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Dr. Renu Razdan, Chief Working Officer, Max Neeman Worldwide
Conducting medical trials in India is engaging due to a vibrant city well being care atmosphere, English because the enterprise language, first price medical credentials of CRAs and Challenge Managers, and a big therapeutically numerous affected person inhabitants.
Regulatory our bodies in India made strides final 12 months strengthening drug /gadget laws and medical trial legal guidelines gaining in affected person safety whereas growing alignment with western regulatory authorities. Lots of the modifications have captured media consideration and raised questions.
Be a part of Dr. Razdan for a stay dialogue to be taught concerning the many points concerned in conducting medical trials in India together with:
The present medical trial regulatory situation
How the developments are optimistic since crucial issues of SAE compensation have been addressed and focused timelines issued
How guidelines are being streamlined for conducting medical trials in India to supply greater transparency amongst all stakeholder teams together with sufferers, trade, sponsor and regulators alike
India’s regulatory authorities proceed to be dedicated to progressive assessment and approval of international medical analysis requests, having discovered from and improved upon strategies to make sure moral, ICH GCP conduct. Dr. Razdan and Max Neeman Worldwide have labored intently with the Drug Controller Basic of India [DCGI] since 2001. Throughout this presentation, Dr. Razdan may even focus on:
Focused approval timelines issued by DCGI
Regulatory companies accountable for trial approval
SAE Compensation necessities
Processing of Import / Export License
DCGI assurances for moral and ICH GCP conduct by all websites
Why conducting medical trials in India nonetheless is sensible for world research
Key phrases: medical trials in india, approval course of