Bala heads VB Insights, an advisory firm for the Healthcare and Life Sciences sector. Bala brings over 35 years of experience. During his long tenure, he has been responsible for the introduction of Web, document management, global team collaboration, and regulatory information management applications to large pharma. Until recently, Bala was Head of the Healthcare and Life Sciences Industry Solutions Group at Orion Innovation. As an entrepreneur and a thought leader, he has been involved in initiatives to transform regulatory affairs from a document-centric function to a data-driven function. Bala has been associated with DIA for more than 14 years, most recently as the DIA RIM Working Group subteam lead for the RIM Reference Model.

Brooke is known for her pivotal roles in collaborating with Sponsor Companies, Health Authorities, and Technology Developers. She has maintained focus on leveraging cutting-edge technologies as a catalyst for regulatory advancements, optimization, and collaboration for global go-to-market strategies and data harmonization. She was named PharmaVoice’s top 100 most inspiring individuals for Mentorship and Team Development and received the esteemed Excellence in Service award from DIA. Brooke has an integral role in shaping the discourse surrounding data and technology in regulatory affairs through her work with DIA as programming chair for the Data & Technology Track and as the co-chair of the DIA RA Community.

Michelle Charles, MPH is the Director of Regulatory Affairs in the Gene Therapy Program at the University of Pennsylvania, Perelman School of Medicine, providing guidance on global regulations, submission support and strategic regulatory planning. She co-chairs the DIA RSIDM Conference and has participated as a committee member for several years. Before joining the University of Pennsylvania’s Gene Therapy Program Michelle held multiple positions at both Merck & Co., Inc. and PAREXEL International. During her time in industry Michelle focused on regulatory operations, project management and business process development for global regulatory information management. Michelle holds a Masters of Public from Johns Hopkins University.

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.

Jake Doran is currently the Head of Digital @ MAPS Public Benefit Corporation. In this role, Jake is responsible for overseeing the development and implementation of the digital and IT strategy as the MPBC organization transitions from a clinical research startup to a commercial entity and industry pioneer. Prior to joining MPBC, Jake was the Head of Global R&D IT at Bausch Health. Jake prides himself in being a biologist by study and a technologist by trade and throughout his career has positioned himself at the intersection of science and technology. Earlier in his career, Jake held positions of increasing responsibility at Genpact, Janssen Pharmaceuticals and Schering Plough.

Sholeh is an internationally known TMF Subject Matter Expert with over 15 successful years of experience in the Clinical Research Industry. Her experience includes the TMF Reference Model Subject Matter Expert, eTMF management, domestic and international pharmaceutical and biological clinical trials, clinical trial management, site selection, vendor relations, electronic document management, regulatory submissions, quality control processes and implementation and regulatory inspection preparation and participation. She is currently Principal Consultant and President and CEO of LMK Clinical Research. She is also the Facilitator for the Metrics Champion Consortium's (MCC) TMF initiative.

Ron Fitzmartin is Senior Informatics Advisor, Office of Regulatory Operations, Center for Biologics Evaluation and Research, Food and Drug Administration. In this role Ron provides policy and strategy consultation and support on a wide range of topics focused on electronic regulatory submissions and standardized data. Some of Ron’s activities include: chair of the PDUFA VI information technology committee, Regulatory Chair of the ICH M11 Expert Working Group on the standardized clinical protocol template, and chair of the IDMP Working Group under the International Pharmaceutical Regulators Programme. Ron received a PhD in statistics from the University of Maryland and MBA from University of New Haven.

Mark has over 30 years’ experience in Information Technology & Management. Mark began his career developing commercial applications and has been working for FDA for over 30 years. Mark’s FDA responsibilities have included software development and project management in CBER; Director of Applications Development & Services in CDER; PDUFA IT Program Director; Director, Division of Data Management Services & Solutions managing CDER’s electronic submission program, and ICH M8 (eCTD) Rapporteur. Mark has been with CBER's data standards group since 2014, and his current responsibilities include representing CBER in the development and implementation of international electronic submission standards.

