March 27-28, 2012 - Montréal, Canada

This course provides a comprehensive review of Clinical Trials (Phases 0-4) and ICH Good Clinical Practices (ICH GCP) and FDA regulations and requirements. Participants receive a foundation of knowledge about clinical trials, ICH GCP and FDA and the underlying scientific and regulatory principles involved. Guidance on each aspect of research is provided, as well as information on the structuring and preparation of protocols, consent forms and investigator brochure. Information on maintaining an ongoing relationship with FDA will also be discussed. This course enables clinical, regulatory and research professionals to prepare concise documents and provide their company and FDA with the necessary information for their clinical trials.

The Presentation will cover

• Learn about Clinical Trial Phases 0 - 4
• Understand rationale for doing certain studies in each phase
• Learn criteria for pivotal trial studies
• Which studies are used for supporting data and which studies are deemed pivotal trials
• Learn about the ICH GCP; the global GCP
• Learn how ICH GCP impacts the clinical trial process
• Learn how to prepare clinical documentation
• How to maintain an ongoing relationship with FDA

March 7-8, 2012, March 27-29, 2012 - Toronto, Canada

Day 1 - Wednesday March 7, 2012 
Finance for the Non-Financial Executive

Day 2 - Thursday March 8, 2012 
Foundations of Project Management

Day 3 - Tuesday March 27, 2012 
Strategic Planning

Day 4 - Wednesday March 28, 2012 
Balanced Scorecard and Presentation Skills for Leaders

Day 5 - Thursday March 29, 2012 
Marketing Management for Leaders

March 18-20, 2012 - Cairo, Egypt

The guidance on marketing applications for drugs and biologics, known as the Common Technical Document (CTD), was finalized by the International Conference on Harmonization (ICH) in 2003. Today the CTD format is mandatory for paper-based marketing applications in Europe, Japan, Canada, and other regions, and is highly recommended by FDA.

The eCTD format has become mandatory in key regions for electronic submissions. Since January 2010, the European Medicines Agency has required all applications in the centralized procedure use the eCTD format.

This three-day course is designed to identify and review applicable regulatory guidelines (EU, ICH, and other regional guidances), providing information on the content and preparation of the CTD, and will address specifications and granularity for electronic submissions (eCTD).

The course discusses tips for efficient preparation of the CTD with submission-ready reports that can be written early in development and inserted or expanded for marketing applications. The use of CTD mapping and templates to facilitate gap analysis, project management, CMC strategy, and life cycle management will also be addressed in interactive workshop sessions. Case studies will be presented throughout the course to encourage discussions.

Upon completing this program, participants will have a sound understanding of how to plan and prepare all sections of a marketing application in the CTD (Common Technical Document) format per ICH guidance (including starting at the development stage with knowledge of the ICH and relevant regional guidances). Participants will also learn tips on how to plan, author, review, and format CTD and eCTD submissions effectively and efficiently, as well as, how to work with submission teams in a classic or virtual development setting.

In Completion of successful training, attendees will be given certificate of achievement from the Academy of Applied Pharmaceutical Sciences (AAPPS) (IPA’s sister organization). Academy of Applied Pharmaceutical Sciences (AAPS) is licensed by the Ministry of University and Colleges of Ontario, Canada. (Please visit www.aaps.ca)

March 6-7, 2012 - New Jersey, USA

This two-day, interactive program will focus on the following topics through discussion, case studies and workshops:

• History of FDA Regulations
• Management Responsibility
• Quality Audit
• Personnel
• Design Control
• Document Control
• Purchasing Controls
• Identification and Traceability
• Production and Process Controls
• Inspection, Measuring, and Test Equipment
• Process Validation
• Acceptance Activities
• Nonconforming Product
• Corrective and Preventive Action
• Labeling and Packaging Control
• Handling, Storage, Distribution and Installation
• Records
• Complaint Handling
• Servicing
• Statistical Techniques
• What to Expect During an FDA Inspection

April 24-26, 2012 - Orlando, Florida

• What are Health Canadian, US, and European guidelines for temperature control of drug products during storage and transportation?
• Cold Chain Transportation & Storage of Vaccines
• The Last Mile:
• Ensuring Cold Chain Integrity all the Way through to the Consumer or Health Care Provider
• Difference between "Monitoring" and "Controlling" Temperature:
• How Do You Control the Temperature of your Cool Chain Shipments in an Airfreight Transport Environment?
• Process Analytical Technology in Cold Chain
• Complyingand Applying USP <1079> "Good Storage and Shipping Practices"
• Methods and Solutions that Companies can use to Reduce their Costs in Cold Chain
• Using Risk Management Tools to Manage the Integrity of the Cold Chain
• Implementing Cold Chain Controls from Manufacturing to Distribution for Cold Chain Pharmaceutical Products
• Temperature Monitoring During Warehousing and Transportation
• International Focus: Import/Export Shipping Challenges and Best Practices
• Regulatory Update: Developments in Good Distribution Practice Regulations and the Impact on Clinical Supplies
• Cargo and Asset Management along the Cold Chain
• Advances in Container Refrigeration Technology
• Improving the Performance of Transport Assets & Cold Chain Infrastructure
• Best Practices in Pharmaceutical Cold Chain Management
• Cold Chain Challenges in a Continental-Sized Country: How to Face an Increased Demand Scenario
• Cold-Chain Logistics in Healthcare: A Modern Alternative Environment and Application Problem
• Evaluating an Inspector’s Perspective on Common Mistakes in Cold Chain Handling
• Definition of a Quality System for Temperature Controlled Pharmaceutical Distribution
• Air Cargo Transportation in the Temperature-Sensitive Healthcare Sector
• Minimizing Vaccine Damage During Distribution: A WHO Guideline
• Overcoming the Latest Pharmaceutical Cold Chain Management Challenges
• Evaluating Specific Challenges and Solutions in the Biopharma Cold Chain
• Identifying Innovative Solution for Airfreight Transportation in the Cool Chain
• Addressing Risks in Global Frozen Shipments of Biologics and Pharmaceutical Products
• Future Challenges of the Biopharma Cold Chain
• Ensuring Integrity of Products through Transportation
• Materials Used in your Sterile Barrier System for Shelf-Life Products
• Carbon Footprint: Methods and Solutions

WORKSHOPS:

• Developing a Compliant and Reliable End-To-End (E2E) Temperature Monitor Management Program (Mr. Jeffrey James, Merck)
• Air Cargo Transportation in the Temperature-Sensitive Healthcare Sector (Dr. Christelle Laot, FedEx)