Tips and Tricks for Effective eCTD Regulatory Strategy and eCTD Lifecycle Management

is being presented by Gina Ross, , Director, Quality Document Systems Management, with Beckloff Associates and airs on Tuesday, Novemeber 30th, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com

A sound regulatory strategy, combined with proactive lifecycle management of electronic submissions, can speed the regulatory review and approval process and reduce the regulatory burden, expand marketing applications to additional jurisdictions and drive successful regulatory approval outcomes.

To be truly successful at integrating regulatory strategy and eCTD lifecycle management, sponsors need to evaluate their existing document authoring and submission compilation activities and determine what, if any, modifications are necessary to accommodate the eCTD specifications. Document authors need to understand not only the CTD guidelines, but also have a working knowledge of the eCTD guidelines and application of the lifecycle operation attributes. Regulatory affairs and regulatory operations (i.e. publishers) need to have an in-depth knowledge of the CTD and eCTD guidelines, as well as the electronic requirements of multiple global regulatory agencies.

This audio conference is designed to help organizations and individuals understand the relationship between regulatory strategy and the eCTD lifecycle management, and to effectively develop systems, processes and procedures to support the chosen strategies and facilitate the future lifecycle management of applications.

Nanotechnology – Current Regulation and Future Prospects

is being presented by Dr. Tony Lockett, Medical Director, with Information Change Organisation Ltd and airs on Thursday, May 20, 2010. For more details or to register, please visit our site at www.fxconferences.com

Nanotechnology is an emotional subject for a public concerned about the perceived threat from so-called frankenfoods. The initial response from government has been to do nothing specific, and until recently drugs based on nanomaterials were treated as new chemical entities (NCE). This has led to a considerable delay in the development of nanomaterials – particularly those for medical uses, where full toxicological assessment was often required prior to using these materials in humans.

There are signs that this is changing. The realization that many nanoparticles are in fact natural, and that materials can self assemble in biological systems, has forced a change in the way we think about nanotechnology. However, there is widespread concern over development of national policies to control this technology, and many fear local regulation will lead to commercial interests being put before safety and efficacy. They believe transnational regulation is required – similar to that exercised by the International Conference on Harmonization with regard to pharmaceutical development – to counterbalance commercial interests.

This audio conference presentation will provide an overview of current regulations governing nanotechnology, and discuss future regulatory strategies.

Off-Label Information: Regulation & Dissemination

Off-label promotion is a perennial hot topic within the life sciences. The rules can appear ambiguous at times, but the consequences of running afoul of FDA are serious indeed. In this audio conference, our speakers provide background information and examine the current regulatory status of off-label promotion of drugs and medical devices. The presentation also looks at the "how-tos" for dissemination of off-label information; the role of sales representatives and medical science liaisons (MSLs), and the practical application of the FDA's January 2009 guidance on reprints.

This session also examines the consequences of off-label promotion, reviews some actual enforcement actions taken against life sciences companies by FDA, and the roles of the Office of the Inspector General, U.S. Attorney's Office and state governments.

Off-Label Information: Regulation & Dissemination is being presented by Caryn Silverman & Soo Kim, Partner & Senior Associate, with Sedgwick, Detert, Moran & Arnold LLP and airs on Thursday, September 3, 2009. For more details or to register for this event, please visit our site at www.fxconferences.com

Clinical Trial Insurance: Managing Common Problems and Pitfalls

Proof of clinical trial insurance is often a requirement in order to initiate clinical trials. However, obtaining such proof - normally in the form of an insurance certificate - is not always a straightforward process. This presentation explores the reasons behind that, and examines why there is no consistent approach across territories for the same trial/protocol. It also examines the implementation of the European Clinical Trials Directive and the resulting frustrations felt by purchasers of insurance in terms of delay, administration and cost.

In this audio conference, the speaker looks at how the law/regulations, practical requirements, information requirements and insurer approaches can differ by territory, and draws upon extensive experience to put forth some methods of managing this and avoiding pitfalls along the way.

