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

Affiliations

• 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.