
XN 2021 Test Event
Become a Sponsor and/or Exhibitor
Registration Options
Individual Registration
Group Registration
Event information coming soon.
Promotions and Press
Request Press Pass
Submit Your InformationLocation and Travel
Venue Details and Accommodations
PLEASE READ PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.
Registration
Pricing Options
More information coming soon.
GROUP REGISTRATION DISCOUNT: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.
GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.
CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].
Presenters
Meet the Experts
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Atul J Agrawal, MS
U.S. FDA
Supervisory Consumer Safety Officer, OPQO, ORA
Regulatory Panelist
Read Bio -
Maria C.H. Anderson, MS
U.S. FDA
Branch Chief, Biological Drug and Device Compliance Branch, OCBQ, CBER
Regulatory Panelist
Regulatory Presenter
Read Bio -
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Denyse D. Baker, PE, RAC
Eli Lilly and Company
AVP Global Quality Compliance
Panelist
Presenter
Read Bio -
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Robert M Barbosa
U.S. FDA
Drug Specialist and Pre-Approval Manager, OMPTO, ORA
Regulatory Panelist
Read Bio -
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Tara Gooen Bizjak, MBS
U.S. FDA
Director, Manufacturing Quality Guidance and Policy Staff, OC, CDER
Moderator
Regulatory Panelist
Regulatory Presenter
Read Bio -
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Ashley B Boam, MSBE
U.S. FDA
Director, Office of Policy for Pharmaceutical Quality, OPQ, CDER
Regulatory Panelist
Regulatory Presenter
Read Bio -
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Cindy L. Burnsteel, DVM
U.S. FDA
Deputy Director for Drugs and Devices, OSC, CVM
Regulatory Panelist
Regulatory Presenter
Read Bio -
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Patrizia Cavazzoni, MD
U.S. FDA
Director, Center for Drug Evaluation and Research
Regulatory Panelist
Regulatory Presenter
Read Bio -
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Alicia D Collins
Bristol Myers Squibb
Senior Director, Cell Therapy Global Product Supply Planning and Management
Panelist
Presenter
Read Bio -
Conor C. Collins, PhD, MBA, MSc
GlaxoSmithKline
Head of Validation/PLM for Pharma Supply Technical
Presenter
Read Bio -
Carl-Helmut Coulon, PhD
INVITE GmbH
Head of Future Manufacturing Concepts
Panelist
Presenter
Read Bio -
Darrin J Cowley, PhD
AstraZeneca
Vice President Head of Developmental Quality, Biologics
Panelist
Presenter
Read Bio -
Alonza E. Cruse
U.S. FDA
Director, Office Pharmaceutical Quality Operations, ORA
Regulatory Panelist
Regulatory Presenter
Read Bio -
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Pamela C De Moor, MS, PhD
Vir Biotechnology, Inc
Senior Director, Formulations and Drug Product Development
Panelist
Presenter
Read Bio -
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Mary E. Farbman, PhD
Merck & Co., Inc.
Associate Vice President, Global Quality Compliance
Moderator
Read Bio -
Travis A Frick, MSc
Biologics / Cell & Gene Therapy Manufacturing
Manufacturing & Quality Operations Leader
Panelist
Presenter
Read Bio -
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Francis RW Godwin, MBA
U.S. FDA
Office Director, OMQ, OC, CDER
Co-Chair
Moderator
Regulatory Panelist
Regulatory Presenter
Read Bio -
Dennis E Guilfoyle, MS, PhD
Johnson & Johnson
Senior Director, Microbiology Regulatory Compliance
Panelist
Presenter
Read Bio -
Maria T Gutierrez Lugo, PhD
U.S. FDA
Supervisory Chemist, CDER
Regulatory Panelist
Regulatory Presenter
Read Bio -
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Brooke K. Higgins, MS
U.S. FDA
Branch Chief, OC, CDER
Regulatory Panelist
Regulatory Presenter
Read Bio -
Peter J Hotez, MD, PhD
Baylor College of Medicine
Dean National School of Tropical Medicine
Panelist
Presenter
Read Bio -
Patricia F Hughes, PhD
U.S. FDA
Senior Scientific Advisor, OPQ, CDER
Moderator
Regulatory Panelist
Regulatory Presenter
Read Bio -
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Mike G Labruto, MS
University of Pennsylvania/Gene Therapy Program
Executive Director
Moderator
Read Bio -
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Michele Lastro, MS, PhD
Regeneron Pharmaceuticals, Inc.
