Friday May 18, 2012 Friday May 18, 2012
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| Module 2 - Records and Information Mangement - Intellecual Property Date: Friday, April 13, 2012 |
| Module 3 - Records and Information Fundamentals for Regulatory Compliance Date: Friday, April 27, 2012 |
| Module 4 - Long Term Preservation Strategies for Essential Records Date: Friday, May 11, 2012 |
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Time: 10:00 AM ET | 7:00 AM PT | Duration: 2 hours |
Introduction
The process of obtaining patents can be an involved, expensive and specialized process although the USPTO and other governmental agencies have in recent years tried to simplify the process and promote electronic submission. Research records that are used to support patent claims must meet stringent requirements to be viable in support of patent applications and in case of litigation. They must be authenticated records that support:
On September 16, 2011, President Obama signed the Leahy-Smith America Invents Act into law. Several important changes took effect on the date of enactment, including some significant litigation-related changes and the new standard for instituting reexamination. Most other changes take effect in one year, although the changes to the definition of prior art (including the "first-to-file" provisions) and new post-grant review proceedings will not take effect for 18 months.
Areas Covered In This Webinar
Learning Objective
Webinar attendees will gain knowledge to guide them in the creation of an Intellectual Property records system that will support patent procurement and litigation actions.
Target Audience
This presentation is targeted to staff whose responsibilities concern the generation, protection and preservation of information that could be used to obtain patent protection or use in litigation to challenge competitors’ patents.
Introduction
Gathering appropriate information to support an application to market a new drug is a formidable task. There are records associated with pre-clinical tests, clinical studies, drug safety monitoring and drug manufacturing to be considered. Many organizations have designed elaborate schemes to assure that all information used to support is collected and stored in protective environments. Some of this collection could be used to demonstrate compliance to visiting inspectors. However, most information will never be looked at again and will be retained indefinitely.
In recent years the FDA and other regulatory agencies have issued advisories and guidelines concerning the relative importance of various types of records. They acknowledge that they cannot monitor everything and will focus on items that could have the largest impact on patient health and safety.
Keeping large amounts of information for long periods of time is very costly and usually inefficient
This presentation will discuss the concepts of progressive records management and focus in on strategies to assign retention schedules to all records.
Areas Covered In This Webinar
Learning Objective
Webinar attendees will be able to plan a more effective and efficient records program for their regulatory records that will result in saved time and money.
Target Audience
This presentation is targeted to staff whose responsibilities concern the generation, protection and preservation of information that could be used to support applications to market new drugs.
Introduction
There are categories of business records that must be kept as long as 100 years. From history we do know of cases where records of human transactions have been recovered after more than 2,000 years. However, these are special cases, not counting records carved in stone or clay, where the information was stored in an favorable environment that preserved the media and the ink. Our society today is more prolific and global, so preservation solutions must be economical and have to adhere to some standardization. Up until about 15 years ago, we were mostly talking about preserving paper records, but today it’s mostly all about electronic. We are all aware of the short life-cycle of electronic devises and software. After a few years, they often are unable to function properly, repair, update or communicate with others. We can only guess about what the next generation will look like. Despite this uncertainty there are practical strategies that can be applied that will assure that this information will remain authentic and retrievable in the future.
Areas Covered In This Webinar
Learning Objective
Webinar attendees will be able to devise a strategy that will assure that critical records will be available to be retrieved and utilized in the future.
Target Audience
This presentation is targeted to anyone who has responsibility to maintain and preserve records used in Pharmaceutical and Biotechnology businesses.
Dr. Charlie Sodano is an experienced, globally recognized information management professional. He began his career as a discovery research chemist at Pfizer and since 1985 has specialized in the management of electronic as well as paper based records and information. He managed Information Services departments at RJR Nabisco, Berlex Biosciences and Bayer HealthCare Pharmaceuticals and holds BS and MS and Ph.D. degrees in Chemistry. In December, 2007 he launched eOrganizedWorld a consulting firm specializing in the planning and implementation of records and information management systems.
Single Attendee: CAD $195.00
Group of 5 or less per location: CAD $400.00
Group of 6 to 10 attendees per location: CAD $750.00
Group of 11 to 20 attendees per location: CAD $1250.00
Single attendee refers to single participant at a single computer/login.
Group rates only apply to candidates who wish to have more than one attendee, but will be attending the webinar from a single computer/login. If multiple candidates wish to login at different locations, it will be considered as a separate additional registration and will require more than one webinar login information. Also note that one login information will only be valid on one computer.
Please contact us at webinar@ipacanada.com for multiple-location group rates or any other enquiries.