Reserve your spot now!
Wednesday, April 2, 2014
3:00 PM IST
Regulatory requirements for conducting clinical trials in India have rapidly evolved and become very stringent with the introduction various requirements such as SAEs reporting timelines, compensation guideline, and mandatory audio-video recording of consent for all clinical trials.
Sponsors, investigators, CROs and all stakeholders need to understand these recent requirements and ensure compliance to these requirements.
In this webinar we will be covering all the recent regulations introduced in along with necessary requirements for successful submission or a clinical trial application.
We will also be sharing our experience and learning from presentations given atNDAC meetings to help you be better prepared for NDAC presentations.
|Topics which will be covered in the webinar|
|Dr. Khalid Khan,
Director, Fermish Clinical Research Pvt. Ltd. and
Leading Regulatory Consultant
PresenterDr. Manoj Karwa,
Head-PPM, Auriga Research Ltd.
Managing Director, Auriga Research Ltd.
About the Presenter:
Dr. Khalid Khan had been working as a pharmaceutical consultant since 1993 and is well known among the Indian Pharmaceutical Industry as a hardcore, sincere and honest professional in the area of regulatory affairs and clinical research and strategic alliance. Professionally Dr. Khan is post graduate pharmacologist from University of Delhi and completed his Doctorate in Pharmaceutical Sciences with a subject titled “Comparative Studies of Regulatory Systems with regards to new drug approval between India and Developed Countries”. Dr. Khan is now heading his own two companies Fermish Clinical Technologies Pvt. Ltd., and Kleward Consulting Pvt. Ltd., which provides niche services to respected Pharmaceutical/medical device companies and Clinical Research Organizations including Data Management Centers.
He has experience of handling number of new drugs and clinical trials application for all categories of products like drug, medical device, biological, cosmetic etc. Dr Khalid Khan has experience of handling GMP & GCP audits and also imparted training on regulation in country on different platforms.
Dr. Manoj Karwa
He is Head- Project Planning and Management at Auriga Research Ltd, a CRO based in Delhi. He has done masters in pharmacology from NIPER, Mohali and doctorate in management from IBME, Delhi. He has overall managed more than 150 protocol writing and 70 BA/BE studies for submission to different regulatory authorities. He has managed all phases of clinical trials for drug, medical device, vaccine, cosmetic and herbal products. He has organized three training events in collaboration with Jamia Hamdard, Tata Memorial Hospital and Rajiv Gandhi Cancer Research Institute. These training events were focused on recent clinical trial regulations with special emphasis to preparedness for clinical trial sites. He has more than 10 international articles and posters in recognized journals and conferences respectively. He has also authored free e-learning courses on BA/BE studies, Clinical trials and Indian Regulatory System.
Dr. Saurabh Arora:
Dr. Saurabh Arora is graduates from NIPER and doctorate from Jamia Hamdard in drug delivery. He is director Arbro Pharmaceuticals Ltd and Managing Director and founder of Auriga Research Ltd. He is guiding force for team of 500 professionals and serving industry by offering services in sector of formulation, analytical and clinical development. Because of his inherent interest in sharing knowledge and ongoing education, he initiated Lab-Training.complatform for imparting training on analytical techniques and FoodSafetyHelpline.com for imparting training on food registration &licensing. He has numerous publications in national and international peer reviewed journals, conference presentations and has been the speaker at a number of conferences. He also has 2 Indian and 1 US patent to his credit.
You can attend the webinar live and also get access to the webinar recording for a low fee of Rs. 499 INR. Registered participants will be sent a payment link on successful registration for the webinar after providing necessary details using the link below :https://attendee.gotowebinar.com/register/2375365486481631746