Drafting Commercial Contracts for the Pharmaceutical Industry

Management Forum
Course summary
3 days
1,799 GBP excl. VAT
Open / Scheduled
Next available date: 10/06/2020 - London
Course Dates
10/06/2020   (English)
1,799 GBP
18/11/2020   (English)
1,799 GBP

Drafting Commercial Contracts for the Pharmaceutical Industry

Course Overview

In such a highly regulated industry and in these turbulent and uncertain times, understanding the key challenges of negotiation and drafting an effective and watertight contract on an international level are complex topics. They can be difficult for even the most well-equipped in-house lawyer and most often it is not the lawyer in the driving seat. Commercial managers from all areas of the pharmaceutical industry are leading negotiations and drafting and managing key contracts on a daily basis. It is vital that both legal counsel and commercial executives not only have the key skills and tactics to create a win:win scenario but also the knowledge to ensure any agreement is within the laws and regulations. The alternative is the exposure of the organisation to unnecessary risk and costly disputes, especially with the complication of Brexit.

The programme consists of five modules which will:
  • Deliver an in-depth examination of intellectual property issues that affect pharmaceutical industry agreements
  • Focus on competition regulations pertinent to pharmaceutical industry agreements
  • Analyse the commercial and legal issues affecting pharmaceutical industry agreements
  • Examine collaboration and licensing agreements
  • Feature an in-depth workshop on effective negotiation skills

The delivery style
This unique and highly interactive three-day programme looks at all stages of the contracting process and aims to deliver applied training through a balanced blend of practical learning. The presenters will use a mixture of practical exercises and cases from the pharmaceutical industry to ensure you leave the seminar with the knowledge and skills to perfect all stages of the process.

Who Should Attend?

Personnel from R&D, clinical, regulatory, commercial, sales and marketing, manufacturing, distribution and purchasing functions, including:
  • In-house counsel
  • Commercial and contract managers
  • Business development managers
  • Purchasing and procurement
  • Heads of legal departments
  • Legal advisers
  • Patent, IP, trade marks or licensing counsel

The Key Objectives

By attending this seminar, you will:
  • Understand the key intellectual property issues affecting pharmaceutical industry agreements
  • Find out about the implications of SPCs for pharmaceutical industry agreements
  • Explore the current issues relating to IP including the Unified Patent Court and the challenges of Brexit
  • Learn how to draft contracts to avoid anti-trust infringement
  • Familiarise yourself with the key commercial and legal issues that affect pharmaceutical industry agreements
  • Gain knowledge of the key issues in clinical trial agreements, contract manufacturing agreements and co-promotion, co-marketing and distribution agreements
  • Update your practical skills when drafting effective collaboration agreements
  • Get to grips with the competitive nature of doing deals in the pharmaceutical industry and the tactics for effective and successful negotiation

Programme At A Glance

MODULE 1: Intellectual property issues relevant to pharmaceutical industry agreements
  • PRACTICAL WORKSHOP: Intellectual property terms in collaboration and licensing agreements
  • Current key issues relating to IP in the pharma industry
  • Supplementary protection certificates (SPCs) – securing the full commercial potential of your product
  • When does R&D infringe patents? Understanding experimental use and Bolar provisions
  • Third-party IP rights – freedomto- operate searches and implications for pharmaceutical industry agreements
MODULE 2: Key pharmaceutical industry commercial agreements and legal and regulatory issues related to their drafting
  • Key issues in contract manufacturing agreements
  • Key issues in co-promotion, co-marketing and distribution agreements
  • Medicines regulations using regulatory processes to define contractual obligations
  • Key issues in clinical trials and related agreements
MODULE 3: Workshop on collaboration and R&D agreements
  • Negotiating and drafting collaboration and licence agreements – a practical workshop
MODULE 4: Competition law workshop
  • Introduction to relevant EU competition law rules
MODULE 5: Negotiation skills in the pharma sector
  • The rise and rise of the negotiator
    • Negotiate and succeed
    • Structure for control
  • Personal style and negotiation
    • Moving into engagement
    • Influencing and persuasion

Provider: Management Forum

Management Forum

Management Forum - Professional training courses for the Life Sciences and Intellectual Property Sectors

Management Forum is an internationally renowned training provider organising professional conferences, seminars and in-house courses for professionals and companies in the Life Sciences and Intellectual Property sectors. With their growing programme portfolio, training specialists at Management Forum aim to provide...

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Reviews by course attendees

Average rating 4.6

Based on 9 reviews

High quality content and course materials. Professional presentation within a relaxed learning environment. Fantastic speakers who were happy to answer questions during their talks and the breaks.
Insightful teachers, great take-home material, stupendous learning environment.
Very useful course. I'm sure it will be useful for my future career
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