Programme Goals
This workshop will take you on an in-depth compliance journey through the ‘client/agency’ relationship from contract to audit. It will also examine the ways in which you can anticipate and manage changes that will affect compliance requirements.
Our goal
Our
goal is to help you build and extend your compliance knowledge and
provide an opportunity to share practices and problems with fellow
professionals.
Who is the workshop for?
- Those with a responsibility for compliance within their organisations
- Those who already have knowledge of the BHBIA’s Legal and Ethical Guidelines and the ABPI/BHBIA Guidelines for Adverse Event Reporting.
The day
Guest speakers and compliance experts will cover key considerations at all stages of a market research project from initiation and contracting to completion and delivery, so that you can make sure that your organisation meets the highest compliance standards.
This will be a practical and interactive day, there will be plenty of opportunities to discuss your issues with our experts and your peers. We will rely heavily on real life examples and case studies.
The programme
The day will be made up of three key sessions:
- Setting Up - We will start with how to set in place the foundation stones of your compliance relationships, internal and external – beginning with your compliance culture and moving on to setting up the compliance terms in a contract.
- Keeping Up - Keeping up with key compliance needs during the course of a market research project – moving through key project stages and their compliance demands to an audit of compliance.
- Looking Up - Looking to the future and adapting to changes in relationships, tools, data, regulations and laws – finally, we examine some of the changes we face and how to manage these.
Each session will feature an opportunity to ‘Ask the
experts’ - time for you to ask questions about issues that are
important to you.
Compliance by Design - The Programme - in more detail
Setting Up
Setting in place the compliance foundation stones of the relationship, we will talk about
- Building a compliance culture within your organisation and working across functions
- Building and negotiating the contract:
- What to look for and what to ask for
- Who should provide what reference materials (SOPs, AER forms, training certificates) and contacts
- Making the relationship two way and setting expectations
Keeping Up
How to keep up with key compliance needs during the course of a market research project:
- The grounds for data processing:
- Consent vs legitimate interests
- Consent agreements and privacy notices
- ABPI Code of Practice requirements
- Managing AE reporting - timescales, QC and reconciliation requirements
- Record keeping, storage and transfer
- Training, including training logs and certification records
- Navigating an audit – internal and external:
- What to expect and what to prepare
- Remaining in control and handling the highs and lows
Generating engagement:
- Motivating your colleagues and partners to engage with compliance
Looking Up
Looking to the future and adapting to changes in relationships and in the environment.
- Changing relationships:
- Communication channels and communicating effectively
- Challenging relationships – internal and external
- Changing tools:
- New methods and new data sources
- Changing regulations and laws:
- Preparing for the GDPR