Clinical Trial Applications in Canada

About GlobalCompliancePanel:GlobalCompliancePanel is a training source that delivers diverse, high quality regulatory & compliance trainings. These trainings are simple while being relevant and cost-effective while being convenient. GlobalCompliancePanel imparts knowledge of best practices across a broad range of user-friendly mediums such as webinars, seminars, conferences and tailored, individualized consulting. These help organizations and professionals implement compliance programs that meet regulatory demands and put business processes in place. Through our trainings, we bring together the regulators or experts on regulation on the one hand, with the community that needs to learn or be aware of those regulations, on the other.Our services benefit the Medical Devices, Pharmaceutical, Bio Technology, Food Safety, Financial Accounting Standards, and IT Control & PCI Industries. Our clientele includes companies such as J&J, Pfizer, Sanofi Aventis, Pall Corp, Abbott, Merck, Bayer, and Roche, some of which are Fortune 500 companies. P ro fess iona l s who unde rgo t ra in ings f rom GlobalCompliancePanel exhibit a vastly improved quality of life in which there is increased productivity and professional growth. Some 30,000 professionals have gained from more than 500 training courses we have conducted till nowNet Zealouswww.globalcompliancepanel.com All rights are reserved © GlobalCompliancePanel.2-day In-person Seminar:Clinical Trial Applications in Canada, and Comparison to US and EUBy: President, Therapeutic Products Inc.Anne Tomalin,Location: | March 27-28, 2014Toronto, CanadaGlobalCompliancePanelCourse "Clinical Trial Applications in Canada, and Comparison to US and EU" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recerti?cation upon full completion. www.globalcompliancepanel.com All rights are reserved © GlobalCompliancePanel.Anne Tomalin, President, Therapeutic Products Inc.2-day In-person Seminar 2014Anne Tomalin has practiced exclusively in the area of regulatory affairs since 1971. She has a strong background in business, government, regulations and reimbursement policies.Anne is a graduate of York University, and holds a B.A. degree in English (1970) and a B.Sc. degree in Chemistry (1980). Anne has received a Regulatory Affairs Certification from the Regulatory Affairs Professional Society for US Regulatory Affairs (1997), European Regulatory Affairs (2001) and Canadian Regulatory Affairs (2005).Anne founded Therapeutic Products Inc. in September 2013. TPIreg is a Regulatory Affairs boutique firm specializing in Canadian Regulatory Affairs.Day One - March 27, 2014 Day Two - March 28, 2014Course Outline:GlobalCompliancePanelLecture Agenda Content TimingRegistration 8:30 - 9:00Lecture 1:Regulatory Basis for Oversight of Clinical Trials9:00 - 9:30Lecture 2: Overview of Health Canada 9:30 - 10:00Lecture 3: Filing a CTA in Canada 10:00 - 10:30Coffee Break 10:30 - 11:00Lecture 4: Filing a CTA in Canada 11:00 - 12:00Lecture 5: Amendments to Protocols and Supplies 12:00 - 12:45Lunch Break 12:45 - 1:45Lecture 6: Good Clinical Practice 1:45 – 3:15Coffee Break 3:15 - 3:45Lecture 7: Inspections and Q & A 3:45 - 5:30Lecture Agenda Content TimingLecture 1: Review of Day 1 8:30 - 9:30Lecture 2: Special Considerations for Biologics 9:30 - 10:30Coffee break 10:30 - 11:00Lecture 3:Special Considerations for Gene Therapy11:00 - 11:45Lecture 4:Special Considerations for Use of Devices in Clinical Trials11:45 - 12:45Lunch break 12:45 - 1:45Lecture 5: Pharmacovigilance in Clinical Trials 1:45 - 2:45Lecture 6: Phase IV Clinical Trials 2:45 – 3:15Coffee Break 3:15 - 3:45Lecture 7: Research Ethics Boards 3:45 - 4:15Lecture 8: Clinical Trial Groups 4:15 - 4:45Lecture 9: Q & A and Wrap Up 4:45 - 5:30Course Outline: Why you should attend:This seminar will cover the organization of Health Canada as it relates to clinical trials and drug development, Canadian regulations governing the conduct of clinical trials in this country, the process for getting approval of clinical trials, requirements after approval of the trial, submission of safety data, inspections by Health Canada related to clinical trials, Good Manufacturing Procedures (GMP) requirements for clinical trials, the conduct of Phase IV clinical trials, and pending changes to the conduct of clinical trials in Canada. We will review requirements for drugs, biologics, gene therapy and natural health products. In addition, we will discuss the conduct of clinical trials in Canada to the conduct of such trials in the US or EU. Conducting clinical trials is a global undertaking. Understanding the details of conducting such trials in Canada will enable companies to add Canadian sites to their global trials, and access the excellent network of researchers in this country. The FDA recognizes Canadian sites as US sites in their review of NDAs. Within Canada there are signi?cant tax credits related to the conduct of clinical trials in this country. Canadian researchers and drug developers can best make use of these ?scal policies by understanding clearly how to conduct research in Canada. For Canadian companies it is important to understand how research is done in this country and how it compares to the US and EU. Raising money to fund research will require that you present clearly the strategy for development that you are following in Canada, the US and EU.www.globalcompliancepanel.com All rights are reserved © GlobalCompliancePanel.2-day In-person Seminar 2014Register now and save . (Early Bird)$200Until March 10, Early Bird Price: $1,395.00From March 11 to March 25, Regular Price: $1,595.00March 27-28, 2014 | Toronto, Canada**Please note the registration will be closed 2 days (48 Hours) prior to the date of the seminar.Price for One Delegate pass Price: $1,395.00Pricing list:1. Learning Objectives2. Participation certificates3. Interactive sessions with the US expert4. Post event email assistance to your queries.5. Special price on future purchase of web based trainings.6. Special price on future consulting or expertise services.7. Special price on future seminars by GlobalCompliancePanel. 