Regulatory Submissions, Information, and Document Management Forum
Venkatraman Balasubramanian, PhD, MBA
- President and CEO
- Cabeus, Inc., United States
V. “Bala” Balasubramanian is the President and CEO of Cabeus, a niche firm providing information management products, solutions and services for Life Sciences. With over 3 decades of IT experience, Bala is a thought leader and presenter on Regulatory Intelligence, RIM, IDMP, regulatory analytics, enterprise architecture and process design. At Cabeus he is responsible for strategy, leadership and vision for a cloud platform called ReALM™ to transform the regulatory value chain for Life Sciences. Prior to Cabeus, Bala developed IT strategies and capabilities for companies such as Bristol-Myers Squibb, Roche, Aventis, Merrill Lynch, AT&T, Bell Atlantic and IBM. Bala has his PhD and MBA from Rutgers University, MS in Computer Science from NJIT
Brooke Casselberry, MS, RAC
- Cyan Life Sciences, United States
Brooke is the owner and lead consultant for Cyan Life Sciences, an active member of the Government Blockchain Association, lead member of the Global Women's Blockchain organization, and chair for the DIA RSIDM RIM Technology and Business tracks. Brooke has been consulting and developing teams in Life Sciences Operations for more than 15 years and continues to focus on client success and innovation through the application of technology.
Michelle L. Charles, MPH
- Director, Regulatory Affairs, Gene Therapy Program and Orphan Disease Center
- University of Pennsylvania, Perelman School of Medicine, United States
Michelle Charles has a Masters of Public Health from Johns Hopkins University and has been working in Regulatory since 2001. In her current role at the University of Pennsylvania, Perelman School of Medicine in the Gene Therapy Program (GTP), she works as a Director of Regulatory Affairs. Michelle spent the first 14 years of her career working in multiple regulatory roles at Merck & Co., Inc. and then moved to PAREXEL International as a Regulatory Consultant.
- Director, Regulatory Affairs Operations and Quality Management
- Merck & Co., Inc., United States
Cindy Chiu is Director in Global Regulatory Affairs and Clinical Safety group at Merck & Co. She has 18 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 Regulatory Content Authoring Management Lead. Prior to Merck, she worked as a management consultant, where she assisted clients with transitioning to and adopting new processes as a result of merger activity or technology integrations.
- Chief Technology Officer
- Genpact Pharmalink, United States
Jake Doran is the Chief Technology Officer at Genpact Pharmalink. In this role, Jake is responsible for establishing the strategic direction and defining the digital solutions across Regulatory Affairs. Prior to joining Genpact, Jake was with List Innovations LLC where he was Founder and Managing Director. List Innovations is a specialized technology development and consulting company providing Regulatory and IT solutions to the Pharmaceutical industry. Earlier in his career, Jake held positions of increasing responsibility at Janssen Pharmaceuticals and Schering Plough. Jake has a Bachelor’s Degree from Fairleigh Dickinson University where his area of specialization was Biological Sciences.
- President and CEO
- LMK Clinical Research Consulting, United States
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 D. Fitzmartin, DIAFellow, PhD, MBA
- Senior Advisor, Office of Strategic Programs, CDER
- FDA, United States
Ron Fitzmartin is Senior Advisor in the Office of Strategic Programs in CDER. In this role Ron provides regulatory guidance and technical support regarding electronic submissions and standardized study data to industry and reviewers. Recent areas of focus have included: Standardized Study Data Guidance, Study Data Technical Conformance Guide, therapeutic area standards, electronic source data capture, and electronic submissions. In addition, Ron chairs CDER’s Operations Committee on Data Standards and the PDUFA FDA-Industry Informatics Committee. Ron received a PhD in statistics from the University of Maryland, a MBA from the University of New Haven, and a MS and BS from Southern Connecticut State University.
Mark A. Gray
- Senior Project Manager, BSS, CBER
- FDA, United States
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 20 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; and Director, Division of Data Management Services & Solutions managing CDER’s electronic submission program. Mark’s current responsibilities include representing CBER in the development of international electronic submission standards, with a focus on the ICH electronic Common Technical Document (eCTD).
