A comprehensive overview of US regulatory affairs for biologics and pharmaceuticals, this workshop will benefit individuals who are new to intermediate level in the regulatory profession or preparing for the RAC (US) examination. Presented will be an overview of regulations, guidance and policy affecting strategic product development and US regulation of biologics and pharmaceutical products. Quality, nonclinical and clinical fundamentals in the investigational and registration phases will be discussed as they pertain to different product modalities; Various regulatory development and registration pathways will be covered. A brief survey of advertising, labeling and promotional aspects of marketed products will be presented; along with post-approval, compliance and enforcement requirements. Course includes interactive breakout mirroring today’s development challenges.
Program Date: 12-13 November 2019
Meeting Location:
Regulatory Affairs Professionals Society HQ Office
5635 Fishers Lane, Terrace Level
Rockville, MD 20852
Registration Closes: 8 November 2019
Refund Deadline: 13 October 2019
RAC Credits: 12 RAC recertification credits upon completion of the program
Will this meeting be recorded? No
Proof of Attendance: An electronic letter of attendance will be sent upon request.
Registration Fees
Registration to 14 October
MEMBER: $1,050
NONMEMBER: $1,150
Registration from 15 October to 5 November
MEMBER: $1,150
NONMEMBER: $1,250
Advance registration is required for this workshop. Participants are encouraged to register early. RAPS will not accept onsite registrations for this in-person workshop.
Objectives
At the conclusion of the workshop, participants should be able to:
- Understand the US regulations, guidance, and precedence for development and registration of pharmaceuticals and biopharmaceuticals
- Understand preparation of, content and format of IND/NDA/BLA
- Define and incorporate key regulatory development strategies into the appropriate product development phases
- Understand requirements of IND/NDA/BLA, amendments and supplements
- Comprehend the regulatory review processes and formal sponsor agency interactions
- Understand the prescription drug labeling and advertising promotion requirements
- Appreciate the criticality of established conditions in the CMC module of your registration and how to advance this during product development leveraging ICH Q8 – Q12
Who Should Attend
Regulatory affairs professionals who are new or intermediate level in their regulatory career who want a deeper understanding of the investigational and/or product registration process.
Agenda Day One:
- Bringing Your Program through Development
- Basic Concepts of Regulatory
- Overview of Nonclinical in Research and Development
- Quality Essentials in Research and Phase 1 and 2
- Case Study: Are you ready for an IND?
- Summary of Day
Agenda Day Two:
- Bringing Your Program through Registration and into Post-Approval
- Quality Essentials in Phase 3/Registration and post-approval
- Phase 3 Clinical Development
- Introduction to Case Study Group Breakout: You have problems – when to engage the regulators
- Case Study Workshop: Presentations and Discussion
- Advertising, Promotion and Labeling Essentials
- Panel discussion
NOTE: Program content may vary
Faculty
- Alan McEmber, Head, Rare Disease Global Regulatory Affairs, Takeda
- Kristin Murray, CEO and Managing Partner, Contemporary Tenets Regulatory Consulting
- Ruth Turner, Lead, Neuroscience and Ophthalmology, Global Regulatory Affairs, Takeda
IMPORTANT: Participants are encouraged to register early. Onsite registrations are not accepted.
Registration Online Registration Form (PDF) for registration by mail or fax If it is your preference, please use the registration form to register by mail, email or fax. A RAPS online account will be created to complete your purchase if you are not a member or past customer.
Questions? Call RAPS Solution Center at +301.770.2920, ext. 200.
Refund Deadline: 13 October 2019
Other Information
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.
Program Contact
Nichelle Sankey
nsankey@raps.org
+301 770 2920, ext. 291
Parking
Paid parking is available in the parking garage directly behind 5635 Fishers Lane in Rockville (next door to US Pharmacopeial Convention).
Area Airports
Ronald Reagan Washington National Airport (10 miles)
Washington Dulles International Airport (36 miles)
Baltimore-Washington International Airport (37 miles)
Area Hotels
Even Hotel Rockville (Walking Distance)
1775 Rockville Pike
Rockville, MD 20852
Reservations: +1 877 834 3613
Hilton Washington DC/Rockville Hotel (Walking Distance)
1750 Rockville Pike
Rockville, MD 20852
Reservations: +1 301 468 1100
Bethesda North Marriott Hotel
701 Marinelli Road
Bethesda, MD 20852
Reservations: +1 301 822 9200
Bethesda Marriott Suites
6711 Democracy Boulevard
Bethesda, MD 20817
Reservations: +1 800 228 9290
Washington Metro Access
The Twinbrook Metro Station is a short walk to 12601 Twinbrook Parkway. Take the Red Line to the Twinbrook Metro Station.
All cancellation requests must be submitted to raps@raps.org by 13 October 2019. RAPS is unable to accept cancellations by phone. Please specify the name of the person registered and event title. A 20% cancellation fee will be assessed.
Substitutions may be accepted with written approval from RAPS, and must be submitted to raps@raps.org by 29 October 2019.
If you have questions or concerns, please contact RAPS customer service at +301 770 2920, ext. 200, or via email at raps@raps.org.
NOTE: RAPS reserves the right to request additional documentation in making determinations regarding cancellations and refunds. Refunds will be granted solely at the discretion of RAPS.
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