The Crime of Counterfeiting: Implications and Staying Ahead

The prevalence of counterfeit healthcare products on the market is increasing, especially in developing countries. Some of these products are difficult to identify and all are potentially unsafe. Nonefficacious versions of lifesaving products; nonsterile, substandard devices; and products with poisonous ingredients all jeopardize public health and safety. This session is aimed at understanding intellectual property crimes and combating counterfeiting of healthcare products.

You will hear from experts who have been faced with the challenges of protecting the public health, preserving their businesses and devising ways to stay ahead of the counterfeiters. In addition, you will learn product protection and identification techniques, approaches and strategies for operational security, industry partnerships, supply chain management and cooperation with national and international agencies.

The Challenges of Nano: Navigating the Field and the Regulatory Pathways

Nanomedicine, an offshoot of nanotechnology, refers to highly specific medical intervention at the molecular scale for curing disease or repairing damaged tissues, such as bone, muscle or nerve. Nanomedicine and nanotechnology remain on the cutting edge of the healthcare product industry and it is important to stay current to understand how to strategically align your business with this exciting new field.

Experts will discuss the growing nanomedicine/nanotechnology field and the challenges involved in developing these products and navigating the regulatory pathways toward commercialization.

Telemedicine: Getting Connected

Harmonization by Doing: Medical Device Development in Japan

Efforts between healthcare product regulatory agencies in Japan and the US to end the “device lag” are gaining increasing visibility in both countries.

This session will focus on business and device regulatory strategies in Japan, highlighting the Harmonization by Doing (HBD) initiative and simultaneous clinical trial and regulatory approvals. You will hear first-hand updates from leaders within the Japanese Ministry of Health, Labour and Welfare and the US Food and Drug Administration on HBD progress thus far and initiatives for the future. This is an essential topic with which regulatory professionals in all areas should be familiar.

Pharmaceutical Product Divestiture and Deletion: What You Need to Know

The end of direct involvement with a major product through either patent expiry or a strategic exit may give the false impression that regulatory responsibilities cease. This is not the case—regulatory responsibilities may, and often do, increase.

This session will discuss what happens when a product reaches the natural end of its life. It will also cover those steps that minimize corporate commitments to a product as it is globally divested and deleted from the corporate portfolio.

Health Hazard Analysis in the Global Marketplace: Advice from the Experts

Identification and management of a product’s hazard potential is a fundamental element of the risk management program—and a regulatory requirement.

In this session you will hear from industry, US Food and Drug Administration and EU experts on important elements and considerations in preparing a Health Hazard Analysis (HHA). You will learn how to avoid pitfalls that can result in global compliance problems and lead to recalls. You will hear first hand how FDA performs its own HHA for critical devices. This session will offer valuable insights from experts that are a must for today’s regulatory professional in the global marketplace.

EU & US Pharmaceutical Electronic Submissions: Experiences to Help You Develop Strategy

The electronic common technical document (eCTD) is evolving into the preferred format for drug submissions. Industry solutions are becoming more numerous and robust as the regulatory profession adjusts to the complexities and nuances of different regional requirements.

Learn about the present status of electronic submissions in the EU and US. Hearing directly from the speakers on what works and does not work will provide you with insight into the acceptability of the submission in the eCTD format and other aspects of this rapidly changing initiative.

Regulatory Challenges for Pediatric/Humanitarian Use Devices

Distinctive challenges face healthcare product developers of pediatric and humanitarian use medical devices. Patient populations are small and sometimes seen as vulnerable. Often with one-of-a-kind products, the regulatory pathway is new and unexplored. Premarket obstacles may seem daunting, but providing safe and effective products that fill unmet needs to these patients is a unique opportunity.

Experts will provide insight into the complex regulatory framework for these products. The session will examine human factors issues, clinical trial considerations and various opportunities to comply with global regulatory challenges.

Emerging Markets: Medical Devices in Latin America and Asia

Regulatory professionals in the medical device industry must be able to navigate a global regulatory landscape that is challenging, but that offers many opportunities for growth and success.

This session will provide insight on how device manufacturers can penetrate the device market in both Latin America and Southeast Asia by defining well-established regulatory strategies and product development plans that take into consideration standard requirements. Speakers will share in-depth analyses and regional comparisons of global regulatory and business strategies for working in these emerging markets.

Connecting Business and Regulatory Strategy: The Key to Long-term Success

Global regulatory requirements for healthcare products can wreak havoc with a corporate business plan. Marketing wanted it yesterday, the new product team is behind schedule and the application hasn’t even been submitted. Sound, comprehensive planning with a global outlook, presented to the business leaders as part of the business planning cycle, can help prevent surprises. Formulation and implementation of an effective regulatory strategy and a robust business strategy are critical to a product’s success and, ultimately, a company’s long-term success.

In this session, you will learn to integrate and manage a comprehensive business strategy, including identifying and communicating regulatory risks, evaluating financial impact and incorporating global launch plans. Regulatory and business experts will share experiences that will help you avoid pitfalls, gain insights into the financial and global aspects of profitable companies, utilize regulatory intelligence in your decision-making process and plan for a successful product.

Business Continuity Management (BCM): The Role of the Regulatory Professional in Disaster Planning and Pandemics

Your organization can be threatened by many risks that can disrupt your business processes. Such risks can include more traditional emergencies like fires, floods, earthquakes and tornadoes as well as risks from physical and cyber terrorism, cybercrime, potential pandemics, computer and telecommunications failures, and other events. Any one of these has the potential to negatively impact the flow of business.

