Unacceptable or offers not in compliance with solicitation Comptroller General - Key Excerpts New First, as noted above, the RFP detailed specific requirements for the documentation in proposal volume VI, which included the cover letter and SF With respect to the offeror's cover letter, the RFP required that the letter "[a]ddresses compliance to all RFP requirements and instructions to include any exceptions to the Terms and Conditions of the solicitation [and be] signed by an officer of the Offeror that is authorized to bind the Offeror's company.
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.
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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. Dr Bhatt has more than publications in national and international journals. In this role, he is responsible for managing scientific and medical affairs for the regions of Asia, Latin America, Africa, Middle East and Eurasia.What is open-ended play?
Children are naturally curious and explore the world around them through play experiences. Open-ended play can be described as play that has no pre-determined limitations and no fixed answer – children simply follow their imagination to allow the play to go in any.
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