Director's Office of the Bureau of Microbial Hazards, Food Directorate

Bureau of Microbial Hazards, Food Directorate Pre-Market Assessment • Microbiological Assessment of Novel Food (Division 28) and Food Additive (Division 16) submissions. • Policy Development.• Novelty determination assessments: Authored and presented Novelty Issue Sheets. Lead scientific and regulatory discussions.• Novelty determination assessments of TMALs: provided novelty assessments of ingredients for foods applying for a Temporary Marketing Authorization (as per B.01.054 and B.01.055 of the FDR).• Policy development: Drafting of guidance documents related to the Novelty determination.

Pre-Market Assessment • Nutritional Assessment of Novel Food (Division 28) and Food Additive (Division 16) submissions. Lead evaluator in selected file assignments: Coordinating multi-disciplinary reviews, compiling the assessments into a Food Rulings proposal, and presenting the results to the Director General and FD management team for consideration.• Risk Assessments of Food-like NHP products, 2012 Transition team was required to handle the transition over 1300 products within less than 1 year. - High productivity: personally completed over 200 out of 383 necessary product assessments (85 were handled via policy change).Policy Development• Policy development: Initial drafting of the guidance document for industry stakeholders for Non-Caffeinated Energy Drink products.• Policy consultation: (In progress) drafting of the summary of comments from the consultation of the Pre-Market Submission Management Process for Food Additives, Infant Formulas and Novel Foods.• Coordination and Secretariat responsibilities (ex. Food-NHP Classification Committee, Member of the Food Executive team for Energy Drinks).Submission Tracking / Performance Tracking• Submission tracking and performance reporting.• Knowledge transfer.Foods for Special Dietary Use (Division 24) evaluation.• Pre-market and Post-market review of Foods for Special Dietary Use, regulated under Division 24 of the Food and Drug Regulations.Infant Formula Pre-market Review (Division 25 of the FDR)• Submission screening of received pre-market submissions. • Infant Formula quality specifications review (maximum and minimum batch release specifications).• Point of contact for a Human-Milk Fortifier assessment that was linked to an urgent health issue (2010).Business Continuity Plan update• Assisted the Business Continuity Plan Coordinator with yearly and quarterly updates..

Acting Assignment – 6 months - Issues Manager• Authoring and coordinating of action items through the Management of Executive Correspondence System (MECs). - Requests for Briefing Notes or Speaking Notes for the ADMO, DMO, or MO.- Inquiries and letters of concern written to the Minister of Health from Canadian citizens and stakeholders concerning various initiatives organized by the Bureau of Nutritional Sciences (Ex. Sodium reduction, Trans Fat reduction, Menu Labelling). • Drafting of MS Power Point Presentations (DECK) for Executive’s presentations.• Coordinating and compiling “Look Ahead” documents that reflect the bureau’s upcoming publications, meetings, presentations, and consultations.• Assisted in the facilitation of two Strategic Planning Sessions.• Management of a general email account for the bureau: authoring or coordinating a response from various FD staff and emailing a response to the inquiry.

Acting Assignment (BI-04) – 4 months - Project Lead: Screening Team of the 2012 Food-NHP Transition Team• Facilitated the transfer of approximately 700 hard copy files from the Natural Health Products Directorate (NHPD) to the Food Directorate (FD) with a team of 3 colleagues.• Coordinated the screening of over 400 hard copy files with a team of 9 colleagues within a short deadline. Evaluators were to document screening findings within an MS Excel spreadsheet identifying specific nutrients, ingredients, health claims, and product representation. • Organized and coordinated the data migration (data entry) of ~200 files into an Excel spreadsheet (~ 5 staff).• Coordinated and compiled the results of various stakeholder communication initiatives (“Call Out Blitzes”) for over 200 products and over 75 stakeholders with a team of 11 colleagues. Project objective was achieved: as no inquiries were made (by these stakeholders) to the Assistant Deputy Minister’s Office.- Products with ingredients making the product ineligible for a Temporary Marketing Authorization (TMA) under the Food and Drug Regulations Act.- Products that may have an ingredient (Food Additive) rendering the product ineligible.- Consulting Energy Drink Product stakeholders on their options in transitioning from the NHPD to the FD.- Contacted companies of 103 Products to inform them of the transition between the NHPD and the FD of HPFB.

