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Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
21 December 2021 - 28 January 2022: Early Bird $495.00 Member | $580.00 Nonmember
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.
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.
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.
Anne Gilson
Anne Gilson is a scientific professional with a diversified background of more than 15 years in research and pharmaceutical product development, including toxicology and formulation. She excels at taking on multiple, changing priorities in support of studies, successful product approval and market launch. Gilson leverages her in-depth experience with drug regulatory filings and quality control, and offers strong technical writing and project leadership skills along with a keen ability to coordinate across internal and external groups for on-time completion.
While Alan will not be speaking at this event, he was a vital contributor to RAPS in putting on this workshop.
Alan McEmber, Takeda
Alan McEmber has more than 30 years of experience in the pharmaceutical and medical device industries. He has broad international and domestic regulatory and product development experience—from discovery through development to market approval and lifecycle management. McEmber’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.
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.
RAPS will send an electronic letter or a certificate of attendance at the following the workshop.