CAPRA 2024 Pharmaceutical SYMPOSIUM

Details Download to Calendar Speakers / Panelists Downloads Sponsors

October 22, 2024 from 7:15am to 4:35pm EDT

Westin Toronto Airport,
950 Dixon Road,
Toronto, Ontario

Registration is now open for the CAPRA 2024 Pharmaceutical Symposium until October 17, 2024.

2024 Pharmaceutical Symposium Banner

CAPRA will host this one-day pharmaceutical symposium with Health Canada and Industry leaders. This unparalleled collaborative event will provide a unique opportunity to hear from Health Canada and industry leaders. You will also gain new regulatory insights through in-person panel discussions from all speakers from the following areas:

Opening remarks from the Director General of PPD, Health Canada
Overview of the roles of IMC and CGPA in supplying high-quality prescription medicines
Updates from the Bureau of Pharmaceutical Sciences
Negative Decision Analysis - Quality
Labelling Deficiencies Observed in Drug Submissions
Comprehensive Drug Shortage Update
Latest Nitrosamines Update

Please see the 2024 Symposium brochure for your registration, hotel reservation deadline information and sponsorship opportunities.

We encourage you to attend the event in person and share this news with your regulatory colleagues and within your organization.

CAPRA Symposium Committee

Registration Deadline: Thursday, October 17, 2024, 4:00 p.m.
*Registrants may be substituted, but no refunds will be issued after the deadline.
*Disclaimer: CAPRA reserves the right to amend the conference (including but not limited to speakers' identities, topics, locations, and the timing of speakers) without notice to you. If the conference is canceled for any reason whatsoever, such reason not within the control of CAPRA, CAPRA shall not be liable for any cost or loss otherwise incurred.

**Update: This Symposium will be hosted using Go To Webinar.**

Event Registration Form: Please provide your first name, last name, and the email address you intend to use to log in on the day of the Symposium.
Registered attendees will receive an official Go To Webinar link to join the Symposium after the Registration deadline.
Please ensure that you check the system requirements to avoid any connection issues on the day of the event.
In case of unexpected interruptions, such as a power outage, please log back, and Symposium will restart from where it was disconnected.

Speakers / Panelists

Karen Reynolds

Director General, Pharmaceutical Drugs Directorate (PDD), Health Canada.
Health Canada.
Karen Reynolds

Director General, Pharmaceutical Drugs Directorate (PDD), Health Canada.
Health Canada.

Karen Reynolds is the Director General of the Pharmaceutical Drugs Directorate (PDD) in the Health Products and Food Branch (HPFB) of Health Canada. In this role, she oversees the review and approval of drug submissions seeking authorization to be sold on the Canadian market.

Karen has spent the majority of her over 25 years in public service, in different roles at Health Canada. Within PDD, she has also previously served as the Director of the Bureau of Pharmaceutical Sciences from 2013-2016, where she was responsible for the regulatory review of submissions for generic drugs.

Before rejoining PDD as Director General in September 2022, Karen held executive positions at the Canadian Food Inspection Agency (CFIA) and Health Canada’s Strategic Policy Branch. This included a leadership position in 2018-2019 in the Secretariat for the Government’s Advisory Council on the Implementation of National Pharmacare.

Karen holds a Bachelor of Science degree in Pharmacy from the University of Toronto and a Master of Business Administration degree from the Ivey Business School at Western University and has practiced in both hospital and retail pharmacy.
Kristin Willemsen

Vice President, Scientific and Regulatory Affairs, Canadian Generic Pharmaceutical Association.
Canadian Generic Pharmaceutical Association.
Kristin Willemsen

Vice President, Scientific and Regulatory Affairs, Canadian Generic Pharmaceutical Association.
Canadian Generic Pharmaceutical Association.

Kristin Willemsen is the Vice President of Scientific & Regulatory Affairs for CGPA. She works with CGPA members advocating for implementing regulatory, policy and guidance changes to increase access to safe, effective, and affordable generic medicines for Canadians. A key part of her role as an industry association professional over the past 15 years has been developing productive, collaborative relationships with governments and stakeholders to drive impactful regulatory outcomes. Kristin is also a Certified Association Executive and has earned an MSc from the University of Ottawa.
Lama Abi Khaled

Executive Director, Ethics, Legal and Regulatory, Innovative Medicines Canada
Innovative Medicines Canada
Lama Abi Khaled

Executive Director, Ethics, Legal and Regulatory, Innovative Medicines Canada
Innovative Medicines Canada

Lama Abi Khaled joined Innovative Medicines Canada in April 2018. She is responsible for regulatory, legal and ethics and integrity matters within IMC.

