Webinar On 10 Steps to an FDA-Acceptable Clinica

1. ContactUs:416-915-4458 WeEmpower,YouComply! Webinar On 10 Steps to an FDA-Acceptable Clinical Trial Protocol Toregisterforthiswebinarpleasevisitourwebsitewww.compliancetrainings.com Webinar Description: If you are involved in writing a clinical trial protocol, this seminar will provide valuable suggestions about various aspects of a clinical protocol from initial synopsis to various elements of the protocol, role of various personnel in finalizing the protocol, and troubleshooting common issues. The basic elements of a clinical trial protocol, the dos and don’ts of clinical trial procedures, development of a new protocol, amending protocols, scientific and ethical review of clinical protocols will be discussed. The clinical trial protocol is a multi-dimensional document that plays a critical role in the success of a clinical trial. There are many schools of thought about the best approach to writing a clinical trial protocol depending on individuals or organizations sponsoring a given clinical trial. Areas Covered in the Session: • The overall structure of a protocol and regulatory requirements • Identify who contributes to the protocol development and amendments • The element of a protocol such a background scientific rationale, design • (single blind, double blind, randomized, etc.), primary and secondaryendpoints, • inclusion/exclusion criteria, the Schedule of Events, adverse • event management, • statistical parameters, informed consent, and study synopsis • Practical issues with protocol writing such a differences in various phases of clinical trials, • the protocol review process, using key opinion leaders, and using public resources and templates • Common issues with FDA and IRB approval of clinical protocols.

2. Who Will Benefit: • Regulatory Affairs Professionals • Sponsors of INDs • Senior Management Executives (CEO, COO, CFO, etc) • Drug Discovery and Development Professionals (R&D and CMC) • Clinical Trial Managers • Project Managers and Clinical Trial Specialists • Regulatory Compliance Associates and Managers • People Investing in FDA-Regulated Product Development Projects SpeakerProfile: Dr. Mukesh Kumar is a Washington DC-based consultant in regulatory affairs and quality assurance for manufacturers and developers of FDA-regulated products. He and leads the Regulatory Affairs and Quality Assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD. His key expertise is in regulatory affairs, clinical trials and multinational project management for medicinal and diagnostic products. He has been involved in about 100 clinical trials in more than 40 countries, has made several hundred US FDA submissions, and arranged a number of meetings with the US FDA. In addition, he has had made regulatory submission in the EU and India. He has conducted GCP, GLP, GMP and GACP audits in the US and several countries in Europe and Asia. He has conducted numerous training workshops in FDA compliance related issues. He has authored numerous articles in peer-reviewed journals. He is a well known expert in global regulatory affairs and has been an invited speaker at several professional and academic organizations worldwide. Dr. Kumar is a PhD in Biochemistry and has worked as a research scientist at the NIH, Baylor College of Medicine, Houston, and premier institutions in India. He is a certified regulatory affairs professional by the Regulatory Affairs Professional Society, USA. www.compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=FDB1108