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Bethesda North Marriott Hotel and Conference Center

2025 年 02 月 03 日 7:00 上午 - 2025 年 02 月 05 日 3:00 下午

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Regulatory Submissions, Information, and Document Management Forum

Don't miss the latest trends, innovations, and best practices in regulatory submissions, information, and document management (RSIDM)!

Call for Abstracts Expires






Jillian E. Carinci, MS

Jillian E. Carinci, MS

Senior Director, Head of Submission Sciences, Biogen, United States

Jillian Carinci is Sr. Director, Head of Submission Sciences group at Biogen. Jillian leads Biogen’s Global Delivery Managers and is responsible for overseeing global submissions, establishing processes, ensuring compliance, robust submission planning, tracking metrics, high quality submission delivery and process improvements. Jillian began her career at Octagon Research Solutions before transitioning to Accenture. During her tenure at Accenture Jillian partnered with sponsors to manage numerous regulatory submission projects, ensuring compliance with global regulatory requirements, delivering within scope, on time, and with the highest quality.

Cary  Smithson, MBA

Cary Smithson, MBA

Managing Partner, Leapahead Solutions, Inc., United States

Cary Smithson is the Senior Director, Business Transformation and Systems Management at PharmaLex and has over 30 years of experience helping life science Regulatory, Clinical and Quality organizations drive increased productivity, streamline information management and enhance regulatory compliance. Her areas of expertise include regulated content and information management, regulatory information management, eTMF, GxP quality / compliance, IT strategy, business process optimization, Agile and project / program management. Cary co-leads the DIA RIM Working Group, leads the DIA RIM Intelligent Automation Topic Team, contributes to the RIM and EDM Reference Models and led the development of the DIA GMP Quality Systems Reference Model.

Sandra  Krogulski, MA

Sandra Krogulski, MA

Director, GRSO Innovation and Business Operations Lead, Bristol-Myers Squibb Company, United States

Sandy Krogulski is an experienced and solution oriented individual with over 10 years of submission experience. Sandy joined BMS in 2018, working on global submissions and process evolution. In her current role, Sandy is focusing on digitalization and automation of processes to improve submission strategy and business operations.

Cindy  Chiu

Cindy Chiu

Senior Director, Regulatory Affairs Operations and Quality Management, Merck & Co., Inc., United States

Cindy Chiu is a Senior Director in Global Regulatory Affairs and Clinical Safety group at Merck & Co. She has over 20 years of experience in the pharmaceutical and energy industries, focusing on post-merger process integration and operations excellence. She has served in various leadership roles overseeing project management, business process improvement and change management initiatives. In her current role at Merck & Co., she is the Lead of the Regulatory Content Authoring and Archiving Management group. Prior to Merck, she worked as a management consultant, where she assisted clients with change management and business process redesign as a result of merger activity or technology integrations.

Jonathan  Resnick, PMP

Jonathan Resnick, PMP

Project Management Officer, OBI, OSP, CDER, FDA, United States

Jonathan Resnick is a member of CDER’s Division of Data Management Services and Solutions, with a focus on eCTD and has been with FDA for 13 years. Prior to joining FDA, Jonathan spent 18 years working in IT project management supporting federal and private sector clients.

Rita  Algorri, PhD, MS

Rita Algorri, PhD, MS

Senior Manager, Global Regulatory Affairs (CMC), Amgen, United States

Rita Algorri, PhD is a Senior Manager, Regulatory Affairs CMC at Amgen Inc. in Thousand Oaks, CA. In this role, her responsibilities include leading and orchestrating internal and external engagement activities relating to regulatory modernization, digitization, automation, and emerging technologies. She also serves within Amgen’s Advocacy and External Engagement function which fosters collaboration with multiple internal and external cross-functional teams to coordinate and progress company and industry initiatives. Rita is a microbiologist by training and holds a PhD in Clinical and Experimental Therapeutics and M.S. in Regulatory Science from the University of Southern California.