Clinical Trial Insurance: Managing Common Problems and Pitfalls is being presented by James Bird, Partner, with Jardine Lloyd Thompson and airs on Tuesday, September 29, 2009. For more details or to register for this event, please visit our site at www.fxconferences.com

Meeting the Requirements: Blending REMS Science & Operational Execution

We invite you to listen to the PRA Risk Management, Epidemiology and Late Phase Operational experts who are currently consulting, designing and conducting REMS activities under the new FDAAA regulations. These experts give insight into current issues concerning REMS, such as risk management activities, observational safety-surveillance studies and performance-linked access programs. They also discuss the potential payoff from the new REMS requirements, as well as which REMS requirements have been proposed for incorporating adaptive designs.

In this audio conference the speakers present various REMS strategies based on a “tiered” approach, as well as some recent case studies. In addition, the presenters cover lessons learned and program components to consider, based on current FDA thinking and requirements for a REMS.

Meeting the Requirements: Blending REMS Science & Operational Execution is being presented by Mark Nelson Tyrrell, Kathleen Kushner & Jerome Wilson, Director, Safety and Risk Management, Scientific Affairs Director & Senior Scientific Affairs Director, with PRA International and airs on Tuesday, June 16, 2009. For more details, please visit our site at www.fxconferences.com

Regulatory Considerations for R&D in Central & Eastern Europe

Central and Eastern Europe continues to be an attractive place for conducting clinical trials, with rapid patient recruitment and high quality of data. At the same time, the clinical trial industry's single greatest challenge continues to be the regulatory process, which has a key impact on the duration of the study start-up period and on timely patient recruitment.

Regulatory requirements in CEE countries went through dynamic changes within the last couple of years, mostly as a result of the accession of several countries to the European Union, as well as increasing demand for the adjustment of local regulations to international standards coming from the pharma industry. However, regulatory changes still seem to be an ongoing process, and the greatest challenge for sponsors and CROs.

This presentation focuses on major regulatory-related problems, with special attention to site contracting problems, and show practical ways of overcoming them in order to speed up the drug development process.

Regulatory Considerations for R&D in Central & Eastern Europe is being presented by Dr. Malgorzata Szerszeniewska, CEO, with Unimed and airs on Tuesday, July 7, 2009. For more details, please visit our site at www.fxconferences.com

Regulation vs. Communication: Finding the Balance

It's no wonder pharmaceutical companies are hyper-focused on regulatory compliance. For the first time ever, a physician was indicted for off-label promotion (Xyrem, Gleason; case pending). Over the past two years, off-label promotion fines increased from $3 to $5 billion. Even company executives have been personally fined (Purdue Frederick, guilty plea, $38M).

At the same time, the need to reduce the morbidity and mortality associated with chronic disease has driven investment in consumer and patient education about illness and drug treatment. Spending on DTC advertising increased by 330% from 1996 to 2005 (NEJM). Spending on eMarketing/promotion will reach over $480m by 2011 (Visiongain).

It's a double-edged sword. Companies cannot afford to pay the price for noncompliance (e.g. legal fees, criminal prosecution, corporate integrity agreements, and negative media attention). Yet, to maximize health outcomes, marketing communications must ensure that the messages break through at a time and place where patients can hear them. Prime example: social networking, which has opened the door for more participation and spontaneous emotion. How does the industry stay compliant and be creative at the same time? In the end, we owe it to ourselves, our associates and our organizations to deliver on this goal within an ever more restricted regulatory environment.

Regulation vs. Communication: Finding the Balance was presented by Ilyssa Levins, President, with HCIL Consulting and aired on 2008-01-10. For more details or to purchase a download of this event, please visit our site www.fxconferences.com

Japan's Revised PAL: What Device Companies Need to Know

In 2002, the Japanese Ministry of Health, Labour and Welfare announced sweeping changes to its Pharmaceutical Affairs Law and the regulations governing the sale of medical devices in Japan. Japan represents a 10% share of the global medical device market, and it is vital that device manufacturers have a thorough understanding of the revised PAL if they wish to gain legal market entry.

This presentation gives an introductory overview of the structure of the Japanese regulations, and highlight the main requirements device companies must meet in exporting their products to Japan.

Japan's Revised PAL: What Device Companies Need to Know was presented by Steve McRoberts, Global Principal Engineer, Medical Regulatory Programs, of UL International (UK) Ltd. on 2006-01-11. For more details, or to purchase a download, please visit our site www.fxconferences.com