Request for Registration for the 2016 Health Products and Food Branch (HPFB) International Regulatory Forum

Request for Registration

October 19-21, 2016
Ottawa, Canada

Section 1: General Information

Participation in the Forum is only open to International Regulatory Agencies. There is no registration fee, however participants are responsible for their own travel and accommodation costs.

Requests for Registration must be submitted by Thursday, June 30, 2016 and should be sent by email or fax (information below).

HPFB Forum Registrar

Email: HPFB_Forum_DGPSA@hc-sc.gc.ca

Once we receive your completed 'Request for Registration' form, an official Invitation Letter will be sent to you within 2 weeks. If you have not received a letter within 2 weeks of submitting your Request for Registration, please contact us at the above email to ensure we have received your information. Details on venue and special guest room rates will follow.

Section 2: Contact Details (Please Print)

• (Mr / Mrs / Ms / Dr)
• Surname
• Given Name
• Full Name as shown on your passport
• Name of Regulatory Agency
• Country
• Title / Position in Regulatory Agency
• Work Telephone (with country/area codes)
• Work Fax (with country/area codes)
• Email Address(es)

Section 3: Special Requirements

Please indicate if you have special requirements during the Forum (e.g. wheelchair accessibility):

Section 4: Language Preference

Simultaneous interpretation will be offered in English and French for all sessions. Spanish interpretation will only be offered for specific product lines (to be confirmed but tentatively anticipated to include Vaccines). All materials will be available in English and French.

Please indicate your language preference(s) in the following table.

Languages in which you have sufficient working ability to participate in the Forum.
(Please select all that apply)

• English
• French
• Spanish

Preferred Language
(Please select only one)

• English
• French
• Spanish

Section 5: Forum Materials

Only electronic versions of Forum materials will be provided. All participants will receive a USB memory stick. We request that all participants bring their own laptops (and international adaptor). Please contact us if you have any questions or concerns.

Section 6: Program Preferences

6. A. Product Line

The 2016 Forum will provide a detailed overview of the Canadian regulatory process for biologics, vaccines and pharmaceuticals throughout the pre- and post-market product lifecycle. To allow for a comprehensive examination of regulatory issues, some sessions will be offered in parallel.

Please indicate the product line of greatest interest to you. This does not restrict your attendance at the other sessions.

Product Line of Primary Interest (Select ONE)

• Biologics (with a focus on Vaccines)
• Pharmaceuticals

6. B. Pre-market

Please indicate the topics of greatest interest to you.

Pre-Market Topics of Interest (Select ALL that apply)

• Overview of processing, screening and reviewing a submission
• Pre-market review of vaccines
• Special Topic (TBD) on vaccines
• Pre-market review of pharmaceuticals (including generic drugs)
• Regulation of clinical trials
• Other:

6. C. Post-Market Surveillance, Compliance and Enforcement

Please indicate the topics of greatest interest to you. Select ALL that apply.

Post-Market Surveillance

• Adverse Reaction Monitoring and Assessment
• Signal Detection

Establishment Licensing

• Drugs
• Certificates of Pharmaceutical Product (CPP)
• Medical Devices Manufacturer Certificates

Compliance verification, Border, Laboratory

• Drugs
• Border Programme
• Regulation of import/export of health products
• Inspectorate Laboratory Programme
• Analysis of counterfeit and adulterated products

Inspections

• GMP: Risk Management, Quality Systems, and Inspection Processes
• Radiopharmaceuticals (GMP)
• Good Clinical Practices Compliance Program
• Inspection Scheduling and Frequency
• Risk Ratings

6. D. Other Interests

Please also let us know if there are any other regulatory topics of specific interest to you. While we will not be able to include all possible regulatory topics in the Program, we will do our best to accommodate your suggestions.