- Data Standards Program Manager, OD, BSS, CBER
- FDA, United States
Ginny Hussong is CBER’s Program Manager for Data Standards and has been with FDA for 14 years. She is currently creating a new data standards and electronic submissions staff within the Center, focusing on data standards strategy, implementation and related policy within CBER. As Chair of CBER’s Data Standards Committee, Ginny provides regulatory guidance and technical support regarding electronic submissions and standardized study data to industry and reviewers. Recent projects include creating a new joint data standards strategy and action plan with CDER, modernizing CBER’s study data validation process and evaluation of the SEND standard for CBER.
Joanne S. Malia, MS, MSc
- Associate Director, Clinical Documentation Management
- Regeneron Pharmaceuticals, United States
Joanne Malia is Associate Director, Clinical Documentation Management at Regeneron Pharmaceuticals. She has worked in clinical research at various global biotech, device, CRO and big pharma companies in the areas of quality management, trial master file and computer system validation for over 25 years. She is a frequent presenter and workshop leader. She has a Bachelor’s degree in Biology and Master degrees in both Microbiology and Management.
Thomas J. Noto
- Senior Director, Regulatory Operations
- Lexicon Pharmaceuticals, United States
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.
Daniel F. Orfe, MS
- President and CEO
- Regulatory eSubmissions, LLC, United States
Dan has 20+ years of experience in Regulatory Operations and Submission publishing. Dan’s a subject matter expert in "cloud-based" eCTD and EDMS solutions providing consultation via Regulatory eSubmissions, LLC. At Radius he had responsibility for activities associated with production/delivery of regulatory filings & EDMS processes/tools. At Teva he oversaw an initiative to harmonize submission publishing and document management. At Datafarm he had responsibility for global Submission and Publishing Services. At Merck, Dan established and managed electronic submission production group. Speaker/session chair at 11 DIA Annual meetings, DIA EDM Conference Co-chair from 2009 through 2011 and DIA RSIDM Conference program committee member.
Sarah Powell, RAC
- Powell Regulatory Services, United States
Ms. Powell is the President of Powell Regulatory Services. Sarah has over 30 years of experience in pharmaceutical and related regulated industries (Clinical, Quality Control, Regulatory Affairs and Regulatory Operations). In the past 16 years as a consultant, she has assisted clients with projects related to regulatory process improvements, standards development, defining filing strategies and writing and review of submission content. She has extensive experience with projects related to design and implementation of regulatory solutions (requirements definition through validation) including document management, submission planning, publishing, and registration management.
- Associate Director, Business Informatics Division, HPFB
- Health Canada, Canada
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.
- Regulatory Information Scientist
- eCTDconsultancy B.V., Netherlands
Michiel Stam works as a Regulatory Information Scientist at eCTDconsultancy and is a specialist in regulatory information management and electronic submissions. He has worked on many different projects for Pharma and Biotech companies in the past 10 years. He is currently or has most recently been involved in projects for IDMP, Registration Tracking, Structured Authoring and Track & Trace.
Stacy J. Tegan
- Manager, Regulatory Technology Consulting
- Accenture Accelerated R&D Services, United States
Stacy Tegan is a Manager of Regulatory Technology Consulting in Accenture Accelerated R&D Services with over 20 years of experience in the Pharmaceutical industry. Stacy’s foundation is in Regulatory Operations, where she successfully managed sponsor and outsourced publishing teams. Moving into consulting, projects include regulatory and clinical development process harmonization and data/document migrations. Stacy has successfully managed projects in business process optimization, standards development, and technology integration. She is experienced in end-to-end global regulatory processes from authoring best practices through to application delivery and maintenance.