Ginny serves as Chief of CBER's Data Standards Branch, where she leads a multidisciplinary team that advances standards such as eCTD, CDISC, IDMP, ICSR, SPL and related terminologies. In addition, conducts technical validation of clinical study data, leads related reviewer training, and industry outreach. She is co-Chair of the FDA Data Standards Advisory Board and FDA Topic Lead for the ICH M2 Electronic Standards EWG. Ginny has worked in informatics at FDA since 2004, previously serving as Director, Data Management Services and Solutions in OBI/CDER. She developed CDER’s electronic submissions and reviewer training program, encompassing eCTD and CDISC Standards and well as contributing to the 745A binding guidances.

Joanne Malia is Director, Development Records Management at Regeneron Pharmaceuticals and responsible for the TMF group and Clinical Archives and is the Business Process Owner for the eTMF. Throughout her 25+ year career in life sciences she has worked for diagnostic, biotech, pharmaceutical companies and CROs. She serves on the CDISC TMF Reference Model Steering Committee, on the organizing committee for DIA’s Regulatory Information Document Submission Meeting and presents frequently at industry conferences.

Thomas is a 20+ year experienced leader in Pharmaceutical, Diagnostic and Medical Device Regulatory Affairs, Electronic Publishing and Document Management. He has a strong track record of successful regulatory interactions and filings, resulting in the approval of over 25 new drugs, devices and diagnostics. He has worked for a number of organizations both in the Consulting and CRO industry, as well as on the sponsor side of the equation. He has developed services and led global teams resulting in the consistent delivery of high-quality output aligned with business needs. Some of Thomas’s skills include regulatory process and workflow excellence, eCTD publishing, document management, commercial regulatory, and computer systems validation.

Dan is a Leadership professional with 20+ years experience in Regulatory Submission production. A subject matter expert for eCTD & EDMS solutions. A business process analyst for submission assembly and eCTD publishing. He’s been a key member of several industry/agency initiatives for electronic submission standardization & efficiency. Dan has presented or chaired sessions at DIA Annual Meeting & DIA RSIDM/EDM Conferences. He's a DIA RSIDM Conference Program committee member. Dan established/directed eCTD publishing groups at Merck & Co., Inc. & Datafarm Inc. (leading eCTD software & services provider). At Teva, Dan led a initiative to harmonize the publishing environment into a single tool set (EDMS, eCTD Publishing etc.).

Sarah Powell is the President of Powell regulatory Services. Sarah has over 35 years of experience in pharmaceutical and related regulated industries. Sarah has worked as an independent consultant assisting clients with projects related to process improvements, standards development, and implementation of new technology. While in industry, Sarah performed roles within the Clinical, Quality, Regulatory Affairs and Regulatory Operations groups. Sarah has extensive experience with preparing regulatory submissions for biologic products for submission in the US and EU. She also has detailed knowledge on the requirements for the regulatory information systems.

Vik is responsible for the strategic and operational leadership of the HPFB IT investment plan and governance aimed to modernize and drive efficiencies within the regulatory program areas. Vik holds an Undergraduate Degree in Biochemistry & Finance from the University of Ottawa, second Undergraduate Degree in Computational Biology/Computer Science Graduate Degree in Genomics & Computer Science from McGill University.

Michiel has 15 years of experience in Regulatory Affairs and Information Management. He provides strategic direction and subject matter expertise for implementation of Regulatory Information Management (RIM) solutions. His focus goes beyond compliance, Michiel specializes in unlocking the true value of an organization’s data – whilst taking advantage of initiatives such as XEVMPD, IDMP and SPOR. Through the alignment of people, cross-functional processes, and tools, he has enabled efficient and sustainable data quality for a wide range of customers.

Stacy Tegan is a Program Director at TransCelerate Biopharma, Inc., a non-profit organization with a mission to collaborate across the biopharmaceutical R&D community. In her current role she oversees projects to enable information sharing and harmonization across the clinical development process. She has expertise in Regulatory Operations, Clinical Development processes, and Project Management gain through 20+ years of experience working for sponsor, consulting, technology, and nonprofit organizations in the pharmaceutical industry.

Peter is the Sr. Director of Publishing & Submissions for Astellas. This global group has responsibility for compiling, dispatching and archiving submissions and ensuring those activities are captured in the appropriate systems. Peter has been involved in multiple global programs targeting process improvements around product change control, document management and submission management. Prior to moving into Regulatory Operations, Peter worked in IT at Astellas focusing on informatics in the areas RA, QA and document management. Peter has a Bachelor’s degree in Mathematics from Austin College in Sherman, TX, and an MBA from the Lake Forest Graduate School of Management.

