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Regulatory Affairs Professionals Society (RAPS), Del Mar, CA
29 September - 1 October
| WEDNESDAY, 29 SEPTEMBER 2010 | | 8:00 am | Registration and Continental Breakfast | | 9:00 am | eCTD Overview & FDA Requirements Antoinette Azevedo, president & CEO, e-SubmissionsSolutions.com | | 10:00 am | Refreshment Break | | 10:15 am | Quality (CMC) Content Overview - Module 2-3 Quality Overall Summary
- Module 3 Drug Substance, Drug Product, Regional Information, Appendices
- Featuring a simulative, interactive group exercise to evaluate understanding of CMC
Deanna Murden, president, ePharmaCMC, LLC | | 12:00 pm | Lunch | | 1:00 pm | Safety (Nonclinical) Overview - Module 2-4 Nonclinical Overview
- Module 2-6 Nonclinical Written and Tabulated Summaries
- Module 4 Safety Study Reports and Datasets
Antoinette Azevedo, president & CEO, e-SubmissionsSolutions.com | | 2:00 pm | Efficacy (Clinical) Content Overview - Module 2-5 Clinical Overview
- Module 2-7 Clinical Summary
- Module 5-2 Tabular Listing of Clinical Studies
- Module 5 Clinical Study Reports, Case Report Forms, Datasets
Emily Onkka, Director, Regulatory Operations and Submissions, Cadence Pharmaceuticals, Inc. | | 3:00 pm | Refreshment Break | | 3:15 pm | Efficacy (Clinical) Content Overview, continued
Module 5 Case Report Forms & Datasets Emily Onkka, director, regulatory operations and submissions, Cadence Pharmaceuticals, Inc. | | 4:15 pm | Regulated Product Submission (RPS) & eCTD Next Major Version (NMV) Jason Rock, president & CTO, GlobalSubmit, Inc.
Hans van Bruggen, MSc, senior regulatory affairs consultant and director, eCTDconsultancy BV and Director, Qdossier BV | | 5:15 pm | Review of Day 1 - Q&A and Discussion | | 5:30 pm | Adjourn |
| | THURSDAY, 30 SEPTEMBER 2010 | | 8:00 am | Continental Breakfast | | 8:30 am | Hands-on eCTD Compilation Lead Trainer: Warren Perry, director of eregulatory strategies, EXTEDO Inc.
Facilitator: Antoinette Azevedo, president & CEO, e-SubmissionsSolutions.com | | 10:00 am | Refreshment Break | | 10:15 am | Hands-on eCTD Compilation
(continued) | | 11:45 am | Lunch | | 12:45 pm | Hands-on eCTD Compilation
(continued) | | 3:00 pm | Refreshment Break | | 3:15 pm | FDA eCTD Validation Specifications: How to Assure Your eCTD is Accepted for Review Jason Rock, president & CTO, GlobalSubmit, Inc.
Antoinette Azevedo, president & CEO, e-SubmissionsSolutions.com | | 4:45 pm | Review of Day 2 - Q&A and Discussion | | 5:00 pm | Adjourn |
| | FRIDAY, 1 OCTOBER 2010 | | 7:30 am | Continental Breakfast | | 8:00 am | eCTD Requirements for Europe Hans van Bruggen, MSc, senior regulatory affairs consultant and director, eCTDconsultancy BV and Director, Qdossier BV | | 10:00 am | Refreshment Break | | 10:15 am | eCTD Requirements for Canada TPP Ted Hanebach, director, regulatory standards, i3 CanReg | | 11:15 am | eCTD Requirements for Japan Harv Martens, vice president, operations for North American & Japan, Extedo, Inc. | | 12:15 pm | Conclusion | | 12:30 pm | Adjourn |
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Organized by:
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Regulatory Affairs Professional Society |
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Invited Speakers:
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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
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Deadline for Abstracts:
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N/A
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Registration:
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| REGISTRATION FEES | Register by 8 September | Register after 8 September | | RAPS Member | $1695 | $1795 | | Nonmember* | $1880 | $1980 | | Multiple Members** | $1595 each | $1695 each | | Multiple Nonmembers* | $1780 each | $1880 each | | Government/Nonprofit Member*** | $1195 | $1295 | | Government/Nonprofit Nonmember*** | $1380 | $1580 |
* The above nonmember fees include RAPS membership for 12 months for qualified applicants. By registering you acknowledge that you have reviewed and understand the membership qualifications and accept membership with the Regulatory Affairs Professionals Society.
** Multiple registration fees require three or more participants from the same company to submit individual registration forms at the same time via fax, mail or email to the RAPS Solutions Center.
*** To be eligible for the government/non-profit rates, individuals must send the completed registration form via fax, mail or email to the RAPS Solutions Center for verification and processing.
Registration Deadline: Advance registration (online, mail, and fax) will be accepted until 22 September 2010 unless meeting capacity is reached; after 22 September 2010, please contact RAPS Solutions Center at +1 301 770 2920 ext. 200 or raps@raps.org for registration options.
Cancellation Deadline: 8 September
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E-mail:
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acallery@raps.org
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