Jennifer  Dames

Jennifer Dames

Director, RA Submission Management, Abbvie, United States

Jennifer Dames is Director, Regulatory Submissions at AbbVie. She has over 10 years experience in Regulatory. Jennifer has experience with implementation of a Regulatory Information Management system, Document Management, Submission Management, Publishing, and system support.

Lindsey  Fitzgerald

Lindsey Fitzgerald

Senior Consultant, Astrix, United States

Regulatory Affairs Business Solution expert with proven industry experience in project management, advisory services, business analysis and business support of the Department. With her 10 years’ experience at AstraZeneca leading Regulatory IT projects, spanning business/technology analysis, project management, validation/testing, business training development and delivery she has credibility speaking with both IT and Regulatory business stakeholders. As an end-to-end RIM process data and system expert with 7 years’ experience in Regulatory consulting for top pharma clients she has led business process optimization, RFP and vendor selection, implementation, and migration projects.

Dominik  Gigli

Dominik Gigli

Management Consultant, Main5 GmbH & Co. KGaA, Germany

Dominik Gigli is a senior expert in Regulatory Information Management and IDMP with 10+ years in the pharmaceutical industry driving the digital transformation in Regulatory Affairs. With his strengths drawing the big picture and vision towards data driven regulatory submissions and particular understanding of the steps and obstacles how to get there, Dominik is helping Life Science transform their organization to a digital future. Before joining MAIN5 in 2022, Dominik was working in several leading positions in Regulatory Operations focusing on RIM, IDMP, Data Management, Data Governance Data Quality, Reporting and Analytics in Merck Healthcare and Fresenius Kabi.

Shenqi (Handsome)  Ji

Shenqi (Handsome) Ji

Regional Publishing Lead, Asia, Global Regulatory Operations, Pfizer, China

Handsome Ji has rich experience in sharing Electronic Common Technical Documents (eCTD) knowledge on many conferences of domestic and international. In 2016, Handsome was invited to China Regulatory Summit as an industry specialist and advisor for eCTD Symposium. In early 2018, Handsome was nominated to a consultant of Regulatory Affairs of Young Member of Advisory Committee (YMAC), DIA, as well as Taskforce co-Lead for DIA China RA Community. From 2015 to 2023, Handsome has chaired sub-forums of ICH Theme Day of DIA China Annual Meetings and DIA China M4/M8 Workshops and presented topics about Regulatory Operation.

Jared  Lantzy, PMP

Jared Lantzy, PMP

Executive Director, Global Regulatory Operations, Novavax, Inc., United States

Kunal  Lal

Kunal Lal

Consultant - Strategy & Change, Red Nucleus, United Kingdom

Kunal Lal is a UK-based Consultant with Red Nucleus and a subject matter expert in Regulatory Information Management and IDMP/XEVMPD. He has over 13 years of experience working across the Regulatory, Pharmacovigilance, Clinical and Supply Chain functions of pharmaceutical organizations, with robust knowledge of related regulations, processes, and systems. Kunal has led and contributed to many projects for regulatory readiness, process assessment, definition and optimization, data maturity assessment and governance and application support and maintenance.

Sarah  Pope Miksinski, PhD

Sarah Pope Miksinski, PhD

Executive Director, CMC Regulatory Affairs, Gilead Sciences, United States

Sarah Pope Miksinski has been with Gilead since July 2023 and is currently an Executive Director in CMC Regulatory Affairs. She represents Gilead in various external capacities In 2021, she was appointed as the PhRMA Topic Lead for ICH M4Q(R2) and was appointed to the ISPE Board of Directors in 2022. She concurrently serves as the Rapporteur of the ICH Quality Discussion Group (QDG). Previously, Sarah served at AstraZeneca for over 5 years, holding roles in the CMC Regulatory Affairs space. Prior to that, she held a lengthy tenure at FDA, lasting from 2002-2018.

Daniel  Offringa

Daniel Offringa

Principal Consultant, eSub Solutions, United States

Dan Offringa has regulatory career spanning over thirty years. For the past 20+ years he has worked in the electronic submissions field for both the FDA and industry, including guidance promulgation, standards and process development, and system implementation. He is the owner of eSub Solutions, an electronic publishing consultancy, and has been responsible for thousands of submissions to multiple regulatory authorities. Dan holds a bachelor of science degree from Duke University.