Executive Director
Panelist
Presenter
Read Bio -
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Matthew A. Lucia, DVM
U.S. FDA
Director, Office of New Animal Drug Evaluation, CVM
Regulatory Panelist
Read Bio -
Nicholas F Lyons, MS
U.S. FDA
Director of Compliance, Office of Pharmaceutical Quality Operations, ORA
Regulatory Panelist
Read Bio -
Ingrid Markovic, PhD
U.S. FDA
Senior Science Advisor, Office of the Center Director, ORO, CBER
Moderator
Read Bio -
Peter W. Marks, MD, PhD
U.S. FDA
Director, Center for Biologics Evaluation and Research
Regulatory Panelist
Regulatory Presenter
Read Bio -
Judith A McMeekin, PharmD
U.S. FDA
Associate Commissioner for Regulatory Affairs, ORA
Regulatory Panelist
Regulatory Presenter
Read Bio -
John M McShane, MBA
Lachman Consultant Services, Inc.
Vice President, BIologics
Panelist
Presenter
Read Bio -
Melissa J. Mendoza, JD
U.S. FDA
Director, OCBQ, CBER
Regulatory Panelist
Regulatory Presenter
Read Bio -
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Kevin J O'Donnell, PhD
Health Products Regulatory Authority
Market Compliance Manager
Presenter
Regulatory Panelist
Read Bio -
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Erika A. Pfeiler, PhD
U.S. FDA
Supervisory Microbiologist, Office of Pharmaceutical Manufacturing Assessment, OPQ, CDER
Regulatory Panelist
Regulatory Presenter
Read Bio -
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Simone E. Pitts, MS
U.S. FDA
National Expert, Pharmaceutical, ORA
Regulatory Panelist
Regulatory Presenter
Read Bio -
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Mahesh R. Ramanadham, PharmD, MBA
CDER/OPQ/US FDA
Deputy Director
Regulatory Panelist
Regulatory Presenter
Read Bio -
Emabelle Ramnarine, PhD
Boehringer Ingelheim
Executive Director, Product Management & Development Operations
Panelist
Presenter
Read Bio -
Sabrina Restrepo, PhD
Merck & Co., Inc.
Executive Director - Quality Assurance
Panelist
Presenter
Read Bio -
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Dr. Carmelo Rosa
U.S. FDA
Division Director, Office of Manufacturing and Product Quality, OC, CDER
Regulatory Panelist
Regulatory Presenter
Read Bio -
Abriana Rozentsvayg, MA
Pfizer
Director Packaging Project Engineering, GTS Packaging and Device SVCS
Co-Presenter
Read Bio -
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Susan J. Schniepp
Regulatory Compliance Associates Inc.
Distinguished Fellow
Moderator
Panelist
Presenter
Read Bio -
Kimberly LW Schultz, PhD
U.S. FDA
GTB CMC Reviewer, CBER
Regulatory Panelist
Regulatory Presenter
Read Bio -
Melissa S. Seymour, MBA
Eli Lilly and Company
EVP and Chief Quality Officer
Panelist
Presenter
Read Bio -
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Douglas R. Throckmorton, MD
U.S. FDA
Deputy Director of Regulatory Programs, CDER
Regulatory Panelist
Regulatory Presenter
Read Bio -
Weida Tong, PhD
U.S. FDA
Director, Division of Bioinformatics and Biostatistics, NCTR
Regulatory Panelist
Regulatory Presenter
Read Bio -
Alex M. Viehmann
U.S. FDA
Division Director, OPQ, CDER
Regulatory Panelist
Regulatory Presenter
Read Bio -
Nicholas A Violand
Johnson & Johnson
Director, Enterprise Regulatory Compliance
Regulatory Panelist
Regulatory Presenter
Read Bio -
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Ravi Yalamanchili, MS, MBA
Merck & Co., Inc.
Executive Director Global Quality
Panelist
Presenter
Read Bio
Sponsors
Sponsors and Collaborators
Exhibitors
Exhibitors and Innovators
Attendee List Email Scam
Unfortunately, emails are circulating that offer to sell attendee lists for many of PDA's conferences and events. These emails are sent by scammers.
Note: PDA does not sell its exhibitor or attendee lists, and no third-party is authorized to distribute or sell any lists related to our events. Statements claiming to offer our attendee lists are fraudulent. If you receive emails that propose to sell PDA conference attendee lists, do not engage with the sender and delete the message immediately.
Media Partners
Trusted Media Collaborators
Become a Sponsor and/or Exhibitor
Amplify Your Presence and Reach Your Customers!
Become a Sponsor
Elevate your brand and maximize your exposure by becoming a sponsor at the XN 2021 Test Event! Connect with industry leaders, showcase your products and services, and establish your company as a key player in the field.
Request InformationBecome an Exhibitor
Boost your brand and visibility by becoming an exhibitor at the XN 2021 Test Event! Connect with industry influencers, showcase your products and services, and position your company as a key player in the field.
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