Lama holds a Biochemistry degree, a master’s in business administration (MBA) and a Juris Doctor (J.D.) from the University of Ottawa. Prior to obtaining her J.D., Lama worked for over 10 years in pharmaceutical pricing and market access, both in the private and public sectors.

Before joining IMC, Lama was an In-House Legal Counsel and Compliance Officer. She also worked at a national Intellectual Property firm in Ottawa and completed her clerkship at the Federal Court of Canada.
Chris Rose

Director, Bureau of Pharmaceutical Sciences, PDD, Health Canada
Health Canada
Chris Rose

Director, Bureau of Pharmaceutical Sciences, PDD, Health Canada
Health Canada

Chris comes to us from the Pharmaceutical Drugs Directorate, where he is the Director of the Bureau of Pharmaceutical Sciences.

Prior to joining BPS, he was in the Controlled Substances and Cannabis Branch, where he was the Director of Branch Operational Support Services. In this role, he was accountable for developing, implementing, supporting and continually improving Branch-wide business management frameworks, including HR, finance, planning, IM/IT and employee engagement. Prior to this role, he was the Director of Program Implementation for the Cannabis Legalization and Regulation Secretariat, in which he oversaw the implementation of the government's initiative to legalize and regulate cannabis. He was also the Director of Operations for the Office of Medical Cannabis and was responsible for the compliance and licensing of cannabis producers and registrations for the personal production of cannabis for medical purposes.

Before joining the public service, Chris worked in the private industry on biologics and medical device product development and at the provincial healthcare level on organ and tissue donation and transplantation.
Dr. Susan Lum

Generic Drug Quality Division Manager, PDD, Health Canada.
Health Canada
Dr. Susan Lum

Generic Drug Quality Division Manager, PDD, Health Canada.
Health Canada

Dr. Susan Lum is a Manager within the Bureau of Pharmaceutical Sciences, Pharmaceutical Drugs Directorate, Health Products and Food Branch, Health Canada. She serves as Health Canada’s topic lead and member of ICH’s Implementation Working Group (IWG) for ICH Q13 Continuous Manufacturing of Drug Substances and Drug Products. Dr. Lum, a Canadian-qualified pharmacist, earned her B.Sc.Phm., M.Sc. in polymers and controlled drug delivery and her Ph.D. in pharmaceutics at the University of Toronto. Before joining Health Canada, she was employed within the pharmaceutical industry at several companies, including Patheon Inc. (now Thermo Fisher), providing technical and strategic oversight on new drug projects with challenging molecules and on new technologies and platforms. Dr. Lum is the author or co-author of several peer-reviewed research papers, abstracts, a patent and a book chapter (Drugs and the Pharmaceutical Sciences series). She served on the American Association of Pharmaceutical Scientist’s Pediatric Formulation Task Force. Her international expertise was previously recognized with the Ebert Prize, co-sponsored by the Journal of Pharmaceutical Sciences and the American Pharmaceutical Association.
Veronica Yip

Labelling Division Manager, Pharmaceutical Drugs Directorate (PDD), Health Canada
Health Canada
Veronica Yip

Labelling Division Manager, Pharmaceutical Drugs Directorate (PDD), Health Canada
Health Canada

Veronica Yip joined Health Canada in 2001. She is currently the Manager of the Labelling Division in the Pharmaceutical Drugs Directorate (PDD), responsible for the pre-market evaluation of labelling materials submitted for pharmaceutical prescription drugs in accordance with the Food and Drug Act and its Regulations and the implementation of the Plain Language Labelling (PLL) Regulations. She also manages PDD’s Administrative Submissions Unit (ASU), which screens submissions filed through the administrative pathway. She previously held various regulatory positions in the former Therapeutic Products Directorate (TPD), including Screening Officer and Label Reviewer in the Bureau of Pharmaceutical Sciences, Senior Regulatory Project Manager and acting Manager of the Regulatory Project Management Division.
Stephanie Trapani

Director of the Operations Division, Health Products Shortages Directorate, Health Canada
Health Canada
Stephanie Trapani

Director of the Operations Division, Health Products Shortages Directorate, Health Canada
Health Canada

A graduate of Dalhousie University, Stephanie Di Trapani joined Health Canada in 2005. In 2020, she became the Director of the Drug Shortages Division, Health Product Compliance Directorate within the Regulatory Operations and Enforcement Branch (ROEB). In April 2024, the Drug Shortages Division transitioned into the newly formed Health Products Shortages Directorate. Stephanie is now the Director of the Operations Division, which includes oversight for drug and medical device shortages.

