Drug Development Process – From Discovery to Marketing

Drug Development Process - From Discovery to Marketing

Overview:

This webinar will provide a clinical and regulatory perspectives on requirements to take a new drug from research to market.

We will begin by reviewing the contents of an Investigational New Drug (IND) application, and then follow the process of an IND submission. Next, the contents and approval process of an NDA submission will be discussed. This seminar will also provide a foundation for those who require an understanding of the FDA new drug approval process, and familiarize the attendees with the regulatory landscape in which INDs and NDAs are developed and approved.

Areas Covered in the Session:

  • High level overview of the FDA approval process for a new drug
  • What is an IND? Identify the key contents of an IND
  • What is an NDA? Identify the contents of an NDA
  • The FDA IND and NDA review process
  • Discovery stage
  • Preclinical Testing
  • IND Application
  • Clinical Trials
  • Phases I to IV
  • NDA
  • High-level description of medical device process

Who Will Benefit:

  • CRAs
  • CRCs
  • Nurses
  • Clinical Trials Associates
  • Regulatory Affairs

Speaker Profile

Fatuga is a social-entrepreneur who is actively engaged in three primary roles/companies: (a) founder/president of Caligeo Clinical OneVision; (b) founder/CEO of Caligeo Clinical CRO; and (c) founder/Executive Director of Atlanta Premier SMO. His professional passion lies in promoting clinical trial opportunities in emerging markets (especially in Africa, the Caribbean, East Asia, and Latin America) and among under-represented population (in the USA). He recently completed his MBA degree from Emory University/Goizueta Business School with a focus on Entrepreneurial ship/Organizational Behavior & Management. He received his M.Sc. in Drug Regulatory Affairs and Health Policies from Massachusetts College of Pharmacy and Health Sciences and BS degree in Neuroscience from Brown University. He has more than 15 years of experience in the clinical research industry. Fatuga began his clinical research career as a study coordinator at Brown University. Since then, he has had leadership opportunities as Clinical Team Manager, Project Lead, QA/QC Manager, Lead CRA, CRA Consultant, Medical Research Associate, and CRA Specialist in a variety of companies such as central imaging facility, Contract Research Organizations (CROs), biotechnology and pharmaceutical companies. Fatuga is currently certified as a Project Management Professional (PMP) and a Clinical Research Associate (CCRA). He is an active member of the International GCP Training Advisory Board for the Association of Good Clinical Practices in Nigeria (AGCPN) and also a member of Nigerian Association of Pharmacist and Pharmaceutical Scientists in the Americas (NAPPSA). Fatuga is also a member of the International Committee/Leadership Team of the National Biotechnology and Pharmaceutical Association (NBPA) which is a US based organization functioning in collaborative efforts to discuss challenges and opportunities of conducting clinical trials with diverse communities as well as addressing the disparity issues in the clinical trial industry.

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Master regulatory files

Master regulatory files are a set of documents the manufacturer of a drug or medical device has to furnish to the FDA. A Drug Master File (DMF) is a prime example of a kind of master regulatory files. Master regulatory files are provided to the regulatory authority to provide confidential information about the product, such as its design, the process, and the sample of the clinical trials and so on.

A firewall

Master regulatory files are what may be termed the blueprint for the product, because they contain all the vital information about the product. Information contained in master regulatory files is critical and acts as a ready reference for the regulatory authority. It protects the manufacturer from the risk of manipulation from other players in the field should such a situation arise. Master regulatory files may not have the same power or effect of copyrights or patents, but they contain important information about the product, nevertheless. They insulate the manufacturer from duplication and replication from competitors who may access the information about the drug or medical device.

Important points to remember about master regulatory files

Given the importance of master regulatory files; it is necessary to understand what is needed for its upkeep:

  • Documentation is at the heart of master regulatory files. Every step, small or big, has to be documented
  • Informed consent from the subjects who underwent the clinical trial
  • Record or copy of the approval obtained from the Institutional Review Board (IRB), which is the green signal for commissioning the clinical trial
  • Details of adverse events before, during and after the clinical trial
  • Details of storage of data
  • Clear instruction on whom in the organization maintains and updates master regulatory files and organizing them properly

References:

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySystemsRegulations/MedicalDeviceQualitySystemsManual/ucm122576.htm

http://www.knowledgenet.in/drug_master_file.html

http://hspo.uchc.edu/education_resources/newsletters/pdfs/2006/newsletter_novdec06.pdf

Contact Detail
GlobalCompliancePanel
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