The Ministry of Health and Family Healthcare has taken some important steps recently for streamlining the conduct of clinical research in India, and for safeguarding the rights and well – being of research participants through changes in the Drugs & Cosmetics (D&C) Act, 1945 with respect to analysing the reports of serious adverse events occurring during clinical trials and procedures for payment of compensation; specifying authority for conducting clinical trial inspections and actions in case of non-compliance; and making it mandatory for all Ethics Committees to be registered with DCGI prior to considering any proposal for review.
These changes have a huge impact on the way clinical research has been conducted in India till now, and all the stakeholders of clinical research industry currently are experiencing a whirlpool of queries and concerns about the practical implementation of these changes.
A need is thus felt for deliberations and training on these topics. With this objective, a workshop has been planned by Auriga Research Ltd. and SenseCR in collaboration with Jamia Hamdard (Hamdard University), to have live discussion on all the changes as per new amendments along with case studies and discussion on various scenarios for better understanding. Eminent speakers from academia and industry will be interacting with the participants.
While the Drug Controller General of India (DCGI) will be the keynote speaker, Dr G N Qazi, vice chancellor, Jamia Hamdard will be inaugurating the workshop. All the stakeholders in clinical research industry including sponsors, CROs, SMOs, hospitals, teaching institutions, insurance companies and pharmacovigilance units will be benefited by this workshop.
For registration enquiries, contact the organizing team at: training@sensecr.com/ nishant@aurigaresearch.com/ nidhiagarwal@jamiahamdard.ac.in, or call the organising team at +91 22 2353 5233 / +919540930950 / +919818334770.