30 January 2019
12:00 – 1:00 pm EST
Implementing an end-to-end Regulatory Information Management (RIM) solution can have significant impacts on your short term and long-term regulatory processes. Join this webcast to hear IONIS’ Christie Hamel and United Therapeutics’ Hilary Hafeken describe their experiences with implementing a unified RIM solution.
These presenters will cover process improvements and lessons learned in submission management, health authority interactions and reporting, followed by a Q&A session with the live audience.
Basic: Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher level activities.
Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.
Upon the webcast's conclusion, you will be able to:
Who should attend?
- Identify which regulatory processes are most critical to a successful end-to-end implementation
- Optimize submission planning, tracking and health authority interaction management
- Leverage workflows to streamline regulated content management and improve quality
- Utilize reports to increase transparency and visibility across the organization of key regulatory events and activities
- Plan for an effective data and document migration
Professionals involved in:
Christie Hamel, director of regulatory operations, IONIS Pharmaceuticals
- Business and/or IT leads for regulatory systems
- Regulatory personnel responsible for coordinating with regional offices or local affiliates
- Anyone involved in implementing or expanding global systems
Christie Hamel is the director of regulatory operations at Ionis Pharmaceuticals where she has lead the group for the past eight years. Prior to her time at Ionis, Hamel managed regulatory operations teams at Datafarm Inc. and PAREXEL. Over the years, she has enjoyed implementing new software, submission formats and processes. The company has embraced eCTD submissions, two different eCTD building software systems, word templates and Electronic Document Management System (EDMS) processes.
Hilary Hafeken, director of regulatory informatics, United Therapeutics
Hilary Hafeken is director of regulatory informatics at United Therapeutics. With over 15 years' experience in the pharmaceutical industry, she has successfully implemented four EDMS and three electronic publishing systems. Hafeken’s successes include leading the change from paper to electronic submissions and transitioning to a cloud-based solution.
Ginny Smith, associate manager of regulatory informatics, United Therapeutics
Ginny Smith has been a regulatory professional since 2002 and has over ten years’ experience working with electronic regulatory submissions. She has been at United Therapeutics for seven years. During her time with UT, she has worked on numerous Investigational New Drug (IND) and New Drug Application (NDA) submissions, spearheaded her group’s management of an original Marketing Authorization Application (MAA), Biologics License Application (BLA), and NDS. She has also contributed as a member of the teams implementing a new Document Management System, publishing tool and Regulatory Information Management system.
Rachel Belani, director of Vault RIM, Veeva
Rachel Belani has 14 years of experience in the pharmaceutical industry. She is currently a member of the global regulatory strategy team at Veeva. Before joining Veeva, Belani’s career was focused on developing solutions and processes for life sciences organizations, with a specific focus on regulatory, clinical and safety. She started off her career at Actelion Pharmaceuticals where she served as the Americas lead for R&D systems and processes, including ECM/EDMS, archiving, CTMS, LMS, ERP, analytics and reporting for clinical development. Following Actelion, Belani transitioned into a consulting role where she helped life science companies define and optimize their business and solution architecture, from both a clinical and regulatory perspective.