Peter Terbeek, MBA
- Senior Director, Publishing and Submission
- Astellas, United States
Peter is the Senior 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 master data 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 Marie Toth, MS
- Director/Head of TMF Operations
- Daiichi Sankyo, Inc., United States
Ms. Toth has over 18 years of IT experience in the pharmaceutical industry. She has been with Daiichi Sankyo since 2016 as the Director/Head of TMF Operations; prior to that she worked at Covance for 8 years within the Trial Master File space. Ms. Toth is a Steering Committee member for the DIA TMF Reference Model Working Group and on the Board for the Scientific Archivist Group (SAG) as well as a Director on the Health Sciences Records and Archives Association. Ms. Toth is a CPM, a trained Six Sigma Green Belt, and is PROSCI certified. She received her Master’s Degree in Clinical Research & Organizational Management from Drexel University, a Bachelor of Arts in Business and Technology from Fairleigh Dickinson University.
James Riddle, MS
- Vice President of Client Services
- Kinetiq, a Division of Quorum IRB, United States
James Riddle is the VP of Client Services for Kinetiq, a consulting and technology division of Quorum Review IRB, where he employs his extensive experience managing large operations and technology teams in the human subject protection field to grow Kinetiq worldwide. Mr. Riddle is also a faculty member, mentor, and regular speaker for Public Responsibility in Medicine and Research (PRIM&R); a member of the CTTI Steering Committee; and leader of the ACRES SASI technology domain accreditation team. Mr. Riddle has a degree in accounting with an emphasis in computer science from Western Washington University, College of Business and Economics.
Jim St. Clair
- Institute for Healthcare Financial Technology, United States
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, MBA
- Director, Division of Data Management Services and Solutions, OBI, OSP, CDER
- FDA, United States
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, Chen has led the several initiatives including the establishment of the CDER Integrated Data Management program. Prior to his current role, Ethan was the CDER Informatics Architect and led the Data Management and Business Intelligence Capability team to provide critical technical capabilities to support the CDER Informatics Platform. Chen has over 20 years experience in Data Management, Data Standards, Data Governance, Enterprise Architecture, Solution Development and System Integration.
La Misha Fields
- IT Program Manager, Electronic Submissions Gateway, OIMT, OC
- FDA, United States
La Misha Fields is the Program Manager of the 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 6 years of FDA experience, including 5+ years in the Center for Drugs. Ms. Fields completed her bachelor’s degree in Computer Networking and her master’s degree in Business Administration at Strayer University.
Richard F Fredericks, MBA
- Associate Director, Regulatory Systems and Information Management
- Tesaro, United States
I have been in the life sciences industry for 10 years operating entirely within the Regulatory Operations space. My career began as a publisher and over the past decade has been gravitating towards the technology and process side of things. Currently I run the Regulatory Systems and Information Management group at Tesaro where I am responsible for managing the systems and processes within the Global Regulatory department. Before Tesaro I was at Shire where I held a similar role by providing technical knowledge & support to the Global Regulatory Affairs and Operations teams. Prior to Shire I have worked at several other pharmaceutical/biotech companies including Sunovion, Ariad, Ironwood, Pfizer, Regeneron, Ipsen and Genzyme.
Steve Gens, MS
- Managing Partner
- Gens and Associates Inc., United States
Steve Gens (MSOD) is the Managing Partner of Gens and Associates Inc., a global Life Science consulting firm specializing in strategy development, RIM, industry benchmarking and organizational performance. His early career was spent at Johnson and Johnson in a variety of management positions and then moved into consulting to lead several global healthcare 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 was recently named to the PharmaVoice 100 for 2017.
Cheryl A. Grandinetti, PharmD
- Health Scientist, Policy Analyst, OC, CDER
- FDA, United States
Cheryl Grandinetti joined the FDA Office of Medical Policy within CDER in September 2010. She is the Technical Lead on a number of FDA Guidances related to the conduct of clinical trials with a focus on the integration of electronic systems in clinical trials. She received her Bachelor of Science degree in Pharmacy from West Virginia University in 1988 and her Doctor of Pharmacy degree from Virginia Commonwealth University in 2000. Prior to the FDA, she was a Senior Clinical Research Pharmacist for the Cancer Therapy Evaluation Program at the National Cancer Institute. At CTEP, she managed several investigational agents in support of NCI-sponsored cancer treatment trials as well as a variety of activities related to new drug development.
