Regulatory Perspectives of Clinical Project Management: Meeting FDA Requirements for Clinical Trials

Why Should You Attend:

Clinical project managers need to have clear perspective of what may be needed for assuring compliance with FDA requirements of a given clinical trial at all times. Non-compliance with these requirements could lead to rejection of the trial data, and even other more severe penalties.

This course will provide an overview of regulatory management for clinical trials. It will discuss the key regulatory aspects of a clinical project such as clinical protocol management, IRB management, safety reporting, rules for recruitment programs, seeking advice from FDA, trial master files, and training requirements. Practical tips for regulatory management of a clinical trial project will be provided using case studies from the presenter’s personal experience. If you are aspiring to be a clinical project manager, sponsoring a clinical trial, supervising clinical trial operations, or would like to become a clinical site investigator, this course is a must for you.

Learning Objectives:

At the end of this webinar, attendees will be familiar with:

• Most common regulatory issues in clinical trial management.
• Documents required for FDA submission and trial master files.
• Processes to seek and document management decisions with regulatory implications.
• Do's and don'ts for regulatory management of a clinical trial.

Areas Covered in the Webinar:

• Overview of FDA requirements for clinical trials under an IND or IDE application.
• Regulatory responsibilities of the clinical project manager.
• An ideal clinical trial protocol and processes to amend it.
• Addressing adverse events and safety reporting.
• Management of randomization, blinding, unblinding, and DSMB review.
• Managing investigational products: stability, storage, accountability, and expiry.
• IRB review and review of the IRB processes by sponsors.
• Recruitment strategies.
• Documents to submit to FDA and those that are not needed.
• When and how to seek regulatory clarification.
• Risk management: key techniques in risk reduction, assessment, addressing, training and communication.
• Corrective and Preventive Actions (CAPA) for clinical trial projects.
• Do's and don'ts of investigator meetings.
• Challenges of large-scale and international clinical trials.

Who Will Benefit:

• Clinical project managers
• Clinical research associates
• Clinical coordinators
• Principal investigators and sub investigators
• IRB personnel
• Regulatory vice presidents, directors and managers
• Attorneys – in-house or outside counsel

Instructor Profile:

Dr. Mukesh Kumar is a Washington DC-based consultant in regulatory affairs and quality assurance for manufacturers and developers of FDA-regulated products. He 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 multi-national project management for medicinal and diagnostic products. He has been involved in over 100 clinical trials in more than 40 countries, has made hundreds of US FDA submissions, and arranged a number of meetings with the US FDA. In addition, he has made regulatory submissions in the EU, Taiwan, Korea, China, Canada, countries in South America, Australia, and India. He has conducted GCP, GLP, GMP and GACP audits in the US and several countries in Europe, North and South Americas and Asia.

Dr. Kumar 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 in several professional and academic organizations worldwide. Dr. Kumar has a PhD in Biochemistry and is a regulatory affairs professional certified by the Regulatory Affairs Professional Society, USA.

Follow us :