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05-12-2018 (Singapore)

P40085 Contract Manufacturing Agreements
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Contract Manufacturing Agreements

5 – 6 December 2018 | Mandarin Orchard Hotel, Singapore

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Team Savings: Register 2 Delegates & the 3rd Comes free!

overview

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

  • Anyone responsible for Contract Manufacturing Agreements
  • VP, Director, Heads, Managers of: Manufacturing
    • Quality
    • Process Engineers
    • Technical and Operations
    • Legal
    • General Counsel
    • GMP compliance
    • GMP quality systems

What past participants say about our Pharma courses

“Exercises were useful and trainer is knowledgeable”
~ Noor Aida Binti Jaafar, Head of Marketing & Specialty Care, CCM Pharmaceutical

“Case Studies and the workshop activities really helped a lot and more practical”
~ Praveen Kumar, Senior Manager, Pharmaniaga

“Informative & insightful. Had a chance to network and share discussion / cross learn from participants”
~ Chng Kien Peng, Executive Director, Xepa-Soul Pattinson (S) Pte Ltd

“The course is very relevant to my job. The case studies and the workshop activities really helped a lot and were practical.”
~ Avadhanula Yagna Praveen Kumar, Senior Manager Intellectual Property, Pharmaniaga BHD

“Very informative. It covers all scopes under the topics”
~ Norliza Binti Abdullah Zawawi, Legal Assistant Manager, Pharmaniaga Berhad

pricing

Packages Price
2 Day TrainingSGD $3495Early Bird

Early Bird Rate: Register and Pay on or before 28 September 2018

Register 2 Delegates & the 3rd attends FREE!
Group rate is based on normal rate of 2-day main conference package only.
For Group Registrations, email register@ibcasia.com.sg or call +65 6508 2401

 

  • Special Group Discount pricing is applicable to groups of 2 or more delegates from the same organisation registering for the same event, at the same time.
  • Fee stated is the discounted price PER DELEGATE. Only one discount applies – either the early bird rate OR the Special Group Discount.
  • All fees stated include luncheons, refreshments and complete set of documentation. It does not include the cost of accommodation and travel.
  • A 7% Goods & Services Tax (GST) is applicable to all Singapore based companies for Singapore venue.

trainer

DI Dr. Salma Michor A Practical Guide to Pharmacovigilance & Contract Manufacturing Agreements

DI Dr. Salma Michor

MBA, RAC, CMgr, FCMI

Agenda

DAY ONE

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

CASE STUDY – 1

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

CASE STUDY – 2

DAY TWO

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

CASE STUDY – 3

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)

CASE STUDY – 4

when & where

05 - 06 Dec 2018

Mandarin Orchard Singapore, by Meritus
333 Orchard Road, Singapore 238867
Tel: +65 6831 6062 | Fax: +65 6737 3130
Mobile No.: +65 8298 9442
Contact Person: Tan Ai Li
Email: aili.tan@meritushotels.com
Website: www.meritushotels.com

On-site & in-house training

Deliver this course how you want, where you want, when you want – and save up to 40%! 8+ employees seeking training on the same topic?

Talk to us about an on-site/in-house & customised solution.

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