- K2 Consulting, United States
Kelly is a recognized industry leader in RIM and IDMP with over 20 years in the pharma industry. She has led implementation of large-scale global systems and processes and is passionate about the possibilities for pharma companies to improve productivity and compliance through process-focused management of critical data. Over the past 3 years she has been a key industry leader on the EU implementation of IDMP as a member of the SPOR Task Force. Kelly has held leadership positions in Regulatory Operations and RIM at Wyeth, Pfizer, Shire and Teva.
- Vice President, Advisory
- Kinapse, United States
Michael is the Vice President of US Advisory Services for Kinapse. He has an exceptional combination of life sciences industry and consulting experience. He is focused on offering a wide array of industry-tailored services designed to improve business performance and processes in the areas of clinical operations, manufacturing, regulatory, quality, and supply chain. He has developed both strategic and tactical programs to help organizations define and implement desired changes to their operations environment. He has worked with many of the Top 20 Pharmaceutical, Biotech and Medical Device to achieve transformational change through operations improvement.
Morten Lindaa, MSc
- Consulting Director, Life Sciences
- NNIT, Denmark
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 John May
- Assistant Director, Regulatory Affairs
- Nabriva Therapeutics, United States
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 E. Navarro Almario, MD, MS, FACP
- Lead Medical Officer, OCS, OTS, CDER
- FDA, United States
Eileen Navarro is the Associate Director for Medical Affairs in the Office of Computational Science. She served in various capacities in OND for 16 years before moving to her current position. She holds a master in Translational Science, is board certified in Infectious Disease and is a founding member of the Meta-Analysis Interagency Group based at the NHLBI, NIH.
Matt Neal, MA
- Senior Director, Product Management, Regulatory and Clinical Solutions
- PAREXEL, United States
Matt Neal joined PAREXEL in 2016 as the Senior Director of Product Management for Regulatory Solutions. Before joining, Matt was a Director of Regulatory & Safety Operations at Amgen, Inc. and prior to that he was one of the pioneering members of the Regulatory Submissions Department for GlaxoSmithKline and has been publishing and submitting electronic dossiers to the FDA since 1996, and submitted the very first fully electronic NDA for GSK in 1999. Matt holds a Master’s Degree in Communication from Temple University.
Vada Perkins, BSN, MS, MSc, RN
- Regulatory Policy and Intelligence
- Bayer Pharmaceuticals, United States
Vada A. Perkins is a recognized international expert for data standards and global data management within the regulatory domain. During his tenure at U.S. FDA and in Industry, he worked closely with senior executives on a broad range of regulatory issues in development, interpretation, and implementation of guidance, regulations, and international data standards to support the comprehensive review of drugs, biologics, and devices throughout the product lifecycle.
Cheryl A. Ressland
- Executve Director, Regulatory Operations
- Daiichi Sankyo, United States
Cheryl A. Ressland, RHIA, has spent 18 years in the pharmaceutical industry as a Regulatory leader, supporting such functions as Strategic Planning, Records Management, Clinical Operations, Information Technology, Regulatory Information Management, Safety, and PROSCI. Ressland has led teams spanning multiple organizational units and has been responsible for creating global standards for information exchange within the Drug Development cross-functional organization. She is also an active member of the Leadership Team for the Community of Hope Non-Profit Organization. Cheryl is best known for her critical thinking skills and focus on successful collaboration across many internal/external stakeholders in all regions.
- Associate Director, Clinical and Regulatory Optimization
- Paragon Solutions, United States
- Associate Director, Submission Services, GDM
- Bristol-Myers Squibb Company, United States
Sharon has been with Bristol-Myers Squibb for over 26 years. She has worked in many different roles over the years. She has been in Regulatory Operations for 18 years. She is currently the Associate Director of the Submission Publishers and Publishing Planning for US and EU. She is also on the Outsourcing team for Dossier Publishing where she has worked for 5 years developing procedures and relationships with BMS' vendors to work efficiently and effectively. She most recently converted dossier publishing from a project based process to a central publishing process.
