Developing Effective Quality Agreements: Legal and Regulatory Issues

ia being presented by Alan Minsk, Partner, with Arnall Golden Gregory LLP and airs on Wednesday, December 14th, 2011. For more details, or to register please visit our site at www.fxconferences.com

Supplier control has become a major focus area for FDA in recent years, and as such, an area which is seeing heightened enforcement efforts. This represents a significant challenge for medical device and pharmaceutical companies, who need to respond accordingly to ensure their supplier quality agreements will pass muster with FDA. The landscape is changing quickly, and those without the critical regulatory information will be ill-prepared for FDA scrutiny.

In this audio conference presentation, Alan G. Minsk, Partner and Chair of the Food and Drug Practice Team at Arnall Golden Gregory LLP, guides attendees through the critical points and the pitfalls to avoid when drafting quality agreements. The presentation addresses the vital legal and regulatory issues affecting pharmaceutical and medical device manufacturers, leaving attendees better prepared to meet customer and FDA expectations regarding supplier quality.

Jagged Little Pill: Are Innovators Liable for Generic Drug Manufacturers' Failure to Warn?

is being presented by Kelly Savage Day & Mike Healy, Senior Associate & Partner, with Sedgwick LLP an airs on Tuesday, August 30th, 2011. For more details or to register, please visit our site at www.fxconferences.com

The Supreme Court recently held that federal labeling laws preempt state failure-to-warn claims brought against manufacturers of generic drugs. While the 5-4 decision marks a significant win for generic companies, many innovators are concerned that the Court’s ruling may adversely affect their business by making it more likely that other courts will adopt the holding set forth in California’s Conte v. Wyeth decision. Under Conte, brand-name manufacturers may be liable for injuries suffered by those plaintiffs who take a generic version of their brand-name drug.

This audio conference examines the potential legal risks innovators face, and offers concrete suggestions for proactively mitigating these risks. The presentation focuses on the current status of the law concerning innovator-generic liability, featuring speakers with first-hand experience in this litigation and the industry-shaking issues it raises.

Negotiating Clinical Study Agreements With Academic Medical Institutions

is being presented by Karen A. Mullin, JD, LLM and airs on Wednesday, July 20th, 2011. For more details, or to register please visit our site at www.fxconferences.com

The process of negotiating a clinical study agreement between a bio/pharmaceutical company and an academic medical institution can be difficult, in part due to the sometimes divergent goals of the two parties. This audio conference presentation reviews the expectations of both the bio/pharmaceutical company and the academic medical institution when negotiating clinical study agreements. Our speaker addresses in depth the key issues of confidentiality, publication, intellectual property rights and indemnification. The presentation also includes discussion of appropriate language to enable the parties to fulfill their different objectives and legal obligations. Finally, our speaker shares tips and insight on ways to speed up the negotiating process.

Patent Portfolio Strategies in the Post-KSR Environment

Essential information for legal counsel and product development teams!

The Supreme Court’s decision in KSR v. Teleflex profoundly changed the landscape for biopharma companies and medical device manufacturers when it comes to building patent portfolios and managing them. More recently, the Federal Circuit’s Bilski decision in October 2008 added yet another dimension of complexity.

In this audio conference, we examine how this new environment changes the work of managers and professionals in product development teams, as well as patent professionals seeking to protect innovations. The presentation looks at how to identify and strengthen patents that might be vulnerable to obviousness attacks, and discusses ways to write and prosecute them to mitigate that risk.

Patent Portfolio Strategies in the Post-KSR Environment was presented by Bruce D. Sunstein, Co-Founder & Partner, Bromberg & Sunstein LLP and aired on 2009-02-12. For more details or to download this event, please visit our site at www.fxconferences.com

Complying with EU Antitrust Laws

It is vital that any company doing business in Europe be aware of existing antitrust provisions, and perhaps especially important for those in the life sciences. This presentation gives a general overview of EU antitrust law, and highlights those areas of particular relevance to medical device and pharmaceutical companies. The presentation places added emphasis on identifying special areas of risk, such as agreements restricting competition, information sharing between competitors, distribution agreements and abuse of market-dominating positions. Our speakers will also discuss when you should seek legal assistance, and how to behave in the event of dawn raids.

Complying with EU Antitrust Laws is being presented by Marc Besen & Dr. Christian Mayer, Partner & Associate, Clifford Chance and airs on Tuesday, March 10th, 2009. For more details or to register for this event, please visit our site www.fxconferences.com

Global Patent Standards

Is your patent adequately protected in all of the markets where you do business? Are you sure about that?

In many industries, patent protection in both the United States and abroad is critical, but the requirements for each country are not necessarily the same. Thus, in developing a patent strategy, the different requirements of countries where protection is desired must be considered prior to filing.

In this audio conference, we review the various global patent standards in countries where patent protection is typically sought. Particular emphasis will be placed on written description requirements, obviousness and inventive step standards in the United States and in Europe.

Global Patent Standards is being presented by Christopher Rhodes, PhD, JD, Intellectual Property Attorney, with Lowrie Lando & Anastasi LLP and airs on Thursday, January 15, 2009. For more details or to register for this event, please visit our site www.fxconferences.com

Bulletproofing Personnel Policies Against Litigation

Are you concerned that your HR policies and processes might be leaving you vulnerable to lawsuits? No one sets out to create policy risks and personnel litigation. Yet every year a new crop of employee lawsuits are spawned by claims of inattention, inconsistency or unfairness in applying organization policies.

Learn how to avoid the costly loopholes in personnel policy and you could potentially save your company. This informative seminar helps you learn the basis of good policy and the importance of enforcing it consistently. There are basic rules you must know about workplace grievances and disciplinary issues to limit or avoid negative action altogether, especially litigation.

Grandma was right, you know. An ounce of prevention is worth a pound of cure.

Bulletproofing Personnel Policies Against Litigation is presented by Jay Rush, Director of Contracts & Legal Compliance, of Policy Technologies International. For more details please visit our web site www.fxconferences.com