This introductory workshop provides a foundational understanding of Regulatory Affairs in the healthcare industry, focusing on the drug development process and new drug submissions. Participants will gain insights into the steps involved in getting a new drug approved, including the different notice types, priority review policies, and the importance of pre-submission meetings. The workshop also covers the submission formatting and screening process, with an emphasis on the Common Technical Document (CTD) and the advantages of electronic CTD (eCTD) submissions. By the end of this workshop, participants will have a clear understanding of the regulatory landscape and the essential components of drug submissions.
This workshop is ideal for individuals new to Regulatory Affairs or those looking to strengthen their foundational knowledge. It is particularly beneficial for professionals working in the pharmaceutical industry, including regulatory affairs specialists, drug development professionals, quality assurance personnel, and anyone involved in the submission and approval process of new drugs.
This workshop covers the following topics:
Gain knowledge of the essential components and structure of regulatory submissions, including the Common Technical Document (CTD) and electronic Common Technical Document (eCTD).
Comprehend the Drug Development Process:Learn the critical steps involved in drug development, from concept to approval.
Navigate the New Drug Submission (NDS) Process:Acquire knowledge on the components and requirements of a new drug submission.
Utilize the Common Technical Document (CTD):Understand the structure and advantages of the CTD and eCTD in regulatory submissions.
All participants will receive a certificate of attendance upon completion of the workshop.Note: Registration closes one week prior to the start of workshop.