Laura Shelley, RPh, PMP
- Regulatory Portfolio and Submission Management, GRACS
- Merck & Co., United States
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 Turner, MSc, RAC
- Principal Consultant, Director Regulatory Operations
- PharmaLex GmbH, Germany
Adair has 15 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 Operations professionals and is accountable for the overall planning and management of Regulatory Operations 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.
- Clinical Trials Specialist
- NIH, United States
Alex Butler, MBA
- Product Marketing Manager
- MasterControl, United States
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, RAC
- Assistant Director, Regulatory Policy & Intelligence
- Bayer Pharmaceuticals , United States
Nick Drago is Assistant Director of Regulatory Policy & Intelligence at Bayer Pharmaceuticals. In this role, he is actively involved in several innovative technology projects in Regulatory Affairs. He has over 5 years experience in Regulatory Affairs and has worked in the US and Switzerland. Nick holds a degree in biology from the University of Rochester.
Dalia El-Sherif, DrSc, PhD
- Pyxa Solutions, United States
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.
Vahe Ghahraman, PhD
- Sr. Director
- Alexion Pharma, United States
Vahé has over 17 years of global regulatory operations, project management and regulatory technology experience, with special focus on regulatory information management, publishing and global submissions strategy. Vahé has had various roles at Takeda, Dyax, Millennium, Parexel and Datafarm, and has also been involved in consulting activities. He is currently heading the Global Regulatory Operation at Alexion.
James Hanly, MBA
- Head of IT, Regulatory, Safety and Biometrics
- Bristol Myers Squibb, United States
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, MSc
- Special Advisor, Medicines Licensing, Workflow
- Danish Medicines Agency, Denmark
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.
- Director, Regulatory Submissions Operations
- Cardinal Health Regulatory Sciences, United States
Laurie Henricks has more than 30 years of experience in the pharmaceutical industry, focusing in the areas of regulatory submissions, publishing and operations. Laurie is currently responsible for the Submissions Operations services at Cardinal Health Regulatory Sciences, supporting all types of global submissions for virtual to large pharmaceutical and biotech companies. Laurie has extensive experience in submission planning, implementation of dossier standards; training on electronic submissions, and advanced knowledge of IND, NDA/BLA/MAA/NDS, CTD/eCTD, and Clinical Study Report structure, content, and assembly including electronic and paper submissions.
Andrea Herrmann, PhD
- Head of IDMP Office
- Merck KGaA, Germany
Andrea started work at Pharmalex as a contractor for Merck KGaA and then in 2003 joined Merck KGaA holding different positions within GRA and Strategy & Business Operations within R&D. While working at Merck, she first did her Master of Drug Regulatory Affairs at DGRA and doctor of science at the University of Bonn. She has experience in registration of chemical and biological products worldwide. As a marketed product leader she was the strategic pillar for all regulatory activities for fertility products worldwide. Since April 2016 she works within Strategy and Business Operations in R&D leading the IDMP project and other cross-functional initiatives as Strategic Implementation Leader.
- Chief Information Security Officer
- Johns Hopkins University, United States
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.
Peter Lassoff, PharmD
- Vice President and Head, Global Regulatory Affairs
- IQVIA, United Kingdom
Peter Lassoff is Vice President and Head of Global Regulatory Affairs at IQVIA. In his role, he works with global clients in the pharmaceutical, medical device, cosmetic, nutrition and other industries on regulatory strategy and implementation to ensure their products are placed on the market in the fastest, least expensive manner. Dr. Lassoff has deep expertise in the development and worldwide registration of medicinal products, biotech products, ‘borderline’ products, medical devices, cosmetics and ‘cosmeceuticals’, nutritional supplements and other regulated healthcare products.