Jamie has over 18 years of IT experience in the pharmaceutical industry. She has been with BeiGene since January 2022 as the Global Head of Trial Master Management & Records. Prior to that she was with Daiichi Sankyo, Inc., for over 5 1/2 years. She is a Steering Committee member of the DIA TMF Reference Model Working Group and on the Operations Committee and a Director for the Health Sciences Records and Archives Association (HSRAA). She also serves on the AVOCA Safety Leadership Advisory Board. Jamie is a Certified Project Manager (CPM), a trained Six Sigma Green Belt, and is PROSCI certified.

JJames Riddle is the Senior Vice President of Global Review Operations at Advarra, the world’s largest provider of ethics, safety, and compliance oversight reviews services. With 25+ years’ experience providing support to the clinical research community, Riddle has operational responsibility for Advarra’s global review services including IRB, IBC, DMC, EAC. In this role, he helps sponsors, CROs, and research sites advance clinical research with a mission to improve human health. Riddle is a regular speaker at industry events and has written abundantly on research compliance and efficiency topics. He is also a member of CTTI, NWABR, SASI, and PRIM&R.

Jim is a senior professional with over 20 years combined experience in risk management, technology and cyber security for numerous organizations in various industries, emphasizing healthcare and public sectors. Given the dramatic changes in technology and healthcare delivery, Jim recently founded the Institute for Healthcare Financial Technology, which is a non-profit organization dedicated to improving the healthcare value chain to reduce costs and streamline access and delivery of healthcare. IHFT builds on the innovations of financial, insurance and healthcare technology, especially in such concepts as distributed ledgers, blockchain, Robotic Process Automation (RPA) and Artificial Intelligence (AI).

Ethan Chen provides overall leadership to CDER in streamlining electronic and traditional submissions and delivering solutions to enable rapid adoption of emerging electronic data standards. Since joining the FDA in 2012, Mr. Chen has led several critical initiatives as the CDER Informatics Architect, including Data Management, Analytics and Business Intelligence, Electronic Submission and Portal Collaboration programs. Ethan has over 20-years’ experience in Data Management, Enterprise Architecture, Solution Development and System Integration.

La Misha Fields is the Program Manager of FDA’s Electronic Submissions Gateway (ESG) under the Office of Information Management and Technology located in Rockville, MD. She is an informatics and technology professional with over 10 years of FDA experience, including 5+ years in the Center for Drugs. She currently manages all activities from initiation of new requirements, development, operations and maintenance of the Gateway.

I have been in the life sciences industry for over fifteen years functioning entirely in the Regulatory Operations space. My career began in regulatory publishing and over the past decade has gravitated towards the technology and process side of the business. I currently lead the RIM group at Mersana Therapeutics where I am responsible for the creation and evolution of the Regulatory Information Management business unit; RIM ecosystem, publishing and associated operating procedures. Prior to Mersana I have worked at several other pharmaceutical/biotech companies including Black Diamond Therapeutics, GSK/Tesaro, Shire, Sunovion, Ariad, Ironwood, Pfizer, Regeneron, Ipsen and Genzyme.

Steve Gens (MSOD) is the Managing Partner of Gens & Associates Inc., a global Life Science benchmarking and advisory firm specializing in performance improvement, strategy, industry analysis, benchmarking and organizational transition. His early career was spent at Johnson & Johnson in a variety of management positions and then transitioned to consulting where he lead global Life Science consulting practices for First Consulting Group and Booz Allen Hamilton. His organization is well known for their insightful industry benchmarks and World Class RIM thought leadership. Steve has a Bachelor’s of Science in Business Computer Science and a Master in Organizational Development and Performance.

Dr. Grandinetti is a reviewer in the Good Clinical Practice Assessment Branch of the Division of Clinical Compliance Evaluation /Office of Scientific Investigations in CDER/FDA. She provides regulatory and scientific oversight for CDER-assigned bioresearch monitoring activities and scientific and clinical oversight to FDA field investigators. She serves as a subject matter expert in GCP inspections to evaluate data integrity, quality, and safety of human subjects in clinical trials.

Kelly is a recognized industry leader in RIM and IDMP with 30 years in the pharma industry, the last 17 focused on Regulatory Affairs. She currently heads K2 Consulting, a specialty firm focused on Regulatory Affairs, has previously held leadership positions in IT and Regulatory Operations/RIM at Wyeth, Pfizer, Shire and Teva. Kelly is part of the Gens & Associates World Class RIM core reasearch team, has been actively involved in the EU implementation of IDMP as a member of the SPOR Task Force and its PMS subteam, and currently the President of IRISS Forum.

Morten is an experienced IT professional with 20 years expeirence in the field of IT for Life Sciences. Morten's experience covers more or less every value cycle within Life Sciences from Clinical, Regulatory, Quality, Manufacturing Supply Chain and Commercial. At NNIT, Morten holds the position of Consulting Director, where his primary responsibilities are Client Engagement, Strategy, Services and Partnerships. During the last four years, Morten has lead NNIT's Digital Transformation efforts for Life Sciences, to drive business, data and technology driven services towards value creation for our customers and eventually improved health outcomes for the patients they serve.

Greg is currently Associate Director Regulatory Affairs at Nabriva Therapeutics and has worked in regulatory affairs for over 16 years with CROs and small/medium size Pharma. Greg specializes in eSubmission projects including the preparation and submission of INDs/BLAs/NDAs. His responsibilities include interacting with global regulatory authorities, implementation of document management systems, and tracking life-cycle submissions.

Eileen Navarro, MD, FACP serves as lead in the Office of Computational Science which implements regulatory science (tools, standards and analytic approaches) to support a modern regulatory review process.

Matt Neal is an author and frequent keynote speaker. He joined Atara Biotherapeutics in 2019 as the Head of Regulatory Operations. Prior to that, Matt was the Head of Product Management for the InSight Suite of Regulatory Information Management Solutions at Parexel, Inc. and partnered with Microsoft. Before joining PAREXEL, Matt was a Director of Regulatory & Safety Operations at Amgen, Inc. (2003-2016) and was one of the pioneering members of the Regulatory Submissions Department for GlaxoSmithKline (1996-2003). Matt has been publishing and submitting electronic dossiers to the FDA since 1996, and submitted the very first fully electronic NDA for GSK in 1999.

Vada A. Perkins is Vice President. Global Head of Regulatory Policy & Intelligence for Boehringer Ingelheim. He is a former FDA Senior Advisor for Regulatory Science with international regulatory policy and strategy expertise in promoting convergence for the assessment of medicinal products worldwide. He received his degrees from Johns Hopkins University, University of Southern California, and the University of Maryland.

Fran Ross is Practice Director for Trial Master File Practice at Advanced Clinical, driving the implementation and expansion of our document management solutions and TMF consulting offerings. Fran oversees eTMF optimization projects, including conversions, system deployment, migrations, reporting and inspection surety. Fran has over thirty years of industry and academic trial experience including CTMS, QMS, TMF, clinical operations and risk management. Fran is an active member of TMF Reference Model Steering Committee.

Laura has 30+ years of experience in the pharmaceutical industry, working largely in Supply Chain Management and Regulatory Affairs. She’s had responsibility for the manufacturing coordination of multiple worldwide new product launches, as well as in-line supply. Most recently, she has been involved with improvements to the submission planning business process to optimize benefits for regulatory, production and marketing stakeholders. In her current role, she is focused on building performance management capabilities within the Regulatory Portfolio and Submission Management group. She holds Bachelor’s Degrees in Biology from LaSalle University and Pharmacy from the Temple University.

Adair has 20 years of experience in Regulatory Affairs and has worked for companies such as ImClone Systems and Celgene where she led the planning, review, and delivery of high-quality regulatory submission dossiers in support of the development and registration of anti-cancer compounds worldwide. At PharmaLex Adair leads a team of Regulatory Affairs professionals and is accountable for the overall planning and management of Regulatory Affairs resources to effectively support timely and quality submissions to Health Authorities (i.e., FDA, Canada, etc.). Adair is experienced in defining, assessing, and improving processes and works closely with life sciences companies to plan and manage successful Regulatory projects.

Cynthia is currently a Clinical Trials Specialist at the National Center for Advancing Translational Sciences (NCATS). She was recently on special assignment with the NIH Office of Science Policy working on the NIH-FDA Phase 2 and 3 IND/IDE Clinical Trial Protocol Template, and a related web-based e-protocol writing tool. She has experience in clinical research operations, trial management and oversight. Cynthia holds an M.S. in Biochemistry and Molecular Biology from Georgetown University.

