Finding the Optimal Regulatory Pathway for Your Combination Product

is being presented by Suzanne O'Shea, Of Counsel, with Baker & Daniels, LLP and airs on Thursday, September 15th, 2011. For more details, or to register please visit our site at www.fxconferences.com

Some view combination products as double the burden, but they also represent an opportunity for creativity and flexibility. And within the complexities of combination products, it is still possible to tailor a regulatory pathway that best meets your specific needs.

This audio conference presentation discusses marketing applications, how many are required and how many would best serve your needs. It also looks at whether the device component of a drug – device combination product can serve as a barrier to generic drug market entry. Our speaker also addresses the issue of cross labeling -- what is it? Is it still a possibility? The presentation explores the flurry of recent guidance documents on companion diagnostics, chemical action, and classifying products as drugs or devices. Do they help or hinder? The presentation provides attendees with a solid understanding of these topics, the possibilities arising from combination product innovations, and the current regulatory environment.

Update on Asia Pacific Device Regulation & Harmonization

is being presented by Jeremy Yung, Regulatory Affairs Associate, with ArthroCare Asia Pacific and airs on Wednesday, May 11th, 2011. For more details, or to register please visit our site at www.fxconferences.com

The regulatory environment for medical devices in Asia Pacific has changed significantly in the last five years. Countries that had little or no regulation have now implemented full pe-market reviews, quality systems control and post-market enforcement.

This audio conference presentation provides a country-by-country overview of the changes that have taken place in recent years, and what device companies can expect moving forward. Our speaker discusses the primary Asian markets, and the steps being taken by countries in this region to harmonize and increase the efficiency of device registration. The presentation reviews these developments in detail, and weighs in on how this new landscape will affect life sciences companies in the future.

Beyond Using SharePoint to Manage Regulatory Documents

is being presented by John Postle & Kent Fernald, Vice President, Life Sciences & Development Manager/CTO, of Court Square Group and airs on Wednesday, March 16th, 2011. For more details or to register for this event, please visit our site at www.fxconferences.com

Pharmaceutical and biotech companies have been facing increasing demands to improve their organizational effectiveness through information sharing and collaboration. At the same time, there is an important need for a controlled document management system that is compliant with FDA regulations. In this conference, our speakers not only look at the steps that have been successful for designing, configuring, and implementing Microsoft SharePoint within the confines of a regulated environment, but also review organizational collaboration features (wikis and blogs) and document workflows that organizations are using.

Speakers John Postle and Kent Fernald explain how to achieve ongoing compliance through the use of SharePoint as a validated application in a qualified environment. They also present real-life examples of several regulatory compliant business applications that have been developed using the SharePoint platform.

Intended Use & Indications for Use – Does Anyone Know What They Mean? Does FDA?

is being presented by Robert J. Klepinski, Regulatory Attorney, Of Counsel, with Fredrikson & Byron and airs on Thursday, January 13th, 2011. For more details or to register, please visit our site at www.fxconferences.com

Intended use. Indications for use. For years FDA has developed working definitions of these two terms, which vary from the definitions included in the regulations. Now FDA is questioning whether new definitions are needed. Previous industry use of the terms was based upon FDA's informal guidance, but if FDA doesn't know what they mean, does anyone?

In this audio conference, regulatory attorney Bob Klepinski discusses both the practical and the theoretical issues surrounding these two important terms and their use. The presentation looks at the statutory and regulatory definitions, and FDA's attempts to define them in guidance for industry. It also looks at what the future might hold, and how companies should proceed in the interim.

Regulatory Framework to Support Biomarker Development: EU & the USA

The European and US regulatory authorities recognize the potential of biomarkers to support the clinical and nonclinical development of medicinal products. Guidelines to clarify regulatory expectations have been published and both EMEA and FDA have developed procedures for companies to obtain input and advice on biomarker development. Importantly, those same regulatory authorities have both also formalized qualification procedures that result in an opinion on the acceptability/suitability of a biomarker.

This audio conference provides an overview of the EU and US biomarker qualification procedures. The speaker explains the steps involved, the data package required, and provides insight into why going through these procedures can add significant value with regards to investment opportunities, partnering and licensing deals.

