Creating new product labeling and content for package inserts is always a challenging task in the drug development process.
Labeling documents are the only ones visible to the end users. Development of labeling requires regulatory intelligence expertise to ensure the inclusion of information that is appropriate to ensure the safe and effective use of the product and compliance with regulatory requirements.
Join us at this virtual event to learn how you can make sense clinical study data and information available elsewhere to create a package insert that meets the regulatory requirements and serves the end user.
Registration Fees & Deadlines
Present – 16 November 2024: Early Bird Member $150 | Nonmember $175
17 November 2024 – 17 December 2024: Regular Member $175 | Nonmember $200
Learning Objectives
- Define the labeling process and requirements and cross-functional leadership requirements for labeling development
- Demonstrate the use of competitive labeling intelligence for the creation of labeling documents, such as Company Core Data Sheet, USPI, SmPC etc.
- Describe labeling requirements as they apply for various countries
Who Should Attend?
Regulatory professionals who are involved in the drug development process.
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.
Speakers
Kamana Singh, DVM, MBA, PSM, RAC-US
Executive Consultant, APS Pharma Solutions, LLC
Kamana Singhis a regulatory labeling consultant professional with about 15 years of experience in the pharmaceutical industry. She is the founder and executive consultant of the consulting company APS Pharma Solutions, LLC. Kamana has experience consulting for companies such as Johnson & Johnson, Pfizer, Sanofi, Takeda, and several small and mid-sized pharmaceutical companies. She has an academic background with a doctorate in veterinary medicine, a master's in animal biotechnology, regulatory affairs, and business administration. Singh earned her Regulatory Affairs Certification in 2008. She is a member of the RAPS San Francisco chapter and is vice president for education for the Regulatory Affairs Toastmasters Club.
Cancellations and Refunds
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. All cancellation requests must be submitted in writing to support@raps.org. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.
Substitutions
Paid registration substitutions may be accepted with written approval from RAPS for requests received before 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.
Proof of Attendance
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
Questions
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email
RAPS@raps.org