pharmacology and All India Institute of Medical Sciences; New Delhi India

8. Department of Pharmacology; PGIMER; Chandigarh India

9. Novartis Institute for Biomedical Research; Cambridge MA USA

10. Joint Drugs Controller of India; Government of India New Delhi India

11. Serum Institute of India Pvt Ltd; Pune India

12. Pediatric Therapeutic Area in Clinical Development, Novartis; Cambridge MA USA

13. Vidhi Centre for Legal Policy; New Delhi India

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

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