As drug companies seek to penetrate global markets and get new drugs to markets more quickly, they are increasingly conducting drug and biologic clinical studies outside the United States. The regulatory affairs professional must keep abreast of the ever-changing regulatory climate, and be able to complete IND-like submissions in a variety of formats, and with country/regulatory agency-specific requirements in mind.
This course will walk the participants through the country requirements, IND submission requirements, and timelines for approval in Canada, the EU, South Africa, Australia, Asia, and South America using the U.S. IND as the basis for comparison. After the initial IND filings are reviewed, what work will be needed for maintaining the submission and closing the trial will be examined.
At the end of this course, the participant will be familiar with how to:
- Find information about country specific regulations
- Navigate regional regulatory requirements for IND like submissions
- File an IND-like submission
- Identify translations needed
- Establish timelines for approval of submissions
- Maintain an IND-like submission
- Anticipate what is needed when the trial ends
The focus of the course will be on in-depth coverage of the Canadian and EU Clinical Trial Application (CTA), going over the forms, required contents, re-use of information, and country specific requirements/information. In addition, for Canada, the EU, and the other countries, the following information will be covered:
- Overview of the country
- Pertinent laws and regulations
- MOH address and contact
- Clinical trial documents needed
- Clinical Trial Applications
- Responding to agency questions
- Regulatory approval, process, and timelines
- Submission logistics
- GCP and GMP requirements
- Ethics committee requirements
- Informed consent
- Insurance requirements
- Labeling of clinical supply
- Importing requirements
- Serious adverse event reporting
- Annual reporting
Mock EU and Canadian CTAs will be provided as a reference.
- Any part of the drug development team who wishes to know more about the global IND submission process such as: regulatory associates, regulatory managers, quality assurance, manufacturing, clinical, project management, and pre-clinical personnel will benefit from this course.
The course will be led by one of the following instructors:
Meredith Brown-Tuttle, R.A.C.
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Day 1: 8:30 a.m. – 5:00 p.m.
- The following countries will be reviewed, in detail, for their IND-like submissions and maintenance: Canada; EU (all EU countries, including Iceland, Switzerland, and Norway but not Liechtenstein, Luxemburg, Monaco, or San Marino); Eastern EU (Bulgaria, Czech Republic, Estonia, Hungary, Latvia, Lithuania, Poland, Romania, Russia, Slovak Republic, Slovenia, Turkey, and Ukraine; but not Belarus, Moldova, or Yugoslavia); EU Accession Countries (Albania, Bosnia-Herzegovina, Croatia, Kosovo, Macedonia, Montenegro, and Serbia)
Day 2: 8:30 a.m. – 5:00 p.m.
- Review the IND-like contents, submissions requirements, maintenance, and end-of-trial documents for: West and South Africa; India; China; Japan; Australia; Middle East (Egypt, Israel, Saudi Arabia, United Arab Emirates); Asian countries overview of clinical trial documentation requirements; Latin/South American countries overview of clinical trial documentation requirements
- As a team, preparing a list of all the documents needed to start a trial and comare them across different countries
- Understanding the requirements for Canadian and EU forms and applications
Registration fees include assorted breakfast items that will be available each day ½ hour prior to the start of the seminar. Also included is a Networking Lunch that will be served each training day.
Special rates are available for multiple attendees from the same organization. Contact Elizabeth Andrews at 781-972-5418 to discuss your options and take advantage of the savings.
Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 15 hours (1.5 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test and program evaluation. Barnett International will mail ACPE statements within three weeks of program completion. ACPE# 0778-0000-12-094-L01-P. Released: 9/12.
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471.