Nimesh  Patel

Nimesh Patel

Director of Global Regulatory Systems & Operations, Eisai Pharmaceuticals, United States

Director of Global Regulatory Systems, overseeing the implementation, support and development Eisai's Regulatory technology strategy. Active member of IRISS and Committee Member in PhRMA's Regulatory IT Workstream. Prior to Eisai, performing similar roles in supporting the Regulatory functions at Big Pharma, Consultancies and mid-size biotech's for the past 20+ years.

Vladimir  Penkrat, MBA

Vladimir Penkrat, MBA

Associate Vice President – Regulatory Affairs, Indegene, United States

Vladimir Penkrat is AVP of Regulatory Affairs at Indegene. With an MBA in International Business, Vladimir has provided strategic leadership throughout his career across R&D functional areas including clinical development, biometrics, biostatistics, medical writing, pharmacovigilance, and regulatory affairs. Over the past three decades Vladimir has experience in top pharmaceutical, biotech startups, CROs, and consulting firms. Vladimir's leadership has enabled clients’ businesses to prepared and adapt to the evolving digital landscape and prepare for changes. As a business leader he has scaled business operations greater than 500 FTE in size globally to deliver services across the R&D landscape.

Noelia  Plaza

Noelia Plaza

Director of Process Excellence & Analytics, Daiichi Sankyo, United States

Theresa   Pinnell

Theresa Pinnell

Director of Regulatory Solutions, Kivo, United States

Theresa has over 20 years of experience in the life sciences industry, where she has developed and delivered innovative and user-friendly solutions for regulatory, clinical and QA processes. She is currently the Director of Regulatory Solutions at Kivo, a company that provides a unified cloud-based platform for managing regulatory activities and content, TMF and QMS documents. She is passionate about empowering emerging life science groups to accelerate their research and development and bring their products to market faster and safer. She fosters a culture of inclusion and collaboration within teams, leveraging her diverse background in library and information science, business and her global experience with various pharmaceutical clients.

Maria  Sagoua, MHA

Maria Sagoua, MHA

Director of Regulatory Innovation, Accumulus Synergy, United States

Maria Barhams Sagoua joined Accumulus Synergy as Director, Regulatory Innovation where she is responsible for translating regulatory requirements into practice within the Accumulus Platform. Prior to joining the Accumulus team, Maria served as SAS’ Principal Consultant to the U.S. FDA where she was responsible for partnering with the Agency to advance digital transformation goals across regulated products.Throughout her career, Maria has worked across the biomedical research (NIH), regulatory (FDA), technology (DrFirst) and clinical (Kaiser Permanente) ecosystem to support the design, development, and delivery of innovative solutions. Maria holds a BS-Biology from Ball State University and MHSA from the George Washington University.

Seyoum  Senay, MS

Seyoum Senay, MS

Supervisory Operations Research Analyst, CDER/OBI, FDA, United States

Mr. Senay is a visionary leader with a focus on innovation and positive change. At the heart of his mission is the widespread adoption of cutting-edge Informatics solutions, aimed at ensuring the availability of safe, effective, and new medicines for patients. As a U.S Excellence in Government Leadership Fellow, Mr. Senay is recognized for his excellence in delivering impactful results. Holding a master's degree from The Johns Hopkins University and being a Certified Program Manager, he brings extensive knowledge and expertise to advance the FDA CDER mission.

Matthias  Sijtstra

Matthias Sijtstra

Senior Data Management Specialist, Celegence Netherlands, Netherlands

Matthias works as a Senior Data Management Specialist for Qdossier, a Celegence company. The focus of his work is Data Management, where he provides consultancy and subject matter expertise for implementation of Regulatory Information Management (RIM) solutions and compliance projects (e.g. IDMP/DADI). In these projects, he is looking to gain more for the client than just compliance, by engaging people, processes, and tools, he is working to improve the client's data quality. Additionally, Matthias has experience in software development and validation in a highly regulated environment.