Antoinette Azevedo, president, e-SubmissionsSolutions.com, founded the organization in an effort to advise biotechnology and pharmaceutical companies on the use of technology to manage regulatory and controlled documents and publish electronic submissions and registrations. Azevedo's clients range from large, international pharmaceutical companies to small, virtual biotechnology companies. Previously, Azevedo was director of west coast operations for Liquent and principal consultant in CSC Consulting life sciences practice. Azevedo’s experience ranges from developing strategies for document management and electronic publishing, to implementing fully-validated systems accepted by regulatory authorities worldwide.
Ted Hanebach, RAC, director, regulatory standards, CanReg Inc., is an expert in document management and electronic regulatory submissions specifically in XML and open source applications in regulatory standards, document management and data transfer. Hanebach participated in Canadian Therapeutic Products Directorate’s Electronic Standards for Transmission of Regulatory Information (TPD ESTRI) and eCTD working groups and is a member of the validation, document management and e-submissions subcommittees of the Drug Information Association’s Special Interest Area Communities and Regional Information Systems Sharing (RISS) eCTD Lifecycle group. Previous experience includes development, technological management and instruction of manufacturing processes. Hanebach was an instructor in information technology and regulatory standards in regulatory affairs at Humber College, School of Health Sciences in Toronto.
Harv Martens, vice president of operations for North America and Japan, Extedo, Inc., has over 32 years of experience in information systems development for Life Sciences and has served for over 14 years on the ICH M2 Expert Working Group. 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. In 2008 he joined Extedo, Inc. in his current position.
Deanna Murden, president, ePharmaCMC LLC, has more than 18 years of drug development and regulatory experience in the pharmaceutical industry. Murden’s experience includes global drug development strategy, regulatory chemistry, manufacturing and controls (CMC), and lead health authority liaison for major product approvals worldwide. Murden is actively engaged in regulatory policy and is an industry leader on strategic aspects of eCTD standards and practices for CMC dossier management and compliance, bringing a holistic view to the organization’s operations and management of complex CMC storage and retrieval data systems. Murden is a graduate of two executive education programs from the University of Michigan Ross School of Business.
Emily Onkka, director, Cadence Pharmaceuticals Inc, serves as the head of regulatory operations and document management, and is a frequent presenter on eCTD. Her background in the biopharmaceutical industry includes previous positions with Sirion Therapeutics, Applied Molecular Evolution (AME)/ Eli Lilly and Company and Santarus Inc, where she has grown her experience with a host of specialized software. Onkka has extensive experience in eCTD organizational implementation and project management, as well as in the preparation and maintenance of eCTD NDA and IND submissions. She has a history of building and leading highly effective teams that achieve competitive efficiency in regulatory operations and document management practices.
Hans van Bruggen, Msc, director of Qdossier, has many years of practical regulatory experience in the pharmaceutical industry. Van Bruggen led the successful submission and validation of the first eCTD for an initial Marketing Authorisation Application worldwide for a new chemical entity. He has a wealth of experience, specializing in first time right eCTD lifecycle management and has built up a solid reputation within the pharmaceutical industry and agencies.