8. Seminar Kit – includes presentation handout, ID card, brochure, trainings catalog, notepad and pen.9. Networking with industry's top notch professionalsWhat you get? Credit Card: Use the Link to make Payment by Visa/Master/American Express card click on the register now link? Check: Kindly make the check payable to NetZealous DBA GlobalCompliancePanel and mailed to 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA? PO: Please drop an email to support@globalcompliancepanel.com or call the our toll free 1800 447 9407 for the invoice and you may fax the PO to 302 288 6884 ? Wire Transfer: Please drop an email to support@globalcompliancepanel.com or call our toll free 1800 447 9407 for the wire transfer informationPayment Options:? Director of Regulatory Affairs? Regulatory Affairs Managers? Coordinator of Regulatory Affairs? Regulatory Affairs Associate? Clinical Research AssociateWho Will Benefit:? Clinical Manager? Director of Product Development? Pharmacovigilance Manager for Clinical Trials? R&D Managers and DirectorsContact Information: Event CoordinatorToll free: 1800 447 9407 Fax: 302 288 6884Email: support@globalcompliancepanel.comNetZealous LLC, DBA GlobalCompliancePanel161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USAKindly get in touch with us for any help or information.Look forward to meeting you at the seminarTeam GlobalCompliancePanelGlobalCompliancePanelwww.globalcompliancepanel.com All rights are reserved © GlobalCompliancePanel.Registration :FormPlease use this form to register online, using your American Express, Visa or MasterCard.To get discounts on group attendance, please call us on +1-800-447-9407Call us on or fax your PO to 302 288 6884+1-800-447-9407Please pay your check issued from the payee to NetZealous LLC, our parent company, and mail it to NetZealous, 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA Please call us at or email us at Please ?ll this form out and include +1-800-447-9407 support@globalcompliancepanel.comattendee and payment details in it and fax it to 302 288 6884Terms and ConditionsYour registration for this seminar is bound by terms and conditions spelt out here. Please call or mail us if you have any clari?cations or doubts on this issue.Cancellations and SubstitutionsIf you wish to cancel your attendance at our seminar, the person who has registered for this seminar has to submit written cancellations through fax or email at least 10 calendar days before the date of commencement of the event. This will entitle her/him to a full refund minus a $150 administration fee. No cancellation request will be accepted or entertained and no refunds will be issued for requests made outside the stipulated period.A request to this effect has to be sent by email or fax more than ten days before the commencement date of the seminar. After receiving this request, we will issue a credit for the amount paid with a deduction of administration fees of $150. This credit note will be transferred to a future GlobalCompliancePanel event, and a credit note will be issued towards this.You are allowed to make substitutions at any time till the start of the event. The substituting person should be present well in time for the event with proper written communication and company identity.If registering on the date of the seminar, please make sure you pay for the event using your credit card or check just before the start of the event. To such attendees, we may not be able to give the conference materials on the spot. In such an event; we will send the same after the conclusion of the seminar.No-shows will not be reimbursed.If GlobalCompliancePanel cancels an event, we will not be reimbursing any airfare, accommodation, other costs or losses that the registrants may have incurred. GlobalCompliancePanel reserves the right to change topics and speakers without notice.Seminar Topic:......................................................................................................................................................Date:.....................................................................................................................................................................Attendee 1 : Name ............................................... Title ..................................................... Email ..................................................Attendee 2 : Name ............................................... Title ..................................................... Email ..................................................Attendee 3 : Name ............................................... Title ..................................................... Email .................................................. 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Fax .............................................Payment Options Check enclosed, payable in U.S. funds to NetZealous LLC, DBA GlobalCompliancePanel Charge to: Visa MasterCard American ExpressCredit card no. ............................................................................Expiration date ............................................................................CVV Number ..............................................................................Total amount $ ............................................................................Signature ....................................................................................(Signature required on credit card and bill-me orders.)Print name .................................................................................. Bill me/my company $ ............................................................Purchase order # ........................................................................(Payment is required by the date of the conference.)Please ?ll this form with attendee details and payment details and fax it to 302 288 6884NetZealous LLC, DBA GlobalCompliancePanel161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USAToll free (US): +1-800-447-9407 / Fax (US): 302 288 68842-day In-person Seminar 2014GlobalCompliancePanel