Indiana Chapter Webcast- Regulatory Impacts of Temperature Sensitive Products and UK Medical Device Regulation Changes

2.0
RAC Credits
Chapter Events Chapter Events
Thursday, 10 March 2022 (12:00 PM) - Thursday, 10 March 2022 (2:00 PM) Eastern Time (US & Canada)

Member: $0
Nonmember: $25


What to Know to Keep from Getting Burned 

 An increasing proportion of drug products are biologics or other temperature-sensitive preparations. And, the truth is, all drugs are temperature-sensitive to some extent. Regulators now have expectations for data to support the storage and shipment of such drugs. Attend this event to learn the data requirements and when regulators expect the data during a drug development.  

A live Q&A portion with the speaker will follow the presentation.

This event is brought to you by RAPS Indiana Chapter to encourage knowledge sharing and community development. RAC holders may claim 2.0 RAC recertification credits.

Audience Learning Level

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.

RAPS membership provides vital information for regulatory professionals and a place for networking and invaluable connections. Now is a great time to explore the many benefits to RAPS membership, including the Member Knowledge Center and our award-winning, private online community, Regulatory Exchange. Find out more about RAPS membership today.

 

How Do Webcasts Work?

For the best webcast experience, please use the Google Chrome browser. RAPS webcasts are also mobile- and tablet-accessible for your convenience. Registrants will receive instructions on how to log in 24 hours before the start of the webcast. A live Q&A portion with the speakers will follow the presentation. 

Learning Objectives

After this program, participants will understand the data types needed to support the storage and shipment of temperature-sensitive drug products and when regulators expect the different kinds of data in the development cycle. 

Who Should Attend? 

Anyone working on the development of a temperature-sensitive drug. And all drugs are temperature-sensitive to some extent. This includes Technical, Quality and Regulatory folks. 

  • Vulnerability management 
  • Incident response 
  • Breakout: tabletop exercise: “You’ve been hacked! Now what?” 
  • Supply chain 
  • Musical chairs: Who’s typically responsible for different aspects of a security program? 

Instructors:

 

Bob Seevers is an independent consultant with more than 40 years of experience in pharmaceutical research and development. After more than a decade in nuclear medicine, he spent eight years with the US Food and Drug Administration (FDA) as a reviewer and team leader, followed by 16 years with Eli Lilly and Company in quality assurance and regulatory affairs. He also served as a senior regulatory advisor with Pearl Pathways for several years. Seevers has led the regulatory Chemistry, Manufacturing and Controls (CMC) submission strategy for drugs in preclinical development through submission and the approval process for both small and large molecules. His expertise includes cold chain shipping, stability, determining regulatory starting materials, radiopharmaceuticals, setting global specifications, determining product critical quality attributes, quality by design (QbD), global regulatory submissions, and interactions with regulatory agencies. His knowledge spans the therapeutic areas of central nervous system, endocrine, metabolism, autoimmune, oncology and more. He has spoken at numerous conferences and has served as a World Health Organization (WHO) invited lecturer. Seevers earned a PhD in medicinal chemistry from the University of Michigan.

Natalie McRoberts

Natalie McRoberts has worked with medical devices and in vitro diagnostic (IVD) products for more than 26 years as a test engineer, medical device designer, and regulatory and industry executive. She was head of notified body for two different notified bodies covering the EU’s Medical Devices Directive, IVD Directive and Active Implantable Medical Devices Directive. McRoberts served as secretary of the European Association of Notified Bodies and participated in establishing principles and requirements for notified body conformity assessment. She is an experienced auditor for ISO 13485 and device regulatory quality management systems (QMS) programs, including CMDCAS, European Notified Body, Japan 3rd Party Program and MDSAP. As a member of the CMDCAS regulators forum, she helped transition the Canadian regulatory program to MDSAP. She was a member of the International Accreditation Forum Working Group on ISO 13485 and medical devices QMS, helping to establish accreditation requirements. McRoberts also has served on numerous technical committees, working groups and task forces on QMS, risk management and other medical device standards.

Thank you to our Platinum Chapter Sponsors:




Event Policies

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. 

Registration fees for this event are nonrefundable. 

Paid registration substitutions may be accepted with written approval from RAPS for requests received within 48 hours of the start of the event. To transfer a registration, email support@raps.org with the event title, name of the original registrant and the contact information for the new attendee. 


Questions

Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email support@raps.org  

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