The challenging role of compliance management in the pharmaceutical industry

The Pharmaceutical organizations need to be mindful of patient safety issues so that the failures don’t jeopardize the future of the entire enterprise. Therefore, identifying, analyzing and mitigating compliance risks are essential in developing an effective compliance programme and ensuring the future sustainability of the industry. 

The risks in compliance failure 

The cost of litigation is huge. Legal and compliance failures can cause serious reputational and financial damage to pharmaceutical companies.There are many regulators and enforcement agencies like the Medicines and Healthcare products Regulatory Agency in the UK, the European Agency for  Evaluation of Medicinal Products, and the FDA in the US, that are increasing pressure and making regulation tighter day by day.

Embedding compliance policies in enterprises

Organizations planning to enhance compliance must follow industry best practices and offer the most innovative products in order to stay ahead of the competition and meet customer requirements.The frequency of monitoring and reporting on the KPIs will depend on whether they are event-driven, such as when a new regulation has come into effect, or whether they provide insights into the way the organization is functioning.

Compliance initiatives can be the key to long-term efficiencies

The pharmaceutical industry will continue to face unprecedented challenges amid the increasing regulatory scrutiny.Globalisation, partnerships, transparency expectations, emphasis on innovative technologies and the ever-evolving needs of existing and emerging customers are driving companies to renew their approach to compliance. So a conservative approach to compliance will not be sufficient for the future sustainability of the industry.

The compliance skill set is changing and mature compliance functions have implemented initiatives to develop talent. Companies can be successful only when they are able to sustain their compliance talent pipeline to meet the increasing demand and changing nature of compliance skills.