eCTD Submissions of IND/NDA to the US FDA, EU and Canada

  • Check with publisher
  • Published date: October 14, 2020
    • Fremont, California, United States

The international agreement to assemble all Quality, Safety and Efficacy information for a drug or biologic product into a common format (called the CTD - Common Technical Document) has improved the speed and efficiency for companies working in global development programs and clarified expectations by regulatory bodies.

Reformatting for multiple submissions is substantially limited. The CTD has improved the regulatory review processes and enabled implementation of good review practices. The eCTD has increased efficiency for reviewers and improved submission times. Beginning in May 2017, the eCTD will be required in the US for all marketing applications.

https://www.gcplearning.com/virtual-seminar/6-hour-virtual-seminar-on-ectd-submissions-of-ind-nda-to-the-us-fda,-eu-and-canada-11553LIVE

Result 0 votes
John Robinson
0 votes

Useful information

  • Avoid scams by acting locally or paying with PayPal
  • Never pay with Western Union, Moneygram or other anonymous payment services
  • Don't buy or sell outside of your country. Don't accept cashier cheques from outside your country
  • This site is never involved in any transaction, and does not handle payments, shipping, guarantee transactions, provide escrow services, or offer "buyer protection" or "seller certification"

Related listings

  • 6-Hour Virtual Seminar on Applying ISO14971 and IEC62304

    6-Hour Virtual Seminar on Applying ISO14971 and IEC62304

    Medical Sciences Fremont (California) October 14, 2020 Check with publisher

    Gaps, incorrect or incomplete implementation of safety functionality can delay or make the certification/approval of medical products impossible. Most activities cannot be retroactively performed since they are closely linked into the development lif...

  • Drafting and Negotiating Physician Employment Contracts

    Drafting and Negotiating Physician Employment Contracts

    Medical Sciences Fremont (California) October 14, 2020 Check with publisher

    Overview: In this session Mr. Wolfe will provide practical guidance regarding physician employment contracts,including key regulatory requirements, key provisions and common compensation and common compensation models. Why you should Attend: Today th...

  • Telemedicine: Reimbursement Update

    Telemedicine: Reimbursement Update

    Medical Sciences Fremont (California) October 14, 2020 Check with publisher

    Overview: Under the Social Security Act, reimbursement for telehealth under Medicare has been subject to stringent restrictions. Only patients in certain identified practice settings in rural, physician-underserved areas were eligible. Care into the ...