Participants will gain in-depth knowledge of Health Canada's guidance documents for preparing new Drug Submissions (NDS), which is critical for those involved in the preparation of chemical drugs, biologicals, biopharmaceuticals, biosimilars, and chemical generics. The workshop will cover essential areas such as Chemistry Manufacturing and Controls (CMC), Nonclinical, and Clinical aspects within the ICH CTD module format. Attendees will also have the chance to engage in practical exercises by working on a mock submission binder, providing hands-on experience that is directly applicable to their professional roles. This workshop is particularly suited for individuals in regulatory affairs, quality assurance, product development, and other related fields within the pharmaceutical and allied industries. It is an essential learning opportunity for those looking to enhance their skills in NDS submission, CTD module navigation, eCTD implementation, and practical submission preparation. |
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