Summary: Experience as a Scientific Evaluator completing Pre-Market evaluation of scientific/regulatory information. Work experience included an acting assignment as a CH-04 making final decisions on Product License Applications. Had involvement within a compliance initiative that managed the risk of a NHP through implementing subjective quality standards. Drafted risk management policy documents.Product Licence Assessment:• Safety & Efficacy and Quality assessments (scientific evaluation) of Natural Health Product Licensing submissions. Consistently exceeded performance benchmarks for assessments.• Provided training to colleagues, and prepared summarizing training documents.Drafted and researched Pre-Cleared Information documents for NHPD’s assessment of product’s containing Taurine or Fish Oil:• Investigated and researched various topics (with assistance from assigned Co-op students)• Prepared drafts of the Pre-Cleared Information document for Taurine and monograph for Cod Liver Oil which outlines NHPD’s health risk assessment on the medicinal ingredients, and its corresponding “Research on Monograph” document (recording the decision).Acting Assignment (CH-04) – Quality Advisor – Oct 20-24th 2008.• Reviewing Quality Reports from Assessment Officers and providing commentary and/or final approval for a Product License under the Natural Health Products Regulations.Compliance – Misidentification of Black Cohosh:• Compiled and reviewed scientific information for NHPD’s Compliance unit and NHPD management: associated with the risk issue for the use of mis-identified raw materials being sold as the medicinal ingredient Black Cohosh.

Productivity Reporting:Summary: Assisted in the production of productivity reports for NHPD’s product licensing.• Completed ad hoc reports and searches within various relational databases.• Advanced manipulation of MS Excel for data mining and creation of presentation documents.

"Food-like Natural Health Product (NHP) steering group" assignment – Preparation of an action plan for pre-market submissions:Summary: Steering group team member to facilitate the Food Directorate's and Natural Health Product's Directorate’s regulatory framework for “Food-like NHPs”. Completed various policy related initiatives within short deadlines.• Conducted verification of received submissions. Coordination with NHPD staff in transferring Product Licence Submissions.• Maintained an inventory of files. Interim tracking system development.• Involved in the development of documents, which included advice from legal services. • Attended inter-directorate meetings."Modernization Project" – Project Support Team assignment. Part of the “Blueprint for Renewal” initiative. Project is intended to modernize and improve the pre-market submission management processes for the Food Directorate:Summary: Worked with the management of the five Food Directorate bureaux to bring forward project documents and initiatives. Provided contributions within a project team to progress action items (through the Health Canada’s Decision-making framework process).• Coordination and progress monitoring skills. Diplomatically resolved issues during conflicts. Used negotiation skills to provide solutions with internal government contacts to address identified problems.• Research of best practices from other organizations and development of improvement options.• Assistance in tracking system, key performance indicator and work plan development.• Involved in other initiatives: process mapping, obtaining legal counsel, web-posting.

Summary: Prepared Clinical Trial Applications for Therapeutics Products Directorate (TPD), Biologics & Genetic Therapies Directorate (BGTD) and Natural Health Products Directorate (NHPD). Preparation of post approval documents to maintain compliance. Coordination of documentation with various involved staff.• Project manager: maintained 30-40 sponsors as workload of clients. Filed upward to 50 CTAs or CTA Amendments working within a small regulatory team (3-4 colleagues). Able to obtain Health Canada approval for 100% of submissions filed.• Provided consulting on interpretations of the Canadian regulations, and maintain compliance with the Food and Drug Regulations. • Communicated with Health Canada's contacts to resolve product/submission concerns.• Was involved in a client anticipatory compliance audit for their product (self-audit).• Prepared and completed performance presentation to upper management (however, based on sales and marketing analysis).• Attended and represented CanReg Inc. at various regulatory organization meetings (ex. CAPRA)

• Coordinated information from various scientific bureaux (the tracking of policy development, Public Involvement calendar, Genomics Initiative proposals from the Food Directorate, etc…).• Completed research for the Director and Senior Policy Officers.• Drafted documents for consideration to management.

Bureau of Microbial Hazards – Policy DivisionAssisted in the revision of several Health Canada policies (sprouts, smoked fish, fish roe and caviar, and extraneous materials):• Drafted text and made edits.• Exposed to food biology and the study of pathogenic organisms. • Completed research into topics, evaluated risk reports from the Canadian Food Inspection Agency. Compiled information, and drafted policy revisions for management consideration.