Conference Day One: Monday, 28 July 2008

08:30 Registration

09:00 Chairman’s Opening Remarks

Dr. Mithilesh Trivedi Vice President – QA & QC CALYX CHEMICALS & PHARMACEUTICALS LTD

Isaac Cohen Chairmen and CEO BIONOVO INC.

09:15 Latest Developments & Updates Of The Pharmaceutical Industry: The Key Implications For Stakeholders In The Value Chain

• What are the key regulatory updates in Asia?
• How GMP-ready are manufacturers in Asia?
• A comprehensive insight into the new pharmaceutical legislation and its subsequent implementation
• What are the implications for manufacturers and quality assurance heads?
• Aligning of EU & U.S. legislation with local requirements for the future

Prof Dr Ampol Mitrivej
Dean, College of Pharmacy
MAHIDOL UNIVERSITY

10:00 Understanding The Medical Legal Aspects Of GMP And Its Implications On Your Business In Terms Of Manufacturing Of Defective Components Or Goods

• Key updates of medical legal issues and its relation to GMP
• Understanding the implications of product liability laws for dangerous goods on your business
• Tort of negligence
• Duty of care
• Breach of standard of care
• Causation laws
• Understanding the impact of remoteness of damages on your product

Catherine Tay
Associate Professor, NUS Business School
NATIONAL UNIVERSITY OF SINGAPORE

10:45 Understanding GMP Requirements According To International Guidelines

• Examining the principle of GMP
• Why the need for GMP?
• Benefits and importance of GMP
• Maintaining Quality Standards according to international regulatory guidelines

Mai T Ong
Senior GMP Auditor
HEALTH SCIENCES AUTHORITY SINGAPORE

11.45 Building And Equipment Design In Compliance With CGMP For A Biopharmaceutical Facility In Malaysia

• Concept of a cGMP compliant facility including design issues and layout
• Systems that must be in compliance and specific issues with each area/system
• Challenges to building in Malaysia, taking into consideration factors such as the local environment

Michelle Peake
Chief Operating Officer
ALPHA BIOLOGICS

13:30 Sensory Systems For Pharmaceutical Manufacturing

Pharmaceutical products of high quality standard are demanded by consumers as these products are often used by the less healthy of the population. Unfortunately, there has been a considerable number of product recalls worldwide due to manufacturing defects. The penalty for manufacturing errors is the significant loss of public and regulatory confidence in the manufacturer. This also leads to more stringent regulatory regulations across the entire industry and casts a negative cloud over new drug approvals. This presentation will discuss the implementation of sensing tools for PAT in pharmaceutical manufacturing and provide examples of how some PAT tools are employed for real-time monitoring of pharmaceutical unit processes using a combination of different techniques and the following:

• Tips to ensure continuous real-time monitoring of all pharmaceutical processes to successfully implement PAT and timely information for process monitoring and control
• How to identify critical process parameters and sensory tools for real time monitoring of these parameters
• Techniques to establish conformity with past production cycles where products of high quality were manufactured
• Understanding how sensing tools, when used within a system, can provide effective and efficient means for acquiring information to facilitate process understanding, develop risk-mitigation strategies, achieve continuous improvement, and share information and knowledge
• Outlining the tools and sensory systems needed for the “conscious” manufacturing process to assure the quality of products manufactured

Paul W S Heng Ph.D.
Associate Professor with the Dept of Pharmacy
NATIONAL UNIVERSITY OF SINGAPORE;
Principal Investigator
GEA-NUS PHARMACEUTICAL PROCESSING RESEARCH LABORATORY

14:15 The New Regulatory Paradigm: From The Industry’s Viewpoint

• The principles of GMP & regulation from a manufacturer’s point of view
• Understanding how to better manage regulatory agencies’ GMP enforcement guidelines for effi cient operational processes
• Success stories and best practices of achieving the right balance and interpretation of GMP compliance

Regina Yeo
Director of Quality, Asia Pacific
GLAXOSMITHKLINE

15:00 Process Analytical Technology- A Risk-Based Approach To GMP

Good Manufacturing Practices regulations address issues including recordkeeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation, and complaint handling. These regulations, which have the force of law, require that manufacturers, processors, and packagers of drugs, medical devices, some food, and blood take proactive steps to ensure that their products are safe, pure, and effective. GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mix ups, and errors. US courts may theoretically hold that a drug product is adulterated even if there is no specific regulatory requirement that was violated as long as the process was not performed according to industry standards.

PAT Initiative is designed to establish product quality regulations on sound science and engineering principles for assessing and mitigating risks of poor product and process quality in context of the intended use of pharmaceutical products. This presentation will take you through:

• Techniques to ensure product quality and performance is achieved by design of efficient manufacturing processes
• Product specifications based on mechanistic understanding of how formulation and process factors impact product performance
• Tips on how to effect continuous improvement and continuous “real time” assurance of quality
• Strategies on how to ensure time-to-market by real time release and higher quality by real time quality assurance
• How to achieve better process understanding by monitoring of critical attributes
• The regulatory policies and procedures that are risk-based and reflective of current scientific knowledge

Doug Rufino
Senior Director, Quality Control and Analytical Development
DSM PHARMACEUTICALS INC.

15:45 Achieving Targeted Drug Development From Botanical Sources

In 2004, The U.S. FDA released a document titled “Guidance for Industry: Botanical Drug Product.” There are currently over 150 investigational new drug applications under the botanical guidance for a variety of clinical indications. The majority of the applications are investigator initiated applications, while few companies are attempting botanical drug development. Although the history of drug development is replete with examples of drugs from botanical sources, with numerous best selling drugs coming from the plant world, the pharmaceutical industry has not invested significant resources in botanical drug development.

Some of the traditional issues and concerns the industry faces are the isolation of new chemical entities, the complexity of synthetic processes, manufacturing consistency of biological plant extracts and the identifi cation of molecular targets.

Bionovo Inc. focuses its targeted drug discovery and development approach on botanical agents used in traditional medicines. This presentation will focus on the manufacturing challenges facing the development of MF101, a selective estrogen receptor beta (ERβ) for the treatment of menopausal vasomotor symptoms.

• Botanical sources for GMP manufacturing: agriculture versus native, species identification and authentification
• Choosing a target, activity guided isolation and structure lucidation
• Extraction optimisation
• Tips on ensuring manufacturing consistency

Isaac Cohen
Chairman and CEO
BIONOVO INC.

16:45 How To Ensure That Your Team Is Always Ready For Audit Checks: An AstraZeneca Success Story

• Regulatory inspections- Why are they generally most feared?
• What goes into inspection preparations?
• Examining how to always document your processes effectively whilst still managing your product schedules and reputation
• Best practices on maintaining a well-ordered process so that your product cycles are not disrupted
• Understanding how to meet the expectations of auditors for high quality products and timely product launches

Premnath Shenoy
Regulatory Affairs Director
AstraZeneca India

17:30 Overcoming The Different Levels And Costs Of Regulations To Achieve A Competitive Edge With Proper Training For Employees

• Issues to consider when taking up a training programme for your company
• How to effectively implement a training plan for your team and ensure the GMP compliance message is translated into operational success across the team

Darren Freestone
Senior Consultant
SEERPHARMA (SINGAPORE) PTE LTD

18:00 Chairman’s Summary & Close Of Conference Day One

[ Register Now] · [ Next: Conference Day Two: Tuesday, 29 July 2008 ]