2011 RAPS Tracks

Biologics/Biotechnology  |  Clinical  |  Compliance  |  Electronic Intervention
Health-Related Foods  |  Medical Devices and In Vitro Diagnostics (IVDS)
Pharmaceuticals  |  Regulatory Business

Biologics/Biotechnology

Nearly 28% of regulatory professionals work with biological products. The biologics and biotechnology track addresses a range of topics relating to blood, vaccine, cellular, gene and tissue products as well as the scope of responsibility for regulatory professionals working with these products in an increasingly complex global regulatory environment. This track includes industry and agency perspectives highlighting the special characteristics of biologic drugs and the challenges associated with their development.

Clinical

The clinical track reviews global topics including principles, concepts and recent issues regarding clinical research on drugs and devices throughout all development phases. It addresses ethical and legal issues within the clinical trial process, trial conduct, data collection and the maintenance of quality, safety and compliance. Speakers within this track offer perspectives from industry, agencies, sponsors and clinicians worldwide.

Compliance

Regulatory compliance experts from industry, consultancies, agencies and law firms present perspectives on topics such as registration requirements, Good Clinical Practice (GCP), Good Manufacturing Practice (GMP) including supplier management and controls and auditing, postmarket surveillance, good documentation practices, ethical considerations and avoiding pitfalls across a full range of healthcare product types including Drugs, Devices and Biologics.

New! Electronic Intervention

The focus of this track is on the relentless convergence of information and communication technologies across healthcare delivery and life science functions, and the resulting regulatory challenges this convergence represents.

Health-Related Foods

Experts from industry, agencies and law firms present perspectives on topics such as foods and global borderline issues with drugs, cosmetics, botanicals and food supplements; food safety; regulatory forecast for claims and content of probiotics and regulatory environment of selected geographies for foods with medical purposes.

Medical Devices and In Vitro Diagnostics (IVDS)

Today, more than 55% of regulatory professionals work with medical devices and nearly 14% work with in vitro diagnostic (IVD) products. The medical devices and IVDs track addresses how global trends, emerging markets, and agency guidance changes impact the regulatory professional throughout the product lifecycle. Speakers from industry, international agencies and notified bodies will be invited to share their perspectives.

Pharmaceuticals

The pharmaceuticals track addresses a range of current themes for professionals working with innovative drugs, generics, and OTCs, and covers topics relevant to research and development, regulatory strategy, risk management & risk communication, global supply chain challenges, drug naming issues & strategies, and speeding access to therapeutic goods in a complex global regulatory environment.

Regulatory Business

Regulatory professionals must gain an understanding of business principles, concepts, insights and strategies throughout their careers because about a third of their time is spent on business and regulatory strategy. Topics within this track address partnership and interaction with business colleagues, developing a consulting practice, the impact of regulatory milestones on business performance, the role of regulatory in startup venture companies and large public companies, the business of pharmacogenomics and individualized medicine, communication strategies and performance measures.