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The highly-anticipated fifth edition is here! Get the must-have resource for achieving compliance with medical device regulations.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
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
18 November 2020 – 9 May 2021: Early Bird $480.00 Member | $540.00 Nonmember
10 May – 2 June 2021: Regular $540.00 Member | $600.00
affairs professionals who are new or intermediate level in their regulatory
career who want a deeper understanding of the investigational and/or product
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 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, TakedaAlan 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.
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