Previously, Stephanie oversaw compliance and enforcement activities for human, veterinary, and natural health products at ROEB and held several roles at the Health Products and Food Branch.
Mina Tadrous

An Assistant Professor at the Leslie Dan Faculty of Pharmacy, University of Toronto
University of Toronto
Mina Tadrous

An Assistant Professor at the Leslie Dan Faculty of Pharmacy, University of Toronto
University of Toronto

Mina is an assistant professor at the Leslie Dan Faculty of Pharmacy at the University of Toronto and the Tier 2 Canada Research Chair in Pharmaceutical Policy and Real-world Evidence. He is also co-director of Pharmaceutical Policy and Pharmacy Practice at the Ontario Drug Policy Research Network (ODPRN) and ICES adjunct scientist. Mina leads research focused on evaluating drug policies and post-marketing surveillance of medications. He works closely with policymakers and uses large data sets to answer questions about real-world safety and effectiveness and improve the optimal use of medications.
Stephen Horne

Senior Scientific Evaluator/Nitrosamine Subject Matter Expert, Quality Risk Management and Operations Division, BPS, PDD,
Health Canada
Stephen Horne

Senior Scientific Evaluator/Nitrosamine Subject Matter Expert, Quality Risk Management and Operations Division, BPS, PDD,
Health Canada

Stephen earned a Ph.D. in organic chemistry from the University of Waterloo (ON) in 1991 and completed postdoctoral research at Stanford University (CA, USA). He has held industrial positions in drug discovery (Syntex Canada), drug substance process research and development and management (ACIC, Brantford Chemicals), and later Vice-President Global Scientific and Regulatory Affairs (Apotex Pharmachem). He is named as an author or inventor on more than 45 peer-reviewed publications and patents and has held adjunct professor appointments with Western University and the University of Waterloo. In 2018, he was elected a Fellow of the Chemical Institute of Canada. He joined Health Canada as a Senior Scientific Reviewer, supporting Health Canada’s task group, managing and responding to the risks associated with nitrosamine impurities in pharmaceuticals. He has contributed to the international regulatory guidelines ICH Q2, Q3C, Q9, Q11, Q13, and Q14.
Alisa Vespa

Senior Scientific Evaluator/Nitrosamine Safety Subject Matter Expert, Office of Risk Management Division, BMS, PDD,
Health Canada.
Alisa Vespa

Senior Scientific Evaluator/Nitrosamine Safety Subject Matter Expert, Office of Risk Management Division, BMS, PDD,
Health Canada.

Alisa Vespa joined Health Canada in 2006. She worked for several years as a Senior Evaluator in the Bureau of Metabolism, Oncology and Reproductive Sciences, evaluating non-clinical data for new drug submissions. Alisa is part of the Risk Management Division within the Bureau of Medical Sciences, working on nitrosamine impurities in pharmaceutical products. Alisa co-chairs the Nitrosamines International Technical Working Group, representing Health Canada on the ICH’s M7 and S1 expert working groups. Alisa holds a Ph.D. in Pharmacology and Toxicology from Western University.
Martin Ehlert

Vice President, Global API R&D, Apotex Inc.
Apotex Inc.
Martin Ehlert

Vice President, Global API R&D, Apotex Inc.
Apotex Inc.

Martin Ehlert obtained a B.Sc. in Applied Chemistry at McMaster University and a Ph.D. in Chemistry at the University of British Columbia. In 1994, Dr. Ehlert commenced his career in the pharmaceutical industry at Phytogen Life Sciences, working in API process development, engineering, and production operations. In 1998, he joined Apotex Pharmachem Inc., serving in various capacities within API R&D and operations. In 2015, Dr. Ehlert moved to Apotex Inc. and currently holds the Vice President of Global API R&D role.
Oliver R. Thiel

Member of EFPIA ICH M7 EWG
Oliver R. Thiel

Member of EFPIA ICH M7 EWG

Dr. Oliver Thiel serves as vice president of process development and operations commercialization at Amgen, a department that leads the delivery of operations' product strategies and commitments for commercialization. He will join the speakers on the panel for the Q&A session on nitrosamines.

Oliver joined Amgen in 2003 and has held various positions in Process Development, most recently serving as Associate vice president of drug Substance Technologies Synthetics. In this position, he supported the clinical and commercial process development and commercialization of the Amgen synthetic portfolio, including peptides, oligonucleotides, and bioconjugations. His teams have been accountable for commercial process development, technology transfers, commercial support for commercial products, and clinical development candidates.

Oliver has authored more than 50 publications and presented at international conferences. He serves on the ICH M7 Expert Working Group and has been engaged in workstreams from the American Chemical Society and the IQ consortium. Prior to joining Amgen, Oliver was a postdoctoral fellow at Stanford University. He has an M.Sc. degree in chemistry from the Technical University Munich and a Ph.D. from the Max-Planck-Institut für Kohlenforschung. He also holds a business degree from the Fernuniversität Hagen.