Electronic Regulatory Landscape: Current Trends and Upcoming Opportunities.

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June 1, 2023 from 8:30am to 4:00pm EDT

Toronto

May 26, 2023, at 5:18 pm.

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The CAPRA Symposium Committee will host a face-to-face meeting on the Electronic Regulatory Landscape: Current Trends and Upcoming Opportunities, to share updates with our members on eCTD V4, eCTAs, XML PM, REP, and other key aspects of the electronic regulations.

This event will be of interest to:

Regulatory Affairs professionals from pharmaceuticals/biologics, medical devices, as well as veterinary drugs
Clinical Research and Contract Research Organizations
Clinical Data Management/Pharmacovigilance
Research and Development

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CAPRA Symposium Committee

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Speakers / Panelists

Katerina Paschakis

Business Informatics Division, Health Products and Food Branch
Health Canada
Katerina Paschakis

Business Informatics Division, Health Products and Food Branch
Health Canada

Katerina Paschakis is the acting Associate Director of the Business Informatics Division in the Health Products and Food Branch. She provides strategic and operational leadership for the implementation of HPFB’s IT investment plan and governance. Katerina was previously Manager of the Project Portfolio Management Office in the same division.

Since joining Health Canada in 2011, Katerina has worked with both internal and external partners in a range of capacities including regulatory affairs, senior advisor to the Assistant Deputy Minister, operations, and project management.
Khaled Yahiaoui

Associate Director, Regulatory Affairs - Operations
Merck Canada Inc.
Khaled Yahiaoui

Associate Director, Regulatory Affairs - Operations
Merck Canada Inc.

Khaled has spent the last 12 years of his regulatory career in refining his experience in regulatory operations management and was constantly involved in initiatives pertaining to the shaping of the future of e-regulations in Canada. He holds the position of Associate Director, Regulatory Affairs – Operations, at Merck Canada and is a lecturer at Université de Montréal in charge of the course on electronic submissions and regulations. Khaled also holds a Regulatory Affairs Certification from RAPS and master’s degrees in Drug Development, Biochemistry and Computer Science.
Irena Pastorekova

Business Informatics Division, Resource Management and Operations Directorate
Health Canada
Irena Pastorekova

Business Informatics Division, Resource Management and Operations Directorate
Health Canada

Irena Pastorekova has worked at Health Canada since 2006. Currently she supervises operational group at Business Informatics Division, whose responsibility is dossier ID issuance, support to industry, validation and automation of eCTD and non-eCTD submissions received via the electronic gateway. She is involved in policy development, roll-out of new projects and a member of M8 ICH working group.
Jennifer Kutlesa

Regulatory Operations Manager
Bayer Inc.
Jennifer Kutlesa

Regulatory Operations Manager
Bayer Inc.

Jennifer Kutlesa is Senior Manager of Regulatory Operations at Bayer Inc. with over 35 years’ experience in the Pharmaceutical industry. From the start she has been an advocate of advancing to use of XML, eCTD and beyond within Bayer as well as industry overall having led BIOTECanada as well as IMC Technical Groups to enhance implementation and collaboration on all things technical. In addition, she is passionate about inclusion of all users of our product information taking a strong interest in accessibility for all and availability of public electronic information.
Mike Kurktschi

Senior Specialist, Regulatory Affairs – Operations
Merck Canada Inc.
Mike Kurktschi

Senior Specialist, Regulatory Affairs – Operations
Merck Canada Inc.

Mike holds a B.Sc. in Biology with a minor in Computer Science from Concordia University. Mike has more than 11 years of experience in electronic regulatory activities including eCTD, regulatory systems, data and information management as well as regulatory process improvement. Mike joined Merck Canada in 2019 and holds the position of Senior Specialist, Regulatory Affairs - Operations. During the last four years, he implemented multiple automation initiatives to optimize regulatory information uptake and workflows.
Charles Mathis

Regulatory Solutions Architect
LORENZ Life Sciences Group
Charles Mathis

Regulatory Solutions Architect
LORENZ Life Sciences Group

Charles has worked in different roles for LORENZ at intervals since 2007, including QA and Development roles. He has had various roles, including QA and Development. Today he focuses on internal strategic technical planning and platform architecture, as well as providing consulting for agencies and other similarly complex customers. He has worked in various types of regulated environments since 1989 and designed and implemented his first electronic regulatory filing system using structured content in 2003. He participated in the early implementation of FDA's SPL and designed a supporting authoring system. In addition, he has been IT Manager for a regulatory agency and an Enterprise Architect with major Canadian banks. In his spare time, he likes to sing with his champion Barbershop chorus, the Toronto Northern Lights.
Tracy E. Brown

Senior Project Manager, Business Informatics Division, Health Products and Food Branch
Health Canada
Tracy E. Brown

