8:30 Welcome Address And Chairperson’s Opening Remarks

Rafik H. Bishara
PhD, Technical Advisor, Chair, Pharmaceutical Cold Chain Interest Group (PCCIG)
Parenteral Drug Association (PDA)

8:45 Complying With Health Canada Guidelines For Temperature Control During Storage And Transportation - GUI-0069 (Version 2)

• Overview of the revised GUI-0069 and GMPs related to temperature control
• Discussing the new requirements in the 2009 revision of GUI-0069
• Understanding requirements for wholesaling, storage and shipping
• Packaging, labeling, documentation, and record keeping requirements
• Sample observations and corrective action expectations
• Common questions from Industry on the topic of GUI-0069

Sarah Skuce
Compliance Specialist
Health Canada

9:30 Complying And Applying USP <1079> “Good Storage And Shipping Practices”

• Understanding the role of the USP within the industry and the latest information regarding standards
• Outlining the new 1079 chapters for implementation
• Understanding 1079’s definition for validation (for packaging) and comparing to other industry standard guidelines
• Packaging, storage and distribution
• Container processes and requirements
• Overview of evidence gathered
• Uncovering new guidelines

Mary Foster
PhD, USP Packaging and Storage Expert Committee Member
US Pharmacopeia (USP)

11:00 European Regulatory Guidelines: Controlled Or Ambient Temperatures, Stability Data And Compliance

• Expectations and documenting for ambient or CRT products
• Regulatory expectations for qualification or validation
• Stability studies versus shipping studies – Are stability studies enough to set the limits for your cold chain?

Ian Holloway
Manager, Defective Medicines Report Centre
Medicines and Healthcare Products Regulatory Agency (MHRA)

11:45 Panel Discussion: Understanding Current And Future Regulatory Expectations For Cold Chain, Both Domestically And Internationally

• Lessons learned in justifying Pharma company actions and validation plans to regulators – What exactly demonstrates control?
• New regulations on storage, handling and distribution of drug samples & mail-order drugs
• Extrapolating future regulatory requirements in-line with cold chain trends
• Discussing global regulatory concerns and impending international changes

Moderator:

Rafik H. Bishara PhD
Technical Advisor, Chair, Pharmaceutical Cold
Chain Interest Group (PCCIG) Parenteral Drug Association (PDA)

Panelists:

1:30 Risk Managed Approach To Good Cold Chain Management

• Elements of a good cold chain management program
• Risk assessment and gap identification within the cold chain
• 3PL Service Provider Selection
• Importance of developing detailed shipping, handling and storage SOPs
• Master Service Agreements / Service Level Agreements
• Transportation Management Program (performance monitoring and grading metrics)
• Effective shipment tracking techniques
• In-transit and security best practices

Eric A. Newman
Vice President, Loss Prevention, ProTecht Risk Solutions
Falvey Cargo Underwriting

2:15 Seven Deadly Myths - The Rights and Wrongs on Cold Chain Distribution Management

• Understanding some common misunderstandings, assumptions, traditions and beliefs in Cold Chain distribution
• Challenging the traditions and wrong assumptions
• Fundamentally re-thinking /re-designing the Cold Chain distribution practice/process
• Examining future directions for core processes within your cold chain

Moderator:

Sherman Cheung
Director of Supply Chain Management
Sanofi Pasteur

Panelists:

3:45 Panel Discussion: Best Practices Ror Streamlining Clearance Of Temperature Sensitive Pharmaceuticals For Canadian Customs And Transport

• Understanding some common misunderstandings, assumptions, traditions and beliefs in cold-chain distribution
• Challenging the traditions and wrong assumptions
• Re-thinking/re-designing cold-chain distribution practice/process
• Identifying strategies for overcoming shipping impediments and inefficiencies at Canadian/US boarder crossings
• Understanding what is in store for future overland Canadian border crossing cold chain operations

Moderator:

Rafik H. Bishara, PhD
Technical Advisor, Chair, Pharmaceutical Cold Chain Interest Group (PCCIG)
Parenteral Drug Association (PDA)

Panelists:

Mau'veen Dayrell-Johnson
Senior Officer, Trade Compliance, Canada Border Services Agency (CBSA) Invited: A Representative of US Customs and Border Protection (CBP)
Department of Homeland Security

4:30 Interactive Global Distribution And Storage Strategies Roundtable Discussions

After a full day of presentations, it’s time for all participants to take an active role and get answers to specific questions. These informal discussions will provide an opportunity to exchange ideas related specifically to job functions and interests. Facilitators will present a short case study as an introduction to these 45 minute discussion and question sessions. Round Table Discussions include:

• Global regulatory approach to temperature compliance for cold chain and temperate products
• Implementing a validation lifecycle program for shipping temperature control pharmaceuticals
• Developing new shipping and validation processes for strict 2-8° biopharm products
• Best practices for data management associated with distribution of temperature-sensitive clinical trial materials
• PCCIG ‘Last Mile’ guidance document: implementing processes and standards to ensure temperature control to the patient Strengthening Cold Chain Vendor Relations

5:15 Effective Management Of Third Party Relationships

• Conducting needs assessment – With stake holder engagement
• Alignment of requirements with service offering
• Using a team approach for criteria of vendor selection and ranking
• Validating and assessing various decision criteria
• Maximizing the Relationship
• Using KPIs for targets and rating of performance
• Discussing continuous improvement initiatives

Gloria Markiewicz
Associate Director, Supply Chain
Novo Nordisk Canada Inc

6:00 Chairperson’s Closing Remarks And End Of Day One