Effective Compliance with Good Marketing Practice in the Pharma Industry

This unique two-day In-house workshop will give you key insights into how the global, regional and national codes of practice work together to form a framework for compliance.

Course Overview

This unique two-day In-house workshop will give you key insights into how the global, regional and national codes of practice work together to form a framework for compliance. Good marketing practices will enable you to ensure both yourself, and your organisation, are compliant on a national and global level.

Why you should attend this programme?

During this two-day highly experiential programme you will:
  • Review the various codes, scope and enforcement
  • Understand where there is overlap between industry codes and jurisdictional law
  • Examine the scope of interactions with Health Care Professionals for scientific discussion of medicines
  • Evaluate the regulations pertaining to marketing authorisations and off-label marketing
  • Appraise the sponsorship and engagement of Health Care Professionals
  • Understand the considerations for working with third parties
  • Access any code changes that may have an immediate impact on you current practices

Who should attend?

  • Compliance officers
  • Commercial and contracts managers
  • Business development managers
  • Marketing and sales managers
  • Nominated signatories

Sample Programme Day 1

Introduction to the various codes, their scope and enforcement
  • Definitions
  • Penalties from recent cases
Overlaps between industry codes and national/international laws
  • Foreign Corrupt Practices Act (USA)
  • UK Bribery Act
  • Penalties from recent cases
Interactions with Health Care Professionals for scientific discussion of medicines
  • Hospitality
  • Samples
  • Information provided
  • Items of medical utility
  • Cultural courtesy gifts

WORKSHOP SESSION ONE – A scientific discussion of medicines
Participants will analyse a scientific discussion to be held over three days in Vienna with a full speaker agenda and gala dinner.

Marketing authorisations and off-label marketing
  • Scientific discussion of clinical trial results and off-label uses

WORKSHOP SESSION 2 – A scientific discussion of medicines
A practical workshop sessions examining a scientific discussion of the data gathered during a clinical trial.

Sponsorship of Health Care Professionals
  • Attending scientific conferences
  • Other events for Continuing Medical Education
  • Considerations for travel, accommodation and hospitality

WORKSHOP SESSION 3 – Sponsorship of events organised by third parties
Participants will analyse a global conference organised by a third party.

Engagement of Health Care Professionals
  • Consultants, advisors, speakers, authors
  • Fees for service
  • Independence
  • Conflict of interest
  • Transparency considerations

WORKSHOP SESSION 4
Participants will pull together the threads of case studies 1, 2 and 3.

Sample Programme Day 2

Grants and donations
  • Health centres
  • GP practices
  • Hospitals
  • Medical charities, etc.

WORKSHOP SESSION 5 – A proposed donation to a church in South Korea
Participants will develop patient education programmes, disease awareness campaigns, patient audits, non-interventional studies and patient support programmes.

WORKSHOP SESSION 6 – Patient audit
Participants will work on a patient audit of patients with respiratory problems, alongside a patient education programme.

Interactions with patient groups
• Transparency considerations

WORKSHOP SESSION 7 – Funding
Participants will look at funding for a patient group that actively campaigns for specific treatments.

Considerations for third parties
• Event organisers
• Contract sales organisations
• Contract research organisations
• Market researchers, etc.

WORKSHOP SESSION 8 – Due diligence
Participants will review due diligence and practical considerations prior to signing contracts with an event organiser.

Potential code changes
• Considerations to enable current activities to withstand future scrutiny

WORKSHOP SESSION 9 – Pulling it all together

Recommended Trainer

Sue Egan BSc, MBA, FCMI is a Cranfield MBA who is an enthusiastic, approachable and supportive tutor with a proven track record in pharmaceutical compliance. She uses a blend of theory and case studies to emphasise key learning points, using plain language with as little jargon as possible. Sue has been a Compliance Officer at all levels from single marketing company to international VP for GlaxoSmithKline and AstraZeneca, where she gained more than 8 years of practical experience and a reputation for a pragmatic approach. She is a founder member of the organising committee of the International Pharmaceutical Compliance Forum conferences. She has a high reputation as a speaker and presenter of case studies at these conferences, both in the USA and Europe.

Continuing professional development

This course qualifies for the following CPD programmes:

  • Certificate

Bespoke training

We can customise this course to meet the requirements of your organisation. Contact us to discuss your training requirements.

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