Contract Manufacturing Agreements | Michor Consulting
Dates:
Dec 05-06
Book now

A 2-day practical & interactive training:

Contract Manufacturing
Agreements

This two-day workshop focuses on the three prerequisites that are needed to work out contracts which are legally and GMP compliant.

Key Learning Outcomes

This workshop focuses on the three prerequisites that are needed to work out contracts which are legally and GMP compliant:
  • Awareness of the GMP requirements
  • Applicable legal and juristic knowledge
  • The practical perspective
Matters which delegates will gain a detailed understanding of include:
  • GMP Requirements of the Regulatory Authority
  • A Legal Perspective on Agreements
  • Best Practice Design and Layout of Contracts
  • Basic Juristic Knowledge for Responsible Functions under International Law
  • Pharmaceutical Contracts and Inspections
  • The GMP Technical Agreement / Quality Agreement
  • Responsibilities on Mutually Agreed Specifications
  • Supply and Service Agreements

Who should attend

  • CEOs, Directors, Heads of Departments, Managers of:
    • Clinical Outsourcing and Clinical Operations
    • Project and Contract Management
    • Finance/Purchasing/Project Controlling
    • Procurement/Purchasing
    • Strategic Sourcing
    • Programme/Portfolio Management

Agenda

DAY 1
9am - 5pm
GMP REQUIREMENTS OF THE REGULATORY AUTHORITY
  • Outsourcing of activities
  • Which external activities require Technical/Quality Agreements
  • Regulatory requirements
  • Best practice how to create a Technical/Quality Agreement
AGREEMENTS – THE LEGAL PERSPECTIVE
  • Confidentiality agreement or Non- Disclosure Agreement
  • Technical/Quality/Supply Agreements
  • Other Agreements
  • Their structure and how they fit together within the GMP system
BEST PRACTICE DESIGN AND LAYOUT OF CONTRACTS
  • Basic principles – contractual obligations and responsibilities towards third parties
  • Contents of agreements and how to evaluate them
  • Definitions/Timelines and Targets
  • Loss of Products/Intellectual Property
  • Assignment Term and Termination
  • Arbitration
INTERNATIONAL LAW: BASIC JURISTIC KNOWLEDGE FOR RESPONSIBLE FUNCTIONS
  • International laws and systems – how they work and fit together
  • Jurisdictions and conflict of law provisions
  • Contract law/Jurisdictions law
  • General product liability concepts
DAY 2
9am - 5pm
PHARMACEUTICAL CONTRACTS AND INSPECTIONS
  • Business contract vs. Technical/Quality Agreement
  • Clear responsibilities
  • Product life cycle and Technical/Quality Agreement
  • Internal contracts
  • Frequent findings
THE GMP TECHNICAL AGREEMENT / QUALITY AGREEMENT
  • Who is involved
  • Terms and arrangements
  • Demands and challenges
  • Quality agreements during the life of a project
  • Economic limits
RESPONSIBILITIES AND THE MUTUALLY AGREED SPECIFICATIONS
  • Who is responsible for what
  • Who is involved
  • Helpful terms and arrangements
  • Supervision of agreed responsibilities
  • Implementation of contractual obligations into a company’s GMP system
SUPPLY AND SERVICE AGREEMENTS
  • Practical aspects to consider when establishing robust contracts
  • Suppliers of excipients, packaging materials and other components
  • Service providers (e.g. clothing, pest control)
Very Hands-On and Interactive:
  • Hands on case study –What should be included in a technical agreement
  • Case study – Handling contracts across regions
  • Interactive evaluation of technical agreements
  • Case study to explore responsibility – who is responsible for what
This course is a cooperation with IBC Asia - Singapore’s leading conference, exhibition and training company.
EARLY BIRD RATE: Register and Pay on or before 29 September 2018:
SGD 3.295 (SAVE SGD 200) / EUR 2.063,99 / USD 2.420,11
NORMAL RATE: Register and Pay after 29 September 2018:
SGD 3.495 / EUR 2.189,27 / USD 2.567,01
Book this training
Book now (PDF with booking formular)
For further questions please contact us:
Michor Consulting: +43 (0)1 890 57 14 | office@michor-consulting.eu
IBC Asia: +65 6508 2401 | register@ibcasia.com.sg
A cooperation with: