Electronic Regulatory Landscape: Current Trends and Upcoming Opportunities.
June 1, 2023 from 8:30am to 4:00pm EDT
May 26, 2023, at 5:18 pm.
If you registered online for the event, please ensure that you have received a link to join from customercare@gotowebinar.com.
To avoid any connection issues on the day of the event, make sure to check the system requirements beforehand. In case you cannot find the invite in your inbox, kindly check your Junk/Spam folder.
Restricted Join: Please note that the event has a restricted join policy, meaning that each attendee can only join using a single device. Switching between devices during the event may cause delays.
For any further inquiries, please contact the CAPRA administrator at administrator@capra.ca.
See the brochure for registration information and sponsorship opportunities.
Please Note: Hotel rooms under the CAPRA group rate are limited; book by May 4, 2023.
Last Call: Rooms are subject to availability – make your reservation by May 4, 2023, via the link in the brochure. Book your group rate.
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
Please share the news of this event within your organization.
CAPRA Symposium Committee
PLEASE NOTE: A link to our event platform will be provided for those joining remotely after the registration has closed.
Registered attendees will receive an official link to the Symposium Online via Go To Webinar.
Please ensure that your system meets the requirements to avoid connection issues on the event day.
If there are any unexpected interruptions, such as a power outage, log back in, and the event will resume from where it was disconnected.
Speakers / Panelists
-
Katerina Paschakis
Business Informatics Division, Health Products and Food Branch
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
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
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
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
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
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
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
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
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
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
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
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.
Sponsors
Platinum Event Sponsorship
Gold Event Sponsorship
Payment Options
The two options for payment are as follows:
- Credit card payment online
- Third-party payment via credit card
Please note: Under the new incorporated CAPRA, credits for meetings can no longer be issued. In order to attend a meeting, payment must be received prior to the meeting registration deadline. Registrants for whom payment has not been received will be refused entry to the meeting.
Process
Add the registration option to your cart. After completing the checkout process, you will be provided with a link to the Event Registration form(s) where you can provide us with the details of the attendee(s). If you have registered for previous events, then you can simply confirm your previously submitted details, or make changes where needed.
Registration is now closed