Ethics and Compliance
Embedding Compliance into the Organisation
Given the complex legal and regulatory landscape of the life science, pharmaceutical, medical device, and healthcare sectors, there is a real need to cultivate a culture of compliance, which is supporting having and demonstrating that robust processes are in place to ensure compliance with codes and regulations.
It is important that businesses have an appropriate compliance program in place to ensure personnel are sufficiently trained, stakeholders understand and believe that a culture of compliance will simplify their roles, and materials are appropriately used and approved. Interactions with third parties, transfers of value, and anti-corruption measures are aligned with Industry standards.
Life Science Law can support you in devising and implementing a proportionate compliance management system which will drive business productivity.
Prevent
Guidelines, Policies and Training is needed to ensure a streamlined approach.
Code of Conduct
Sets the tone which flows through the company
Policies
Clear guidelines to provide the organization with confidence in what they are doing
Training
Regular training on internal processes aligned with role
Third Party Due Diligence
Ensuring the ethos of external partners is known
Communication
Regular channels of communication which reinforces the ethos
Detect
Monitor, measure, analyse, evaluate. Controls must be in place to manage identified risks and associated compliance processes.
Risk Assessment
To identify areas of risk and evaluate gaps and improvements
Monitor
Continual monitoring to ensure adherence to process
Audit
Independent audits are an effective tool to uncover gaps
Investigate
A consistent, objective and documented investigation process
Whistleblower
A channel is needed where concerns can be anonymously reported
Respond
A fair and consistent process is required to address gaps proportionately.
Case Management
A documented streamlined process to ensure fairness
Objective Actions
Outcomes are uniform and fair
Training
To close an identified knowledge gap
Risk Mitigation
Putting plans in place to mitigate identified risks
Improvements
Implementing strategies to close identified gaps
A culture of compliance is a journey not a destination
A culture of compliance can only be built with ownership of compliance being viewed as every-one’s responsibility, from the top down. It will involve putting strategies and measures in place that seek to embed compliance within every area of the organisation, and so it starts with the tone at the top, which must be cascaded down. Compliance is not the responsibility of the Compliance Team alone.
A Wealth of Experience Ensuring Ethics and Compliance
We have a strong team of anti-corruption and industry compliance experts who have worked in-house, and successfully developed a culture of compliance. We have a great wealth of experience in developing and maintaining robust internal compliance programs.
Ethics and Compliance Case Studies
Below we have listed some of the areas of ethics and compliance support we have provided to our clients:
- Undertaking a Risk Assessment of the Business to identify gaps.
- Developing Health Care Professional (HCP, HCO) Contract Templates
- Developing and documenting the Medical, Legal, Review Processes (MLR)
- Training on external Regulations and Internal Processes
- Developing processes to handle payments to third parties,
- Transparency Reporting Processes & Fair Market Value
- Development of Integrity & Whistleblowing hotlines
- Supporting the development of investigation programmes.
- Drafting Standard Operating Procedures & Training
- Anti-corruption Process Development & Training
- SOP Training & Development
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Discuss Your Challenges with One of Our Experts
We are ready to discuss your challenges and would be delighted to help you identify an optimal solution, and a practical course of action to get you there.
Contact us today.