is being presented by Kathleen Mandziuk & Cathy Michael, Scientific Affairs Director & Senior Director of Comprehensive Solutions, with PRA & BioStorage Technologies and airs on Thursday, May 3rd, 2012. For more details or to register, please visit our site at www.fxconferences.com
*PRA is sponsoring this event, making it complimentary for all registered attendees. Please register for this event, and submit complete attendee information once you've registered, so we can assure you a space in the webinar. Incomplete registrations will not be honored. Please register each line for your group separately.*
Webinar highlights
The exponential increase of discovery, validation and commercialization of diagnostic and companion biomarkers has lead to a greater need for effective, efficient and proven research methods. Many industry experts focus on processing biological samples – however, what happens beforehand to ensure high-quality samples and data is collected?.
This educational webinar will focus on the evolving space of biomarker research and established techniques for cost-effective high-quality execution strategies. The speaker will cover a wide variety of topics from various industry perspectives.
Wednesday, April 25, 2012
Tuesday, April 24, 2012
What's New with Investigational Device Exemptions (IDE)?
is being presented by Cheryl Hill, Regulatory Manager, with Pleiad Inc. and airs on Wednesday, May 2nd, 2012. For more details or to register, please visit our site at www.fxconferences.com
Is the IDE program changing? Over the past 12 months FDA has released several proposed rules, final rules, draft guidances and final guidance documents. Some of these documents have an immediate impact on the IDE program, such as the final rule regarding Informed Consent Elements. This rule mandates that for all applicable device (or drug/biologic) clinical trials, informed consent documents and processes include a specific statement that the clinical trial information will be entered into a databank – with a compliance date of March 2012. Other documents, such as the draft guidance FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations, which explains all possible decision outcomes of an IDE submission, provide insight into the IDE program and Agency expectations.
This audio conference presentation provides an overview of these documents, as our speaker explains their impact on IDE regulations and offers suggestions for compliance.
Is the IDE program changing? Over the past 12 months FDA has released several proposed rules, final rules, draft guidances and final guidance documents. Some of these documents have an immediate impact on the IDE program, such as the final rule regarding Informed Consent Elements. This rule mandates that for all applicable device (or drug/biologic) clinical trials, informed consent documents and processes include a specific statement that the clinical trial information will be entered into a databank – with a compliance date of March 2012. Other documents, such as the draft guidance FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations, which explains all possible decision outcomes of an IDE submission, provide insight into the IDE program and Agency expectations.
This audio conference presentation provides an overview of these documents, as our speaker explains their impact on IDE regulations and offers suggestions for compliance.
Monday, April 23, 2012
FSMA and Traceability – Complying With FDA's New Requirements
is being presented by Pamela Sweeten, Principal, of P. Sweeten Consulting and airs on Tuesday, May 1st, 2012. For more details or to register, please visit our site at www.fxconferences.com
Under the traceability provisions of the Food Safety Modernization Act, food producers, manufacturers and distributors must be able to provide FDA with all of the data necessary data to facilitate a product recall with as little as four hours notice. So what does this mean in practical terms? How should your company go about capturing and storing all that data?
This timely audio conference presentation looks at what FDA will require from growers, packers, processors and shippers to accurately track processes, and what specific issues are likely to arise based on these new rules in a real-world context. Our speaker provides attendees with valuable insight into which changes should be of most concern, what they can expect in the coming months, and how best to prepare.
Under the traceability provisions of the Food Safety Modernization Act, food producers, manufacturers and distributors must be able to provide FDA with all of the data necessary data to facilitate a product recall with as little as four hours notice. So what does this mean in practical terms? How should your company go about capturing and storing all that data?
This timely audio conference presentation looks at what FDA will require from growers, packers, processors and shippers to accurately track processes, and what specific issues are likely to arise based on these new rules in a real-world context. Our speaker provides attendees with valuable insight into which changes should be of most concern, what they can expect in the coming months, and how best to prepare.
Friday, April 20, 2012
Managing Legal and PR Risks in Social Media
is being presented by Allison Fitzpatrick & Laura J. Protzmann, Partner & Counsel, of Davis & Gilbert LLP & The Dannon Company, Inc. and airs on Thursday, April 26th, 2012. For more details or to register, please visit our site at www.fxconferences.com
With the explosion of social media has come a significant increase in the level of regulatory scrutiny, making it imperative to put in place policies and practices compliant with applicable laws. This audio conference presentation discusses the rules that apply to social media, and what you need to do to comply with the law, including the FTC endorsement guides.
Our speakers also address the legal and PR issues that arise when marketers, their employees, bloggers, affiliates and spokespersons fail to comply with FTC endorsement guides. The presentation explains why it is so important to have a social media policy, and what should be included in that policy. Lastly, the speakers also discuss what rules apply when conducting a promotion using social media, including Facebook and Twitter.
With the explosion of social media has come a significant increase in the level of regulatory scrutiny, making it imperative to put in place policies and practices compliant with applicable laws. This audio conference presentation discusses the rules that apply to social media, and what you need to do to comply with the law, including the FTC endorsement guides.
Our speakers also address the legal and PR issues that arise when marketers, their employees, bloggers, affiliates and spokespersons fail to comply with FTC endorsement guides. The presentation explains why it is so important to have a social media policy, and what should be included in that policy. Lastly, the speakers also discuss what rules apply when conducting a promotion using social media, including Facebook and Twitter.
Thursday, April 19, 2012
The Foreign Supplier Verification Program and What It Means for the Food Industry
is being presented by Marc C. Sanchez, Regulatory Counsel, with Contract In-House Counsel and Consultants, LLC and airs on Wednesday, April 25th, 2012. For more details or to register, please visit our site at www.fxconferences.com
The Foreign Supplier Verification Program (FSVP) automatically takes effect in 2013 under the terms of the Food Safety Modernization Act. Congress had set a one-year deadline of January 4, 2012 for the FDA to publish details on how it will regulate imported foods. This includes verifying foreign suppliers, a definition of high-risk foods, and a certification process. While the FDA missed that deadline, it has promised a rule and guidelines soon.
In the meantime, the FSMA makes it clear that the foreign supplier verification program will become mandatory in 2013, whether a rule is in place or not. In this audio conference presentation, our speaker provides an overview of the FSVP, looks at the likely FDA definition of high-risk foods, and what is likely to be the certification process. The presentation also provides advice on how to cope with compliance when the FDA lags behind in rulemaking.
The Foreign Supplier Verification Program (FSVP) automatically takes effect in 2013 under the terms of the Food Safety Modernization Act. Congress had set a one-year deadline of January 4, 2012 for the FDA to publish details on how it will regulate imported foods. This includes verifying foreign suppliers, a definition of high-risk foods, and a certification process. While the FDA missed that deadline, it has promised a rule and guidelines soon.
In the meantime, the FSMA makes it clear that the foreign supplier verification program will become mandatory in 2013, whether a rule is in place or not. In this audio conference presentation, our speaker provides an overview of the FSVP, looks at the likely FDA definition of high-risk foods, and what is likely to be the certification process. The presentation also provides advice on how to cope with compliance when the FDA lags behind in rulemaking.
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