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.
Learning Levels
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.
Learning Objectives
Upon the webcast's
conclusion, you will be able to:
·
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
Who
should attend?
Professionals involved in:
- 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
Speakers
Christie Hamel, director of
regulatory operations, IONIS Pharmaceuticals
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.