Pharmaceuticals: the Last Frontier for Package Design
Peter Clarke, CEO and Founder Product Ventures Ltd.

Hear from the CEO of leading product and packaging design and development agency, Product Ventures Ltd. Peter Clarke's presentation will draw on his significant experience working with a veritable who's who in global business, including companies such as PepsiCo, Nestlé, Novartis and Procter & Gamble.

Discover why the pharmaceutical industry is the "last frontier" when it comes to package design. Gain a better understanding of how consumer testing can increase compliance and efficacy for pharmaceutical manufacturers. Clarke's presentation considers such issues designing packaging for a global market; justifications for the cost of change; materials and package structures that could revolutionize pharmaceutical packaging; and how sustainability fits into the packaging equation.

A visionary entrepreneur, Clarke founded Product Ventures Ltd. in 1994 as a research, design and development consultancy for product and packaging innovation. He is a sought-after speaker and frequent editorial contributor. You won't want to miss this opportunity to access leading-edge ideas about the future direction of pharmaceutical package design.

Track-and-Trace and Anti-Counterfeiting Technologies for Pharmaceutical Packaging
Narendra Srivatsa, Business Development Manager, Cortegra

Counterfeiting of pharmaceutical products continues to increase and is a worldwide concern. While some pharmaceutical companies are using anti-counterfeiting technologies, many are waiting for an anticipated FDA mandate to provide unique IDs on packages. Confusion abounds as to which technology will prevail ñ RFID, 2D bar codes (driven by EU), or other options ñ delaying the implementation of the technical and business practices that will improve the safety of our drug supply. This session will examine the adoption of anti-counterfeiting technologies by brand owners, specifically unique item-level ID to combat counterfeiting.

How Better Packaging Can Increase Pharmaceutical Compliance
Peter G. Mayberry, Executive Director
Healthcare Compliance Packaging Council

Pharmaceutical noncompliance is estimated to drain some $200 billion from the U.S. economy each year. This is a global problem that impacts consumers from all walks of life and economic status. Peter Mayberry is the Executive Director of the non-for-profit association, Healthcare Compliance Packaging Council, and an expert in drug packaging issues. Heíll share independent research that illlustrates the huge scope of the pharmaceutical noncompliance problem and the impact that better packaging can play on reducing the problem.

Tassilo Korab, Executive Director of the European Healthcare Compliance Council, will update the audience on developments in compliance packaging throughout Europe, and will provide a special report from the European Parliament on strategies for combating counterfeiting. As a recognized expert in flexible packaging, Korab holds an MSc in Healthcare Economics, and has also written several publications on patient compliance, standards and regulations for child resistant packaging and the war against counterfeits.

Weijun Gu will present "Internationalization of Chinese Pharmaceutical Manufacturers - the Trend and the Drive." Gu is Secretary General of China Pharmaceutical Association of Plant Engineering, and is active as an advisor and board member for several companies and institutions. In 1990, he joined China National Pharmaceutical Foreign Trade and Cooperation (SinoPharm), where he spent eight years on import/export of pharmaceutical equipment and was involved in early joint ventures; he also spent four years in Europe and Hong Kong as trade representative of the corporation and is a recognized expert on internationalization.

In 2004, he was elected Secretary General of the CPAPE. Under his leadership, the CPAPE has attracted a good number of distinguished pharmaceutical engineers in China; works closely with Chinese and international regulatory authorities as well as the FDA, EMEA, SFDA, WHO, PDA, ISPE, and ASHP; and plays an important role in promoting manufacturing safety and medication safety in China.

P. Balagopal will be joining the panel discussion to share his professional insights on pharmaceutical manufacturing in India. Currently Senior Vice President Technical and Projects, Balagopal has been with Elder Pharmaceuticals for five years. Headquartered in Mumbai, Elder Pharmaceuticals manufactures a wide range of pharmaceutical products and active pharmaceutical ingredients and also has licensing agreements with international pharmaceutical companies. Balagopal's previous experience includes nearly two decades with GlaxoSmithKline Ltd. Throughout his career, his work has been in the area of capital purchases of packaging equipment and development of specialized machinery.

Ample time for questions and discussion will be included following the panel presentations. Don't miss this exceptional opportunity to gain insight and information about the worldwide pharmaceutical marketplace.

Packaging line performance expert Paul Zepf will offer a compelling presentation about the importance of OEE. Unplanned downtime, excessive changeover time, and failure to maintain production schedules are issues that can be resolved to significantly lower costs. Zepf has over 35 years of related experience, having designed and built dozens of one-of-a-kind packaging systems. He has written ten books on packaging production systems and is the acknowledged authority on packaging machine design, integration, process performance and project management. His presentation will include real world scenarios and strategies for improvement, specifically for pharmaceutical packagers.

Industry experts co-present in this session, detailing the revised JETT Risk
Assessment Model. JETT is a consortium of healthcare industry equipment
users, suppliers, and consultants seeking to improve communications between
users and suppliers to more effectively meet the validation requirements of
the industry. Equipment that is considered includes processing, primary
packaging, secondary packaging and labeling.

Although there exist many useful documents and seminars about how to do
various forms of risk assessment, some information is lacking. How and when
to start? When is the supplier involved? What are the roles of the user and
supplier and the inputs required? What output documents are to be generated?
This session, detailing the JETT Risk Assessment Flow Chart, will provide
direction and answers to these questions.

Packaging issues in clinical trials, combination products, and FDA insights
Michael Drues, President, Vascular Sciences

When it comes to conducting clinical trials, packaging is often the last thing on people's minds. But primary, secondary, and/or tertiary packaging issues can be critical to the success or failure of a new product, especially a clinical trial. If problems are discovered with a product in a clinical trial, how do we know if they were caused by the product itself, improper packaging or product handling? In this session, Mike Drues, president of Vascular Sciences addresses these issues and explores combination products and the key differences between biologics, drugs, and medical devices. Drues will also provide his unique perspective on working with the FDA.

You'll hear specific examples of new product introductions, market drivers, company response with hiring and reorganization, and the various roles of the pharmaceutical company versus the contract packager or contract manufacturer. Look for insights on validation, track and trace, and OEE. Ample time for questions and comments will be built into this session.