Alex Butler is MasterControl’s manager of medical device solutions. He leads the development efforts for MasterControl Registrations. He’s also responsible for developing and/or improving other software solutions, namely MasterControl Customer Complaints, Bill of Materials (BOM), Projects, Risk Management, and PDM Connector. His medical device experience includes working as a product development manager for an orthodontic product manufacturer where he helped launch several Class II medical devices.

Nicholas Drago is Associate Director of Global Regulatory Strategy at Bayer Pharmaceuticals. Previously, he led Bayer’s global regulatory policy efforts for cell & gene therapy and spearheaded the application of data science to support decision making in regulatory affairs. Nicholas has 10 years of experience in regulatory affairs. He holds a B.S. in biology from University of Rochester and M.S. in regulatory affairs from Northeastern University.

Dalia earned a doctorate in Biomedical Science and has over 20 years of experience in the industry. Dalia’s unique background blends entrepreneurship, management consulting and industry in the pharmaceutical, medical device and healthcare industries, delivering innovative solutions in research, operations, strategy and technology. Dalia was top Strategy/Change consultant at PA Consulting & IBM & a top performer at Shire. Dalia is currently a Partner at Pyxa Solutions, her comprehensive background, has positioned her to lead Pyxa’s R&D Consulting and Technology Services.

Vahé has over 24 years of global regulatory operations, project management and regulatory technology experience, with special focus on regulatory information management, data governance, business process optimization, regulatory intelligence, medical imaging, publishing and global submissions strategy. Vahé has had various leading roles at Alexion, Takeda, Dyax, Millennium, Parexel, and Datafarm, and has also been involved in consulting activities. He is currently heading the Global Regulatory Operation at Apellis. Vahé is an active member of the DIA-RIMWG sub-team on RIM Reference Model.

Jim's passionate about solving business problems with strong teams that get that special mix of people, process, technology & data just right. He's been solving problems at Bristol Myers Squibb for 17 years and a couple years in the US Navy before that. He is the Head of IT for Regulatory, Safety and Biometrics @ BMS. All the details on jobs and degrees are on LinkedIn.

Mickel Hedemand is Special Adviser at the Danish Medicines Agency (DKMA) where he has been working for 11 years. He is managing DKMA’s electronic format requirements and procedures for receiving, technically validating, registering and archiving submissions in the medicines regulatory area. This also includes maintaining tools and processes supporting these activities. Among other things he is an active member of EMA’s Human Harmonisation Maintenance Group and has put his footprint on the technical validation criteria and the harmonised eCTD and NeeS guidances. He has an M.Sc. in Engineering and a past history as an IT consultant.

Professionally Andrea studied pharmacy in Heidelberg. After University, she started to work at Pharmalex as a contractor for Merck KGaA and then in 2003 joined Merck KGaA holding different positions within Global Regulatory Affairs (GRA) and Strategy & Business Operations within Research & Development (R&D). While working at Merck, she first did her Master of Drug Regulatory Affairs at DGRA (“Deutsche Gesellschaft für Drug Regulatory Affairs”) in Bonn and afterwards she did her doctor of science at the University of Bonn in the field "Regulatory Affairs". Since January 2018 she has taken over the role of Head of IDMP office, leading IDMP project as well as the implementation of IDMP, covering XeVMPD and other technology topics.

Darren Lacey has been serving as Chief Information Security Officer and Director of IT Compliance for Johns Hopkins University and Johns Hopkins Medicine for the past fourteen years. He has been working in the technology sector, as a developer, attorney, consultant and executive for twenty-five years. He was the first Executive Director of the Johns Hopkins University Information Security Institute, a National Security Agency Center of Academic Excellence in Information Assurance. He is a graduate of Baylor and Harvard.

Dr Peter Lassoff Pharm.D., FTOPRA, has over 30 years’ experience within global regulatory affairs and is the Senior VP, Regulatory Affairs, for Syneos Health. Peter has deep domain expertise in regulatory affairs and drug development, and has established and grown businesses in the regulatory outsourcing sector on a global basis. Peter is a Fellow of TOPRA, the professional society for regulatory affairs; is on the Board of Supervisors for the University of Southern California's regulatory affairs programme, and has won a lifetime achievement award for regulatory affairs, the Innovation in Regulatory Science Award at the USC School of Pharmacy.