Fiona Maini, MS
- Deloitte LLP, United Kingdom
Fiona is a Director within the Deloitte Healthcare and Life Sciences Practice, she has 22 years experience working with in the Healthcare, Life Sciences and Chemicals industry crossing both public and private sector. Fiona has worked within a regulator and pharmaceutical environment implementing business, technology and organisational transformation programmes. Fiona leads Deloitte’s Global Centre for Regulatory Excellence initiative for Life Sciences supporting clients with regulatory change programmes and an account director for the provision of services to the EU regulator. Fiona has a MSc in Chemistry and a BSc in Chemistry and Management Science.
- Manager, GRAAS Ops Publishing
- Amgen, Inc., United States
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, MD
- Associate Director for Clinical Methodology, Office of Medical Policy, CDER
- FDA, United States
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 Sauter, MBA
- Director, R&D Consulting and Regulatory Practice Lead
- Paragon Solutions, United States
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.
- Manager, Regulatory Operations and Submissions
- Inovio Pharmaceuticals, Inc., United States
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 Smithson, MBA
- Principal Consultant
- OpenText Corporation, United States
Cary Smithson is a Principal Consultant in the OpenText Life Sciences Professional Services practice and has over 20 years of experience helping life science and healthcare firms drive greater productivity, streamline information management and enhance regulatory compliance. Her areas of expertise include regulated content and information management, regulatory information management, GxP quality / compliance, IT strategy and project / program management. Cary led the development of the DIA GMP Quality Systems Reference Model and participates on the EDM and RIM model teams.
- Vice President, Publishing & Product License Support
- Pfizer, Inc, United States
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.
Elizabeth M Turek
- Head, Knowledge Management
- Johnson & Johnson, United States
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, PhD
- Director, Clinical Trial Operations
- Merck & Co., United States
Mitzi Allred has over 20 years of experience in the biopharmaceutical industry in Regulatory and Clinical Operations. Mitzi focus has been on process improvement through information design and structured reuse. Over the last fifteen years, she has lead submission improvements for electronic documents, structured content management reuse implementations for labeling, CMC and Clinical Operations. As a member company participant, Mitzi has participated in the TransCelerate Common Protocol development work stream. Additionally, Mitzi has PhD in electrical engineering and has 15 years of experience in Aerospace.
Thomas Christensen, RAC
- Senior Regulatory Affairs Manager
- SynteractHCR, United States
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.
- QA/RA Director, Gas Sensing, Analysis & Delivery
- Maxtec, United States
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 J Hughes
- Regulatory Submissions Management Associate
- Teva Pharmaceuticals Inc., United States
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.
John Kiser, MSc
- Kiser Regulatory Services, United States
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.
Sandra A. Krogulski, MA
- Regulatory Operations Submission Manager
- Accenture, United States
Sandy is a Submission Manager in Accenture’s Global Regulatory Operations team. In this role, she supports clients through life cycle maintenance through training, overseeing actual submissions and consulting. Sandy oversees the management of numerous regulatory submissions ensuring projects follow global regulatory requirements and meeting submission timelines. Sandy supports a variety of submission types including CMC supplements, labeling supplements, Advertising/Promotional Labeling submissions and other amendments. Sandra has also supported original applications and regions including Canada, EMA and other rest of world dossiers. She has spoken at DIA RSIDM, and is published on Promotional, Labeling and Advertising submissions.
Harv W Martens
- Technical Expert for JPMA on ICH M2 and M8 Expert Working Groups
- United States
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.
- Director, Process Excellence & Risk Management
- Daiichi Sankyo Inc, United States
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 Quality Risk Management (ICH E6 R2). She has Bachelor’s degrees in Biology and Medical Technology from the University of Delaware.
- Regulatory Information Director
- Asphalion S.L., Spain
Remco has a Bachelor degree in a study of Management, Economics & Law. He has over fifteen years’ experience in submission procedures (CP, MRP/DCP), electronic submission and regulatory data management. Since 2011 Remco works for Asphalion, an international Regulatory Affairs consultancy, based in Barcelona and Munich. Within Asphalion, Remco is responsible for global eSubmission projects (eCTD, NeeS, RIM, XEVMPD). He is involved in CP´s, MRP/DCP, maintenance, xEVMPD, FDA submissions, xEVMPD and ISO IDMP. In addition he is the chairman of EGA working group of eCTD, on behalf of Combino Pharm. He has been involved in the implementation of: eCTD roadmap, validation criteria, eAF, CESP, EMA Gateway, xEVMPD and ISO IDMP.
