BioEntrepreneurship - Navigating the Global Regulatory Path for New Drugs
COURSE DESCRIPTION
So you have a device or drug candidate and you are ready to take it into humans. Now what? This course will cover the how-to's of the regulatory approvals process. It will include a review of the submissions required to be filed for conducting clinical trials in the US, Europe or Canada and insight into strategies that have been successful in the past and potential pitfalls to be avoided. The course will also cover marketing applications for these three regions, including a discussion of how the International Conference on Harmonization fits into the overall regulatory scheme of drug development.SPEAKER
- Anne Tomalin, CanReg Inc.
TOPICS ADDRESSED
- Planning ahead to add credibility and value with your partners, investors and outside experts
- What is the landscape of various filings for a drug, a medical device or a diagnostic device?
- Developing a multi-disciplinary project team to manage your regulatory strategy:
- Different strategies for different products
- How to formulate a sound path to drug development decision-making
- What is needed for approval of a medical device
- The preclinical studies required for an IND filing
- The multiple components of the actual IND submission
- Management and communication between the teams assembling the IND
- When to outsource and bring in consultants
- Interacting with the regulatory authority
DATE | TIME | LOCATION
January 15, 2007 - January 15, 20076:00PM - 9:00PM
MaRS Collaboration Centre
101 College St, Toronto
ABOUT THE SPEAKER
Anne Tomalin, BA, BSc, RAC (US, CAN & EU), President of CanReg Inc., founded the company in 1996. She has practiced regulatory affairs exclusively since 1971. Over that time, she has worked with three international pharmaceutical companies to obtain registrations for prescription pharmaceuticals, OTCs and medical devices. Anne worked for 20 years at Searle Canada, being a Business Unit Director when she left to start CanReg. Before joining Searle, she was employed by Hoffmann-La Roche for three years, and Wyeth prior to that. Anne is a graduate of York University with a BSc(Chemistry) and a BA(English).DOWNLOADS AND RESOURCES
Audio Presentation:Slideshow:
ABOUT THE BIOENTREPRENEURSHIP SERIES
Click here for more information about the BioEntrepreneurship Series.
UPCOMING EVENTS
PAST EVENTS
- March 12, 2008
BioEntrepreneurship: What Investors Look For in Life Science Businesses - February 27, 2008
BioEntrepreneurship: Budgeting for life science companies - February 6, 2008
BioEntrepreneurship: Life Science IP - January 16, 2008
BioEntrepreneurship: Navigating the Global Regulatory Path for New Drugs - January 9, 2008
BioEntrepreneurship: Market Assessement for Therapeutics and Medical Devices - December 19, 2007
BioEntrepreneurship: Business Models in Therapeutics and Medical Devices - June 12, 2007
BioEntrepreneurship - Effective Communications: Selling your story to VCs and beyond - May 14, 2007
BioEntrepreneurship - Strategic Financing of Biotech - April 16, 2007
BioEntrepreneurship - VCs and CVs: Managing the people/profit equation - February 12, 2007
BioEntrepreneurship - Clinical Trials Strategy - January 15, 2007
BioEntrepreneurship - Navigating the Global Regulatory Path for New Drugs - December 4, 2006
BioEntrepreneurship - Intellectual Property Strategy - November 13, 2006
BioEntrepreneurship - Market Assessment: Great New Product or Just Really Cool Science? - October 16, 2006
The Business of Biotech
MaRS PICKS
Who's Your City?Because it always helps to do your taxes right! Certified General Accountants of Ontario help Ontar...The World is Flat
MaRS BLOG
- Fail to design = design to fail
- Experience is our obsession: Innovation and the design ecosystem
- Tech in the Soo