Effective Compliance with Good Marketing Practice in the Pharma Industry

All commercial, sales and marketing professionals are aware of the importance of precise communication and reliable and objective information on medicinal products. A poor understanding of the rules and regulations that apply when promoting a product nationally and internationally will heavily impact rational decision-making and can lead to costly dispute and ultimately product failure.

It is vital that all commercial professionals working within this highly regulated environment understand where they are exposed to risk and how to remain compliant at all times.

This unique two-day 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

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.

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

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.

Finance for Non-financial Managers in the Pharma Industry

Drafting Commercial Contracts for the Pharmaceutical Industry

Understanding the Pharmaceutical Industry

The Pharma 'Mini-MBA' On-line Learning Programme

This course qualifies for the following CPD programmes:

• Cert: 0.00 hours