- Cunesoft Inc., United States
Jim has nearly 20 years’ experience with compliant software solutions for regulated processes in Life Sciences. He's held senior management positions at Liquent, Thomson Reuters, ePharmaSolutions and DitaExchange and holds a Bachelor of Science in Mathematics from The Pennsylvania State University.
- Gxp Authority, United States
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.
Eckart W. Schwarz, MD
- Senior Vice President, Global Regulatory Platforms & Delivery
- GlaxoSmithKline, United States
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.
- Sr. Associate, Global Regulatory Affairs
- Johnson & Johnson Group of Consumer Companies, United States
Kevin Tompkins, MBA, MS
- Director, Head of North America, Global Submissions Management
- Teva Pharmaceuticals, Inc, United States
Kevin Tompkins is a Director in the Regulatory Submissions Management group at Teva Pharmaceuticals. He joined Teva in October of 2011. Kevin began his career in submission publishing and product consulting at Octagon Research Solutions before moving to Cephalon Biopharmaceuticals to lead their transition to eCTD. He currently manages the North America Submissions Management team at Teva. Kevin has over 15 years of regulatory submission and information management experience. He has implemented systems, technologies, and processes that built efficiencies in regulatory submissions management for a number of pharmaceutical companies. He holds a B.S. in Information Systems and a M.B.A. from LaSalle University.
Hans van Bruggen, MSc
- Regulatory Affairs Scientist
- eCTDconsultancy B.V., Netherlands
Hans worked for over 30 yr in Global or EU pharmaceutical industry. He held various scientific positions in Nonclinical Development and Regulatory Affairs. Since 1999 he has been involved in datamodeling for electronic maintenance, storage and exchange of regulatory information. Hans approaches business processes from an adequate benefit-risk evaluation of drugs for the patients. Therefore, he breaks down silos, applies innovative and intuitive solutions and works towards single data sources.
- Director, Head of U.S. & Canada Submissions Management, Regulatory Operations
- Pfizer, Inc., United States
Cesar joined Pfizer Regulatory Operations in 2011 leading the US submissions team, in 2013 Cesar was appointed as Submissions Management Head of Dossier Excellence, further expanding his responsibility the following in 2014 by representing Submissions Management as overall NDA/MAA/IRD Business Process Owner across Regulatory Strategy. In 2017, Cesar was appointed as Head of U.S & Canada Submissions Management team. Prior to Pfizer, Cesar began his career in 2000 with Liquent (Paraxel) forming part of a team whom delivered publishing services to a key client out of Northern New Jersey, in 2002 Cesar joined Novartis’ Regulatory Operations team in submissions before moving to Bayer Healthcare in 2007.
David W. Berglund
- Global Head Regulatory Operations
- AstraZeneca, United Kingdom
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.
- Regulatory Information Specialist, OBI, OSP, CDER
- FDA, United States
Valerie M Gooding has been with FDA since January 2008. Valerie has over 17 years of Regulatory experience. She is currently a Regulatory Information Specialist 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 , MS
- Clinical Solutions Specialist
- Montrium, Inc., Canada
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.
- Project Management Officer, OBI, OSP, CDER
- FDA, United States
Jonathan Resnick has been with FDA since January 2011. He is currently a Project Management Officer with Office of Business Informatics where he advises on eCTD and guidance as member of CDER’s Electronic Submissions Team. Mr. Resnick has been involved in a number of projects within CDER, working with stakeholders to identify and fulfill business objectives. Prior to joining FDA, Mr. Resnick spent 18 years working in IT project management supporting federal and private sector clients.
Jean M. Mulinde, MD
- Senior Policy Advisor, Office of Scientific Investigations, OC, CDER
- FDA, United States
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.
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