Clinical trials help doctors understand how to treat a particular disease or condition. It may benefit you, or others like you, in the future.
Non biologics - Development costs and timelines Opportunities and Challenges with Biologics Clinical Development of Biologics — how is it different? New clinical trials rules and its impact Current requirements of Indian Clinical Trial Application CTA and how this will change with the new clinical trial regulation Substantial amendments and non-substantial amendments Ethical considerations for clinical trials performed in children guideline compared with adults Influencing the best strategy for the different regulations across India and globally Key development for sponsors and investigators to insure if they meet regulatory necessities when performing multi-country clinical trials Conducting direct-to-patient trials using technologies, such as apps and wearables to report data and analyse current strategies and relevant regulations Assuring the efficacy and success of clinical trials — What is a best practice for working with regulatory agencies?
Promoted as Joint Commissioner in March Expert in Detection and investigation of various cases related to spurious drugs and other violations of Drugs and Cosmetics Act. He began his career as a lecturer at J. College of Pharmacy, Ooty. He was awarded as "Best Drugs Inspector" in the year He has made remarkable contributions in National and International seminars, workshops, which shows his urge for upgrading knowledge of the complex pharma spectrum which undergo rapid changes.
Mayur Parmar is working as Deputy collector with Govt of Gujarat. He is carrying six years of rich experience and during his tenure he has inspected various Drug manufacturing sites, drugs Distribution sites, hospitals, blood banks and blood storage centres as per Indian as well as WHO guidelines.
With six years of experience of Drug Regulation, Mayur has investigated more than NSQ drugs and launched Prosecution for spurious and misbranded drugs. Prior to it Mayur has completed his M. Pharm with specialization in New Drug Delivery System from Maharaja Sayajirao university of Baroda, Gujarat with two gold medals for securing first rank in the university.
He has published four research papers in International and National journals.
His views on Pharma regulations have been published in various magazines like eHealth and others. He is pursuing his Ph.
D in New Drug Delivery System. He has chaired two international conferences and speaked at various national and international forums. He is having industrial experience in formulation development and Intellectual property management.
A Huge believer of lifetime learning - Mayur constantly strives to improve himself, both on personal and professional front. He has managed clinical development of novel molecular entities in diverse therapeutic areas in all clinical development phases.
Dr Bhatt has worked as a consultant in pharmaceutical medicine and clinical pharmacology. Dr Bhatt is the recipient of Drug Information Association outstanding Service award for his immense contributions in his field of specialization.Steven Piantadosi, MD, PhD, is the Phase One Foundation Distinguished Chair and Director of the Samuel Oschin Cancer Institute, and Professor of Medicine at Cedars-Sinai Medical Center in Los Angeles, California.
Dr. Piantadosi is one of the world's leading experts in the design and analysis of clinical trials for cancer research.
Jan 04, · Designing Clinical Trials. Researchers design clinical trials to answer specific research questions related to a medical product. These trials follow a specific study plan, called a protocol, that is developed by the researcher or manufacturer.
Before a clinical trial begins, researchers review prior information about the drug to develop research questions and objectives.
Tags: Clinical Development, Clinical Trial Results, Pharmacokinetics, Pretomanid/PA, TB-HIV Four-Month Moxifloxacin-Based Regimens for Drug-Sensitive Tuberculosis Publication: Gillespie SH, Crook AM, McHugh TD, et.
al. The variations in regulatory understanding have confounded many stakeholders. In order to find a practical way forward, industry and professional associations should concentrate efforts on identifying and addressing concerns around clinical data quality.
The position proposed by the members of the WHO Registry Platform Working Group on the Reporting of Findings of Clinical Trials is that “the findings of all clinical trials must be made publicly available”. This paper discusses the principles underlying this position.
The following PDF documents consist of a variety of clinical studies and independent research reports on the antimicrobial qualities of colloidal silver-related products including silver ions, silver compounds, silver nanoparticles, nanosilver compounds, silver-impregnated and silver-coated products, and many other forms of silver being used in.