Compliance on HCP/O interaction
Setup and training of organizations, systems and SOP’s to embed compliance management within your organization.
Maintaining regulatory compliance is of vital importance for companies operating in this highly regulated industry, and failure to comply can have serious consequences. However, keeping up with compliance requirements can be challenging. Adequate documentation that proves to regulatory bodies that all necessary precautions have been taken to ensure workplace compliance is an absolute necessity.
Companies in the biotechnology and pharmaceutical industry must make sure that products meet the safety standards set by regulatory bodies. The same holds true for interactions with HCP/O’s, in addition to which quality must be safeguarded at all times. To achieve a higher quality standard across the organization, employees must be trained on how to communicate and perform specific tasks relating to regulatory compliance.
Comprehensive compliance training from the outset of an employee’s career will aid in maintaining regulatory compliance across the organization. To adapt to changing market developments and requirements, learning systems should be updated continuously to include changes in industry compliance regulation.
A good training program will not only ensure that regulations are strictly adhered to but will also make sure that your company’s reputation is protected.
Compliance alignment audit – showing the GAP’s in your organization, systems and processes
GCO is fully aware and has in-depth knowledge of all aspects related to the pharmaceutical compliance guidelines and is able to advise and support clients with implementation processes and technology to ensure accurate and timely reporting on relevant spend related to interactions with HCP’s.
GCO has developed a comprehensive alignment audit model to identify the potential risks your company may encounter in interacting with HCP/O’s and how well your organization is capable of managing and mitigating these risks.
A compliance alignment audit forms an excellent basis to identify potential risks and training needs.
Compliance oversight – Certification and proving alignment of your Compliance organization
In the Pharma and Life Sciences industry, compliance can be based on laws and/or self-regulation. Self-regulatory bodies can shape industry standards, but cannot guarantee compliance oversight as long as there are no legal sanctions in place. Compliance oversight is a crucial strategic link in corporate policy, which may be addressed from two different points of view: Compliance can either be enforced internally through an ethics / compliance board, or through independent accreditation. In lieu of an independent accreditation body, GCO Consultancy will continue to pioneer in compliance oversight, by underlining the relevance and encouraging the acceptance of strict industry guidelines.
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