As a Medidata Global Compliance and Strategy Principal, Fiona’s focus includes evaluation of GxP relevant regulatory changes coupled with the regulatory aspects of technological advancements and geo-political dynamics impacting the Life Sciences and Healthcare industries, specifically within in the clinical research domain. In this role Fiona regularly interacts with authorities on emerging patient centric technologies. Fiona is currently the Chair of the ACRO Decentralised Clinical Trials Working Party in the EU, focused on the end to end process, technology, data and regulatory frameworks for virtual clinical trials. Fiona is also a member of the EU Alliance on Artificial Intelligence. Prior to Medidata Fiona was a Director at Deloitte,

Jennifer Moore is a Manager within Amgen’s Global Regulatory and Affairs Operations, located in Thousand Oaks, California. She has been working to bring new M1 eCTD opportunities to Amgen since 2010, when she participated in a pilot project with the PhRMA group EASE (Electronic Advertising Submission Effort) to submit AdPromo pieces in eCTD format to OPDP. Jennifer is now a member of the IRISS AdPromo group, assisting with the creation of best practices and standards for M1 Submissions. She manages Amgen’s AdPromo Publishing team, which now successfully submits promotional materials for 16 marketed products via eCTD.

Leonard Sacks is an Associate Director for Clinical Methodology in the Office off Medical Policy, CDER, FDA, where he has worked on integrating IT opportunities into drug development. He has extensive experience with clinical trials, both as a clinical investigator and subsequently as a reviewer at FDA. He is a clinician, board certified in Internal Medicine and Infectious Diseases.

Kristen has 20 years of experience helping life sciences clients create modern and innovative regulatory practices and processes that leverage cutting-edge technology to satisfy both FDA requirements and their bottom line. She has built and led global regulatory operations and project management teams for top industry organizations using forward-facing strategy and business systems. Her experience includes comprehensive knowledge of electronic submissions requirements, connections into e-subs group, strong experience in pharmaceutical process and submission preparation through pre-market and NDA stages of development, and strong exposure and awareness of post-marketing and international filings.

Ms. Sinsel has a passion for Regulatory that began with her first professional career in Regulatory Affairs at Merck in 2002. She has been with Inovio for 4 years and has embraced the small company atmosphere and the challenges that come with it. Most noteworthy, she, along with her IT colleagues, moved Inovio into the "electronic submissions world’’, as well as in helping others find solutions to do the same. Combining her associate’s degree in Business Administration; paralegal, her bachelor’s degree in Organizational Management and her 15 years of experience in various Regulatory groups, Regulatory Operations is a combination of all.

Cary is the Managing Partner of LeapAhead Solutions and has over 30 years of experience in life sciences focused on leading strategic initiatives to drive increased business productivity, enhance regulatory compliance, and simplify information management and the use of technology. Her areas of expertise include regulatory information management, intelligent automation, data strategy/governance, e-submissions, R&D and GxP content management, IT strategy, enterprise architecture, Agile, business process optimization, and project/program/portfolio management. Cary co-leads the DIA RIM Working Group, leads the DIA RIM Intelligent Automation Topic Team, and regularly serves as an industry thought leader.

Karen currently serves as VP, Publishing and Product License Support for Pfizer having dedicated 20 years to the global Regulatory Operations arena. Karen is passionate about ensuring optimum quality and efficiency for high end delivery of regulatory submissions and regulatory information custodianship. Karen has led her organization with innovative leading edge strategies to generate new business opportunities and dynamic global operating models ensuring data and cost transparency. Karen earned a BA (Hons) degree in Civil Engineering from Aston University, UK and currently serves on the Board of Directors for IRISS (Implementation of Regulatory Information Submission Standards) Industry forum.

Beth joined J&J Regulatory Operations in 2015 to design & implement a new regulatory operations organization that serves the needs of the Pharmaceutical, Medical Device & Consumer businesses at J&J. Currently, her group is responsible for optimizing translations, access to Regulatory Requirements, and the optimal use of technology solutions to deliver future state Regulatory capabilities. With >30 years’ experience, 23 years at J&J, Beth has provided regulatory leadership & support for US and global teams for consumer products, medical devices, biologics, and pharmaceuticals.