This session will review the concept of BCM in terms of reducing risk, satisfying customer requirements, staying competitive and winning new business. Speakers will emphasize the regulatory professional’s role in disaster planning and surviving global disasters and pandemics.

Avoid a Warning Letter: Practical Solutions for Compliance around Supplier Quality Management

The current regulatory and quality assurance requirements for medical devices (including ISO 13485) place significant emphasis on medical device manufacturers’ responsibility for outsourced processes provided by suppliers and subcontractors. Hence, there is increased attention to supplier quality management. Recent FDA Warning Letters emphasize that this is an important area of focus to regulatory authorities.

This session will give an enhanced assessment of current regulatory and quality assurance requirements regarding supplier quality management and discuss practical solutions for achieving compliance with those requirements. The session will provide thoughts on effectively managing medical manufacturer responsibility for maintaining control over suppliers and the consequences of supplier problems.

Clinical Trial Registries and the Impacts of FDAAA 2007: Insights and Strategies

Section 801 of the Food and Drug Administration Amendments Act of 2007 requires the expansion of the ClinicalTrials.gov registry to include the basic results of all registered clinical trials, and was mandated as of 27 September 2008.

This session will offer insight and strategies for effectively posting trial results and coping with operational issues and challenges related to this significant change.

Regulatory Approaches to Combination Products Involving Medical Devices and Tissues/Cells or Blood Products

Regenerative medicine offers the potential cure of virtually any disease resulting from malfunctioning, damaged or failing tissues through regenerative medicine therapies, by either regenerating the damaged tissues in vivo, or by growing the tissues and organs in vitro and implanting them into the patient. Many of the therapeutic approaches in regenerative medicine combine medical devices that provide scaffolds or three-dimensional supports for the growth of human tissues and/or stem cells into the healthy tissues.

In this session, experts and participants will discuss regulatory requirements and successful approaches to combination products, specifically those involving human cell- or tissue-derived scaffolds, stem cell-based regenerative medicine and advanced therapy for medicinal products in the US and EU. Import/export requirements for human tissues, vaccines and blood products of the US and EU will also be discussed.

Crisis Management for Senior Level Regulatory Professionals

All regulatory professionals recognize that when dealing with regulatory agencies, the medical community, the public and the press, a crisis is almost guaranteed.

In this session, experienced regulatory and medical professionals will describe methods to best handle a crisis with minimal disruption and maximum benefit.

Risk Analysis in a Comprehensive Medical Device Risk Management System

Risk analysis is a critical component of a comprehensive risk management system. By applying risk analysis tools and methods to integrate hazards arising from product design, manufacturing processes and controls, user applications and environments, and quality system hazards, a comprehensive risk analysis program can be developed.

This session reviews risk analysis in the risk management process, including an emphasis on models, tools and strategies, applying ISO guidelines. Participants will gain an understanding of guidelines for developing robust risk analysis tools and methods that can be utilized to mitigate key risks throughout the product lifecycle.

Understanding the Line Between Regulatory and Legal:…And What Happens When you Cross Over It

FDA practice combines technical and scientific issues under the umbrella of the law. In this merged world, regulatory consultants and regulatory lawyers often seem to occupy the same space. Yet certain tasks are best performed by regulatory consultants and other tasks are best performed by, and, in some cases, may only legally be performed by, lawyers. Understanding the line between these two professions is critical. The failure to do so can result in suboptimal client service and legal risks to both the consultant and the lawyer.

This session delineates appropriate regulatory consulting from the practice of law, will help consultants identify when to bring lawyers into a project or issue, will help identify when a lawyer should bring a regulatory consultant into a situation, and will help lawyers and consultants work together to combine the expertise of each.

Delving into the Regulatory Considerations of Targeted Therapy Innovation

The impact of personalized medicine on healthcare and the pharmaceutical industry has increased and will continue to do so. Current "targeted" therapies have shown that drugs designed to interact with specific molecular targets can have a definite impact on certain diseases like cancer. However, targeted therapies are no panacea. To continue advancing treatments, industry and the research community must continue to improve their understanding of specific drug targets. This, and other types of personalized medicine, may determine which treatments will be most beneficial to people based upon genomic signatures.

This session delves into this innovative area of development by investigating ethical issues, pharmacogenomics/pharmacogenetics, clinical trials strategies and financial aspects.

The Impact of the Amended EU Medical Device Directive and European Commission Consultation

European Commission (EC) Directive 2007/47/EC has amended the Medical Devices Directive (MDD), affecting medical device manufacturers needing to maintain or obtain CE Marking for devices intended to be placed on the EU market. Furthermore, the EC has begun a consultation process on the need for a more radical recast of European medical device regulations.

This session will discuss the impact of the current MDD amendment and its effects on medical device manufacturers exporting to the EU as well as the expected changes to conformity assessments by Notified Bodies. The session will also consider the EC recast consultation and provide the latest insights/predictions to longer-range EU medical device regulation.

Corporate Social Responsibility

Corporate decision-making must incorporate a multifaceted approach to running a business, including environmental, financial and social aspects. Corporate social responsibility (CSR) is increasingly important for a company’s bottom line and many challenges await organizations that commit to this strategic tool.

This session will focus on team performance and collaborative strategies to succeed in business. Speakers will impart valuable skills for effective planning and team-building.