Regulatory Framework to Support Biomarker Development: EU & the USA is being presented by Dr. Patricia Hurley, Head of Project Management and Biomarkers Division, with ERA Consulting (UK) Ltd. and airs on Thursday, January 21, 2010. For more details or to register, please visit our site at www.fxconferences.com

The ABCs of FDA: Regulatory, Fraud and Abuse Issues

More and more companies are venturing into medical devices, drugs or biologics in an effort to diversify or to promote new biotechnologies. At the same time, the United States government is taking a more active role in regulating the manufacturers, providers and payers in the healthcare industry. The collision of these two trends – increased interest in marketing healthcare products along with increased government involvement in regulation and enforcement – require companies to attain FDA regulatory compliance and prevent fraud and abuse violations in order to be successful in this industry and avoid multi-million dollar fines and penalties.

In this audio conference, the speaker addresses the basic things that people and companies need to know about dealing with the FDA and succeeding in the life sciences industry.

The ABCs of FDA: Regulatory, Fraud and Abuse Issues was presented by Bethany Gilbert, with Hodgson Russ LLP and aired on 2008-05-15. For more details, or to download this event please visit our site at www.fxconferences.com

Device Design in the Current Regulatory Climate

The current regulatory environment is dominated by post-market issues. Recent high-profile drug recalls have caused physician groups, Congress, the press and FDA to take new interest in post-market issues. To survive and prosper in this environment, medical device designers must recognize and accept several key truths.

Unlike drug molecular design, device design is an evolving process, not a one-time event. Also, a medical device is not just hardware, as the product labeling determines its use and its regulatory status. The associated service and customer care can make the difference between success and failure. Therefore, each post-market event causes you to look back into your design process; how far back and in what detail to do so are the key process issues.

This presentation discusses the increase in post-market scrutiny, how it came about, and how device designers can best deal with it.

Device Design in the Current Regulatory Climate was presented by Robert J. Klepinski, with Fredrikson & Byron and is previously recorded. For more details, or to download this event please visit our site at www.fxconferences.com

Preparing the Clinical and Regulatory Master Plan

Developing an accurate clinical and regulatory master plan is the key to getting any new drug or device product to the global marketplace quickly and in a cost-efficient manner. The master plan provides an invaluable roadmap of what needs to be done, and will also be used as a business plan in dealings with your notified body and potential investors. In this audio conference, our speakers discuss not just planning for CE marking, but incorporating the overall global market access into one plan. Attendees learn how key parameters and claims are defined, which is an important starting point.

The presentation also covers how to ensure compliance throughout the regulatory pathway to the global market, and how to ensure there is sufficient data available for immediate success of your products in global markets.

Preparing the Clinical and Regulatory Master Plan is being presented by Efraim Roe Kozorovitsky & Dr. Sunita Ahir, Executive Director, Medical Devices & Manager, Regulatory Affairs, with Premier Research and airs on Thursday, September 24, 2009. For more details or to register, please visit our site at www.fxconferences.com

Regulatory and Scientific Considerations for API Drug Development

The establishment of a robust Active Pharmaceutical Ingredient (API) development program is an integral part of drug development. A well-planned API development program that is properly integrated with the drug product, clinical, non-clinical and marketing programs is essential to prevent delays that can result in lost time, revenues and market life cycle.

This audio conference provides an overview of the scientific, regulatory and compliance requirements of API development at the various phases of development. The speaker also discusses special considerations associated with API development such as APIs manufactured from biological sources, the use of DMFs, and the management of manufacturing contractors.

Regulatory and Scientific Considerations for API Drug Development is being presented by Dr. William Putnam, Director, Executive Consultant, Scientific Consulting, with Beckloff Associates, Inc. (a Cardinal Health company) and airs on Wednesday, August 26, 2009. For more details or to register for this conference, please visit our site at www.fxconferences.com

Conducting Exploratory Trials in Scandinavia

Debating where to take your clinical trial? While emergent research settings like India and Asia have captured much of the media spotlight in recent years, there are few places in the world better-suited for phase 1 and phase 2 clinical trials than Scandinavia. .