Mitzi Allred is a Director at MSD where her focus is on Structured Content Management. She has over 20 years of experience in the biopharmaceutical industry in Regulatory & Clinical Operations. Mitzi uses process improvement through information design and structured content reuse to leverage time. quality and efficiency for content within documents . Over the last fifteen years, she has led improvements in electronic documents, structured content management reuse implementations. Mitzi participates in the TransCelerate Clinical Content & Reuse workstream and ICH M11 Working group. Additionally, Mitzi has PhD in engineering and 15 years of experience in Aerospace.

Thomas has 15+ years industry experience in Regulatory Affairs focusing on document management, publishing and submission of applications / authorizations. Managed electronic publishing projects for submission to competent authorities this includes submission life-cycle management and maintenance during approval and post-marketing.

Lillian is the QA/RA Director at a small life sciences organization which sells product in over 20 countries. She is fortunate to have worked and trained in various industries, from laboratory to software to medical device. In each setting, Lillian has further developed her passion for applying risk-based innovation to the sometimes-complicated field of regulatory compliance. Lillian lives and works in Salt Lake City, Utah.

Stephanie currently works for Teva Pharmaceuticals as a Regulatory Submissions Management Associate. She has more than 10 years of experience in regulatory eCTD publishing. This includes publishing NDAs, BLAs and ANDAs. Stephanie has recently lead publishing efforts in both original ANDAs and safety report management. She has also lead projects that have offshored transactional work and has helped standardized submission processes and standards. Stephanie holds a Bachelors of Science from Walden University.

25+ years with Abbott/Abbvie in both Pharmaceutical and Nutritional product development. Career has spanned multiple areas within the Information Technology group including support for Nutritionals, Medical Devices and Pharmaceuticals. Within Pharmaceutical R&D responsibilities for the International Scientific and Medical Affairs organizations which included Regulatory Affairs and affiliate support. Transitioned to business operation as the Head of Registration Planning and Operations for International Regulatory Affairs in support of drug registrations in paper and the movement to electronic submissions globally including eCTD and NeeS formats eventually expanding responsibilities as Head, Global Submission Operations.

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.

Mr. Martens has over 37 years of experience in information systems development for Life Sciences and has served for over 22 years as a Technical Expert for the JPMA on the ICH (www.ich.org) M2 and M8 Expert Working Groups. Mr. Martens has worked with clients and regulatory agencies in the EU, Japan, Canada and the US in the areas of eSubmission strategy, document and records management, tool and vendor selection, and software integration. He is the co-founder of IRISS (www.iriss-forum.org) and serves on its Steering Committee.

Ann E. McCabe Director, Process Excellence & Risk Management Ann McCabe is Director, Process Excellence & Risk Management at Daiichi Sankyo. She has worked in clinical research for over 20 years at various global pharma, biotech, medical device and consulting companies. She has worked in the areas of Clinical Operations, Quality, Process Improvement and Training. She is currently assisting Daiichi Sankyo in the implementation of Risk Based Quality Management (ICH E6 R2), study metrics and various process improvement projects. She has Bachelor’s degrees in Biology and Medical Technology from the University of Delaware.

Remco Munnik is a Director at Iperion, a Deloitte company. He has more than 20 years’ experience in Life Science and Regulatory Affairs, including more than a decade providing consultancy around Regulatory Information Management (RIM) and electronic submissions. He is a respected subject matter expert in RIM, eCTD, xEVMPD and ISO IDMP. Remco is Chair of Medicines for Europe Telematics group; and President of the IRISS Forum, a global, open, multidisciplinary, non-profit networking organisation for life science professionals by life science professionals.

Jim has nearly 30 years of experience with compliant software solutions for regulated processes in both the insurance and life sciences industries. He has held senior management positions at Intracorp (a CIGNA company), Liquent, Thomson Reuters, ePharmaSolutions, DitaExchange and Cunesoft. Following the merger of Cunesoft into Phlexglobal, Jim is now the Chief Product Officer at Phlexglobal. Phlexglobal is now part of Cencora PharmaLex. Jim holds a Bachelor of Science in Mathematics from The Pennsylvania State University.

