US Regulatory Essentials, Pharmaceuticals

6.0
RAC Credits
Virtual Programs
Wednesday, 17 November 2021 (9:00 AM) - Wednesday, 17 November 2021 (5:30 PM) Eastern Time (US & Canada)

Providing a thorough overview of laws, regulations and guidance affecting strategic product development and US regulation of biologics and pharmaceutical products, this workshop is tailored for individuals who are new to intermediate level in the regulatory profession or preparing for the RAC Drugs examination. 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.

 

Agenda

    Workshop Overview
  • Basic Concepts of Drugs and Biologic Regulation: Regulatory/Legal Framework
  • Nonclinical Essentials
  • CMC Essentials: IND and considerations for Phase 1 and 2; Considerations for Phase 3, Registration and Post-Approval
  • CMC Development Scenarios
  • IND Essentials: Early Clinical Development (Phase 1 & 2) and IND Process
  • Late-Stage Clinical Development and NDA/BLA Process; Post Approval Considerations
  • Drug Safety Essentials
  • Labeling Essentials
  • Advertising and Promotion Essentials

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.

Pricing Amounts & Deadlines 

21 June 2021 - 16 October 2021: Early Bird $480.00 Member | $540.00 Nonmember

17 October 2021 - 11 November 2021: $540.00 Member | $600.00 Nonmember

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.


Speaker

Grace Chiou, PhD
Grace Chiou is a regulatory professional and drug developer with more than 25 years of pharmaceutical industry experience in discovery, gene cloning and regulatory affairs, including more than 12 years of combined experience in global regulatory strategy and submission, global regulatory labeling, advertising and promotion, and team leading experience for countries and regions including the US, EU, Japan, Canada, Taiwan, and China. Chiou joined Takeda in November 2019. She has previously worked with Shire, Baxalta, Abbott, and Eli Lilly in early- and late-stage pipeline development for drugs and devices. She earned a master’s degree in pharmacy administration and a PhD in public health from the University of Illinois, Chicago, and a master’s degree in biology from Rensselaer Polytechnic Institute.


Kristen E. Heinlein, PharmD
Kristen E. Heinlein has more than 15 years of experience in the pharmaceutical industry, having spent the past 10 years in various leadership roles in advertising and promotion regulatory. She has been with Takeda for 16 years, where she is currently vice president of US advertising and promotion regulatory. Prior to joining the regulatory team, Heinlein held various positions of increasing responsibility in medical communications at Shire, which also included an international assignment. Prior to entering the pharmaceutical industry, she was a clinical/staff pharmacist at Peninsula Regional Medical Center in Salisbury, MD.





Maria Iacovelli
Maria Iacovelli is a regulatory professional with more than 20 years of pharmaceutical industry experience in chemistry, manufacturing and controls (CMC) for development and commercial products. Prior to joining Takeda through the acquisition of Shire Pharmaceuticals, she was the regulatory affairs CMC head for the team responsible for Shire’s small molecule portfolio of development and commercial products. Iacovelli was a director of RA CMC at Cubist Pharmaceuticals until shortly after Merck acquired Cubist. She started her RA CMC career at Genzyme Pharmaceuticals, where she managed the team responsible for Genzyme’s renal portfolio. Iacovelli has led several programs and teams through the drug approval process at Genzyme, Cubist and Shire, including breakthrough therapies (BTDs) and a Qualified Infectious Disease Product (QDIP).


Sunil Kadam, PhD
Sunil Kadam is a regulatory professional and drug developer with more than 34 years of pharmaceutical industry experience in discovery, translational medicine and regulatory affairs. He joined Telix in June 2020. Kadam has previously worked with Abbott, Eli Lilly, Quintiles/IQVIA and Shire/Takeda in early- and late-stage pipeline development for drugs, devices, and diagnostics. He has global regulatory submission and team leading experience for countries and regions including the US, EU, Japan, Canada and China. He has led teams working with FDA advisory committees and secured FDA approval. Kadam earned master’s and PhD degrees in fermentation technology and enzymology from University College, Dublin, Ireland. He trained as a postdoctoral fellow in microbial genetics at the University of Calgary, Canada, and in biotechnology and molecular engineering at the Massachusetts Institute of Technology.



Alan McEmber, Takeda
Alan McEmber has over 30 years of experience in the pharmaceutical and device industry. He has broad international and domestic regulatory and product development experience from discovery, through development, to market approval and lifecycle management. Alan’s broad experience encompasses drugs, biologics, and devices in several therapeutic areas, including immunology, oncology, pulmonary, hematology, metabolism/endocrinology, inborn errors, antiviral, cardiovascular/renal, neuroscience, rheumatology, and dermatology.



Kaity Posada, PharmD
Kaity Posada, PharmD, is currently a senior director of global regulatory affairs at Takeda Pharmaceuticals. She has more than 20 years of experience in small molecule and biologic drug development with broad US and international experience. She has led programs and teams in both clinical development and regulatory affairs functions across various therapeutic areas, such as neuroscience, cardiovascular, pulmonary, and rare diseases. Posada has led various interactions with health authorities, and regulatory submissions and approvals in US, EU, Japan, and Latin America.





Cancellation Policy

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. 

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

RAPS will send an electronic letter or a certificate of attendance at the following the workshop.


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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