Populations in the Nordic region are ethnically homogeneous with a majority being caucasian. Governments and populations both display a positive attitude toward clinical research, with high compliance rates by trial participants. All citizens have free and equal access to healthcare, preventing sampling bias due to differences in social status. Health care facilities in the region have first-rate infrastructures and access to state-of-the-art medical equipment. In comparison to other countries, trial costs can also be cut in half..

In this audio conference, the speaker discusses these and other factors that make the Scandinavian countries a leading choice for exploratory trials.

Conducting Exploratory Trials in Scandinavia was presented by Dr. Claes Strom, Partner and COO, with aCROnordic and aired on 2008-10-30. For more information or to purchase a download of this conference, please visit our site at www.fxconferences.com

Securing Regulatory Approval for IVDs in China

With a population of 1.2 billion people and growing, China has emerged as a major consumer of healthcare products and one of the most lucrative markets for medical devices and IVD products. Following several years of double-digit growth, recent estimates put the value of the Chinese IVD market in the range of 1.5 billion dollars. However, entering the Chinese market requires no small amount of forethought and planning.

This audio conference discusses the latest organizational chart for the key departments in the SFDA, as announced September 2008, and give insight into hot topics and trends affecting the Chinese healthcare system.

Securing Regulatory Approval for IVDs in China was presented by Janice Ma, Managing Director, ChinaGate and aired on 2009-02-19. This conference is available for download at www.fxconferences.com

Meeting the Challenges of Global Oncology Trials

Successful global oncology trials require careful planning, starting with looking at the strategic elements that span people, process and technology. Challenges in clinical research in oncology today include multiple new agents for multiple new targets combined with an increase in the number of patients needed to demonstrate that a therapy provides a significant benefit for patients. There is also a need to minimize the time it takes to go from basic science discoveries into clinical studies. The risk posed by delays in study start-up and patient recruitment can be mitigated by proactively planning for the study.

Planning needs to reflect the traditional and nontraditional considerations of feasibility and study design and incorporate trends and best practices. Patient recruitment is a key strategic consideration, along with epidemiological and genetic factors. Facilities, expertise and other resources along with technology play a key role in global trial planning.

Area-specific regulatory requirements vary in terms of standards of care, and differences among healthcare systems influence trial planning, as do local and cultural considerations.

This presentation focuses on the central challenges in global oncology trials today and make recommendations about how they might be addressed to mitigate risks in terms of timelines and costs.

Meeting the Challenges of Global Oncology Trials was presented by Dr. Ute Berger, Senior Director of Therapeutic Expertise Oncology & Hematology, with PRA International and is available for download 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

Proteomics Role in Biomarker Discovery and Validation

Regulatory agencies continue to support the use of biomarkers and encourage biotech and pharmaceutical companies to have a biomarker strategy for all compounds. Biomarkers can play a significant role in identifying signal in early compound candidates as well as clinical targeting and stratification of efficacious populations.

We’ll examine proteomics role in the identification of novel protein biomarkers and subsequent high-throughput assay development and validation that can significantly reduce risk and enhance clinical development productivity and decision making in Pharmaceutical research.

Proteomics Role in Biomarker Discovery and Validation is being presented by Dr. Daniel Chelsky, Chief Scientific Officer with Caprion Proteomics and airs on Wednesday, February 11th, 2009. For more details or to register for this event, please visit our site www.fxconferences.com

Successful Medical Device Approvals in China

With over 1.4 billion people and an emerging public healthcare system, China is one of the most attractive secondary markets for medical device manufacturers worldwide. The regulatory requirements mandated by the State Food and Drug Administration (SFDA) have been evolving. In this audio conference, our speaker discusses the background of SFDA regulatory requirements and explain the process of registering your product in China, including specific information on how the SFDA defines and classifies a medical device, the registration dossier required by SFDA, regulatory criteria for testing and clinical trials. The presentation also provides examples of what has helped companies succeed in achieving approvals, and discuss the latest trends in the China regulatory environment.