Senior Project Manager, Business Informatics Division, Health Products and Food Branch
Health Canada

Tracy Brown as worked at Health Canada in the regulatory environment since 2000. She started her career at the Pest Management Regulatory Agency before joining the Health Products and Food Branch, where she has worked for most of her career. Tracy has worked in regulatory roles in both the Biologic and Radiopharmaceutical Drugs Directorate and the Pharmaceutical Drug Directorate. She participated in many regulatory projects and led the guidance document revisions for related to the CTD and eCTD formats. Tracy is currently a Senior Project Manager within the Resource Management and Operations Directorate’s Business Informatics Division, where she has successfully led several major projects. Tracy assumed the lead of the XML PM project in 2020.
Anh Tran

Manager, Regulatory Submission Management Organization
Janssen Inc.
Anh Tran

Manager, Regulatory Submission Management Organization
Janssen Inc.

Anh Tran is a Manager, Regulatory Submission Management Operations at Janssen with over 20 years of experience in Regulatory Affairs, Quality and Compliance. Anh currently leads the compilation of Canadian regulatory submissions and works to optimize regulatory operations at Janssen.
Anh is passionate about the work that she does and is known for her ability to navigate complex regulatory strategies to achieve efficient filing solutions. Anh has been engaged in the XML PM project for the last 8 years, collaborating with Health Canada and leading an Industry discussion group to advance this initiative and promote a balanced regulatory approach while improving the accessibility of drug product information for Canadians.
Anh is excited to share her industry experience and journey on the XML PM project at the CAPRA Symposium.
Cynthia Martel

Senior French Labelling Specialist, Linguistic Services
Janssen Inc.
Cynthia Martel

Senior French Labelling Specialist, Linguistic Services
Janssen Inc.

For over 10 years, Cynthia has been pursuing a career as a bilingual scientific reviewer at Janssen Inc. where she oversees the translation of product labelling into French. Cynthia holds a B.Sc. in Biology, a B.A. in Translation and 10 years of clinical experience as a paramedic, and is a certified translator member of the Association of Translators and Interpreters of Ontario. Cynthia recently took on the role of coordinator for the migration of product monographs to the HC Master Template and the XML conversion projects. She co-leads the IMC XML working group with other Janssen colleagues and liaises with the Industry Translation Network. Driven by her passion for equal opportunities she takes pride in working towards a future where all Canadians will have quick and easy access to accurate information in both official languages.
Gary Saner

Sr. Information Manager
Reed Tech Life Sciences
Gary Saner

Sr. Information Manager
Reed Tech Life Sciences

Gary Saner is a Sr. Manager of Information Solutions in the Reed Tech Life Sciences group and is a subject matter expert on Drug Labeling, Medical Device UDI, and other structured content reporting to regulatory agencies and commercial organizations. He has over 35 years of experience in the areas of software development, process management, and data administration with the last 15 years focused on the Life Sciences industry. With an understanding of regulations, business requirements, and systems, he has helped shape and implement successful solutions at Reed Tech for data management, validation, and processing of Drug Labeling content and Medical Device UDI data. He serves as chair of the industry’s Structured Product Labeling (SPL) Technical Team and on the Advisory Board of the Medical Devices Group.
Amanpreet Kainth

Team Lead, Regulatory Affairs and Services
i4i Inc
Amanpreet Kainth

Team Lead, Regulatory Affairs and Services
i4i Inc

Amanpreet Kainth is an accomplished Regulatory Affairs specialist, having worked with structured documents for over 10 years and providing regulatory services for global pharmaceutical companies. She is a well renowned industry speaker and leader in the health products industry specializing in labelling of pharmaceutical drugs, biologics, OTC, medical devices, natural health products, cosmetics, etc. As the Regulatory Services Team Lead at i4i Inc., Aman coordinates and manages varied projects. Aman received her B.Sc. in Biotechnology from the University of Toronto & Punjabi University. She also holds a post-degree certification in Pharmaceutical Regulatory Affairs & Quality Operations from Seneca College.
Maggy Mouradian

Manager, Regulatory Policy & Operations
Boehringer Ingelheim (Canada) Ltd.
Maggy Mouradian

Manager, Regulatory Policy & Operations
Boehringer Ingelheim (Canada) Ltd.

Maggy is Manager, Regulatory Policy and Operations for Boehringer Ingelheim (Canada) Ltd. a global family-owned and innovative pharmaceutical company. Maggy is known for her insightful leadership and change advocacy work at local and global levels to ensure high-quality results are delivered in line with business priorities. Prior to joining Boehringer, Maggy provided regulatory and project management compliance at Sandoz Canada and Apotex, giving her deep experience in the generics space. Maggy has an MSc in Chemistry from Concordia University and is an ICF certified coach helping pharmaceutical leaders bring their vision to life.