Lawrence Rich is a founding partner of the regulatory compliance and information technology consultancy GxP Authority, Inc. and an internationally recognized expert on the regulations that govern electronic records, electronic signatures, electronic submissions, and data privacy in the life sciences industry. During his 28-year career in the life sciences industry, Lawrence has successfully delivered secure, reliable, scalable, and cost-effective information technology and regulatory compliance solutions to scores of biotechnology, medical device, and pharmaceutical companies. Lawrence has undergraduate and graduate degrees in applied mathematics, and is available on a consulting basis across North America, the European Union, and Japan.

Dr Eckart Schwarz currently is the Senior Vice President of Global Regulatory Platforms and Delivery, GSK. Eckart originally trained and worked as a physician in the UK, and then in the last 26 years has had roles of increasing seniority in GSK, right across the drug development spectrum, in areas such as Reg. Affairs, Med. Affairs, Marketing, Clinical and Quality Assurance / Compliance. He is based in the US but has lived and worked in Germany, UK, Singapore, India and Belgium.

Kevin Tompkins is the Executive Director, Regulatory Information and Submission Management at Bristol Myers Squibb. He joined BMS in 2018 and has over 20 years of experience in different roles leading regulatory operations teams. In his current role, Kevin is responsible for the strategic direction and delivery of regulatory submissions, product data, and regulatory systems for BMS. He holds a B.S. in Information Systems and a M.B.A. from LaSalle University.

Hans van Bruggen has been involved in the transition form paper to digitalized paper to data exchange to data sharing. Key areas of expertise: lean regulatory documents, data capture right-first-time, and reuse rather then recreate or copy. Hans has an MSc in Pharmaceutical Medicine from the University of Surrey and has worked within, or for, the pharmaceutical industry for more than 30 years in Global or European Headquarters. Using that scientific background he brings together people, processes and tools, leading to lean interdisciplinary and international processes.

Cesar serves as Interim EU & International Policy Lead at Accumulus Synergy within Regulatory Innovation. He engages with industry experts, national regulators, and global organizations to foster policy changes and develop strategies that enhance regulatory frameworks, promoting industry collaboration through a cloud-based data exchange model. Cesar supports efforts that permit the adoption of the Accumulus platform by both sponsors and regulators. Additionally, he leads a Topic Group Digitalization in Regulatory for IRISS, pushing forward industry-wide digital advancements. Cesar has over two decades of experience, the last 12 years he spent in Submissions Management leadership roles within Regulatory Operations at Pfizer.

David Berglund is the Global Head of Regulatory Operations in AstraZeneca/MedImmune. Oversing regulatory & document publishing, registration & submission lifecycle, and dossier management throughout all disciplines, world wide. David has held a number of positions in AstraZeneca, including Program Director for a number of change programs in the regulatory information space. Currenly based in Gaithersburg Maryland, USA, and previously worked in United Kingdom and Sweden. David holds a BSc in Computer Artificial Intelligege from the University of Uppsala, Sweden.

Valerie M Gooding has been with FDA since January 2008. Valerie has over 18 years of Regulatory experience. She is currently a Project Management Officer (Team Lead) with Office of Business Informatics. As member of CDER’s Electronic Submissions Team, Valerie advises on eCTD, validation, guidance and compliance with electronic submission policies. Valerie facilitates eCTD viewer training to CDER review community and review and assess sample eCTD submissions and Briefing Packages. Prior to joining the FDA, Valerie worked 8 years for a local Pharmaceutical Company in Rockville, where she served as Regulatory Affairs Administrator in both Clinical and Regulatory Department.

Christina Mantzioros holds a Master of Science degree in Pharmaceutical Sciences from the University of Montreal. Christina has worked for both academic and contract research organizations in the setup and management of international, complex clinical trials in different therapeutic areas. She brings important industry and clinical research experience to Montrium, facilitating the expansion and innovation of Montrium’s Electronic Content Management platform. She has recently become involved in a subgroup of the TMF Reference Model Project Team working towards the development of a standard mechanism for eTMF exchange.

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.

Dr. Mulinde is currently the Senior Policy Advisor, Division of Clinical Compliance Evaluation in the Office of Scientific Investigations, CDER, FDA. Prior to joining the Office of Scientific Investigations, she was a Clinical Team Leader in the Division of Anti-Infective Products in OND. She received her M.D. and completed a residency in Internal Medicine at the University Of South Alabama School Of Medicine, and then completed a fellowship in Infectious Diseases at the University Of Maryland School Of Medicine.