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Interim Company Compliance Officer support
Steven Gray is available for short to medium term interim management assignments
Initiating and responding to Code breach allegations
Release your in-house resource from the time-consuming investigations and letters that are involved in inter-company dialogue or communication with the PMCPA. We can undertake the majority of the work on your behalf. Compliance investigations
Mistakes happen. However you need to differentiate between mistakes, negligence and deliberate disobedience. We offer discrete independent assessment of alleged breaches. Independent assessment of sponsorship and grant applications
Maintain the distance between the support you offer your customers and any potential allegations of inducement. Let us review sponsorship applications on your behalf. Auditing services
You need to know when things aren't working. We offer a wide range of services to help uncover your compliance risks, from reviewing your policies to scrutiny of materials and in-field activities. Design & development of compliance reports & policies There are certain key policies and procedures that are required as a condition of membership of the ABPI: - Certification of promotional (and non-promotional) material
- Certification of representative's training and briefing material
- Approval and payment of representatve's expenses
- Meetings & Hospitality arrangements and expenses
- Representative's Training
- Non-interventional Studies of Marketed medicines
- Provision of medicines and samples
- The use of consultants
- Medical and Educational Goods and Services (including promotional aids and donations)
- Relations with public and the media
- Relationships with PatientOrganisations
- The Internet
- Breaches of the Code and withdrawal of in-breach material
- Co-promotion (where applicable)
In addition, there are a number of areas where experience strongly suggests that written guidance can help avoid compliance breaches and save companies valuable time in the development of material. We provide a comprehensive range of template policies. Most policies are written in a very formal way, yet front-line staff are typically hands-on practical people. Our consultants can help deliver policies that are robust without being onerous to read. We can help with Governance frameworks, policy development and compliance reporting. We can also support the roll-out of policies and frameworks to your staff in an engaging and effective manner. Our partnership with leading creative agencies also enables us to provide some very innovative approaches to the roll-out! We believe there are fundamental differences between formal SOPs, process controls and general guidance policies. We can help you identify what document is appropriate for your needs at the time and support you in the development and the roll-out. We also have a range of template policies that can be adapted for use by individual companies. Return to top
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Audit & Consultancy