Meeting Description

Meeting Details

Statistics for Diagnostic Tests

In consideration of the Regulatory professional's need to assist with the presentation of meaningful data in a product submission, AMDM is now offering a course on statistics.  This course will be directed at a beginner's level of understanding.  Dr. Michael Walker of Stanford University and Dr. Marina Kondratovich of OIVD/FDA will team up to present an introductory overview of the essential statistics for a diagnostic test (sensitivity, specificity, ROC curves, PPV, NPV, etc). and a review of the general issues related to assessing diagnostic test performance (study design, verification bias, spectrum bias, etc.). 

Seats are limited to the first 25 who register!  Don't delay as we expect this to be a popular course. 

Seats are $150 and dinner is included. 

Wednesday   September 22, 2010

5:30 PM Attendee Check-in

6:00 PM Dinner

6:30 PM

Tollhouse Hotel 
Los Gatos, CA

Regulatory Focus on Personalized Medicine

In even years, AMDM hosts a meeting in which the regulatory environment surrounding one specific topic is explored in depth. Speakers from the IVD industry, FDA and other regulatory bodies discuss the various perspectives of the topic and share best practices for ensuring quality and compliance. 

The topic for 2010 will be Personalized Medicine.  Click here for the meeting brochure.

Thursday & Friday  September 23-24, 2010

Tollhouse Hotel 
Los Gatos, CA

Regulatory Affairs 101 Pre-Workshop Session

• Experienced AMDM members present an orientation meeting for personnel new to the field of Regulatory Affairs.
• Basic information is provided as foundation for full participation in OIVD Submissions Workshop the following two days.  Included are explanations of FDA's organizational structure, various submission routes, and regulatory jargon, as well as a very complete handout of on-line guidance.
• Sources for additional information are provided.
• Past attendees with up to 3 years of RA experience reported benefits from attending this pre-workshop session.
• Pace is very informal with lots of opportunity to seek clarification of questions or issues.
• Cost is TBD/ attendee (includes buffet dinner) -- Class size is limited to 40; register early.

OIVD Submissions Workshop

• Staff from FDA's Office of In Vitro Diagnostics Device Evaluation and Safety (OIVD) present a two day workshop on regulatory submissions and related compliance topics.
• Includes sessions on preparing submissions, as well as information on what FDA's reviewers are looking for in a submission.
• Many AMDM member companies utilize this course as required training for RA personnel, both as new employee orientation as well as periodic updates for experienced RA staff.
• Personnel from R&D and Quality also benefit from this workshop by gaining an awareness of submission processes and regulatory requirements.
• Cost is TBD/ attendee (includes breakfast and lunch buffets) -- Class size is limited to 100 and seats go quickly; register early. 

Pre-IDE / Pre-Submission Workshop

• OIVD staff and AMDM industry representatives outline the Pre-IDE process and describe the various Pre-Submission activities.
• Information, including statistical considerations, is presented on the alignment of pre-submission activities within the design and development process. 
• Attendees will gain an understanding of the purpose of a Pre-IDE meeting and the possible outcomes.
• Documentation content and format suggestions will be provided.
• FDA discussion on the development of future guidance documents.
• Cost is TBD/ attendee (includes dinner buffet).   

AMDM Annual Meeting

• Some of the world's leading authorities will be invited to speak on issues unique to the IVD industry.
• Discussions include IVD examples with appropriate resolutions.
• A variety of topics are presented related to current issues affecting the IVD industry.  These include discussions on compliance, quality systems, new guidance documents, evolving trends, legislative and regulatory actions, and international regulatory requirements.
• While anyone involved in the IVD industry is encouraged to attend, these meetings are most appreciated by the busy professional in a management position that needs to remain current and connected to the dynamic changes of the IVD industry.
• Costs:  TBD AMDM Members (Review "AMDM Members" for your company's name); TBD Non-members ("Join AMDM" now -- Member's rate is available to those paying Membership dues prior to the meeting.) 

 Updated August 24, 2010