2-day In-person Seminar on Submitting Marketing Applications in Canada at Seattle, Washington

Overview:

Topics included will include the filing of New Drug Submissions for various types of pharmaceutical companies, priority submissions, organization of Health Canada, process for approval of applications, timeframes and cost for approval. We will cover the review of New Drugs and Old Drugs. Also included will be Natural Health Products. Canada has pricing controls, unlike the US. Reimbursement in Canada is very much related to the healthcare system in Canada. An overview of reimbursement will be covered.

Why should you attend?

Understanding the process in Canada for the registration of new chemical entities, generic products, 505(b)(2) equivalent submissions, biosimilars will open this market to your company. This seminar will provide you with clear guidance in terms of how to manage your registration activities in Canada. Included will be a discussion of postmarketing changes, advertising, pharmacovigilance, pricing control and reimbursement.

Who Will Benefit:

·         Regulatory Affairs Personnel (Coordinator, Manager, Director, VP)

·         General Managers

·         Marketing (manager, Director, VP)

·         Business Development personnel

Agenda

Day One:

Lecture 1: Drug Regulation in Canada and Overview of Health Canada

Lecture 2: The Common Technical Document

Lecture 3: New Drug Submissions (Standard, Priority, NOC/C, Exclusivity)

Lecture 4: New Drug Submissions (Biologics, Generics, Subsequent Entry Biologics)

Lecture 5: New Drug Submissions (Fees, Time for Reviews, Appeals)

Day Two:

Lecture 1: DIN Submissions

Lecture 2: Changes Post NOC

Lecture 3: Natural Health Products

Lecture 4: Advertising

Lecture 5: Pharmacovigilance (Regulations, Guidelines, Inspections)

Lecture 6: Pricing Regulations

Lecture 7: Reimbursement

Instructor Profile:

Anne Tomalin

President, Therapeutic Products Inc. 

Anne Tomalin Therapeutic Products Inc. in September 2013. TPIreg is a Regulatory Affairs boutique firm specializing in Canadian Regulatory Affairs. Anne also founded CanReg Inc. in September 1996. CanReg was acquired by OptumInsight in December 2009. Prior to founding CanReg, Anne was employed for 20 years with Searle Canada, A Unit of Monsanto Canada Inc. as Business Unit Director. Responsibilities in the last several years at Searle included regulatory affairs, provincial government, reimbursement strategies, managed care, customer interface, and legal and information services. Prior to joining Searle, Anne was employed by Hoffmann-LaRoche Limited for three years. Prior to Roche, Anne was employed for three years by Wyeth Ltd.

Location: Seattle, WA        Date: June 18th & 19th, 2015        Time: 9 AM to 6 PM 
Venue: Courtyard Seattle Sea-Tac Area

Venue Address: 16038 West Valley Highway Tukwila Washington 98188 USA

Price: $1,295.00

(Seminar for One Delegate)

Register now and save $200. (Early Bird)

Until May 10, Early Bird Price: $1,295.00

From May 11 to June 16, Regular Price: $1,495.00

Registration Details:

NetZealous LLC,

DBA GlobalCompliancePanel

161 Mission Falls Lane,

Suite 216, Fremont, CA 94539, USA         

USA Phone: 1-800-447-9407

Fax: 302-288-6884

support@globalcompliancepanel.com          

http://www.globalcompliancepanel.com

Event Link - http://bit.ly/Seminar-on-Submitting-Marketing-Applications-in-Canada-Seattle-Washington