Successful Medical Device Approvals in China was presented by Janice Ma, Managing Director, with ChinaGate and aired June 19th, 2008. For more details, or to listen to a sample clip, please visit our site www.fxconferences.com

Determining Feasibility in Global Clinical Trials

The single greatest challenge to drug development today is successful patient accrual. The sheer volume of actively recruiting trials advertised by the NIH -- nearly 16,000 in 2006 -- illustrates the extensive competition for patients to participate in clinical trials in the United States. In an effort to access more patient populations to address these issues, it has become necessary to include a global mix of countries.

The key to including sites outside the United States is understanding exactly where the selected patient populations are located. Detailed feasibility is a critical step to planning and conducting successful global clinical trials. Understanding the medical standards of care, local healthcare systems, national health insurance and reimbursement, drug importation and tax implications, local regulatory requirements and treatment paradigms are all essential to determining where globally to place a specific clinical trial.

This presentation focuses on how to perform global feasibility to aid in the planning and conduct of clinical trials to economize your development times and clinical trial costs and explores the benefits of including regions such as Eastern Europe, Latin America, Asia and India.

Determining Feasibility in Global Clinical Trials aired on 2007-08-02 and was presented by Kent Thoelke, Sr. Vice President, with PRA International. For more details please visit our site www.fxconferences.com

Global Regulatory Teamwork Strategies

Are you in the process of putting together a team to take your products or services global? Unsure where to begin? Global teams have become the norm in the life sciences industries. When they work well, these teams can bring new products to markets all around the world in record time. But when they don't work well, global teams can end up operating as a collection of national sub-teams that ignore or even compete with one another.

How do you build effective, cohesive global teams in the device, diagnostics or pharmaceutical industries, while avoiding the costly mistakes that can lead to dysfunction -- or worse! Join us and get the answers you need!

Global Regulatory Teamwork Strategies was presented by Dr. Lionel Laroche, Executive Vice President, with CPI Hazell & Associates and is available for download at www.fxconferences.com

Global Unifying Trends in Device Regulation

Device manufacturers who want to reach world markets are faced with a plethora of regulatory schemes that appear to be disjointed and unconnected.

Although, at first glance, this may be true, there are some harmonizing influences afoot that wise manufacturers can take advantage of in marketing their products across the globe. The audio conference with explore these possibilities.

Global Unifying Trends in Device Regulation was presented by Harvey Rudolph, PhD, Global Program Manager, of Underwriters Laboratories on 2005-04-13. For more details on this audio conference, or to purchase a download, please visit our site www.fxconferences.com

An Introduction to Regulatory Writing: Creating an Effective Message

Did you ever wonder what reviewers look for in your regulatory submissions? This audio conference combines the results of two in-depth interviews regarding effective writing in regulatory submissions and with known effective writing techniques and practices. The interviews were with a previous FDA reviewer and a current reviewer for a large Notified Body. Both interviewees shared their reactions to the quality and effectiveness of the writing in the hundreds of submissions they have each reviewed.

Topics include: analyzing the audience, identifying topics, organizing the topics in a logical way, applying document design principles, establishing document management conventions, writing, and assessing the effectiveness of your writing.

An Introduction to Regulatory Writing: Creating an Effective Message is being re-broadcast on Tuesday, October 21st, and is presented by Nancy Hoft, of Nancy Hoft Consulting. For more details or to register, please visit our site at www.fxconferences.com

The ABCs of FDA: Regulatory, Fraud and Abuse Issues

More and more companies are venturing into medical devices, drugs or biologics in an effort to diversify or to promote new biotechnologies. At the same time, the United States government is taking a more active role in regulating the manufacturers, providers and payers in the healthcare industry. The collision of these two trends – increased interest in marketing healthcare products along with increased government involvement in regulation and enforcement – require companies to attain FDA regulatory compliance and prevent fraud and abuse violations in order to be successful in this industry and avoid multi-million dollar fines and penalties.

In this audio conference, the speaker will address the basic things that people and companies need to know about dealing with the FDA and succeeding in the life sciences industry.

This event is presented by Bethany Gilbert of Hodgson Russ. To learn more, please visit www.fxconferences.com.