BMI SYSTEM participated in the 16th Pharmaceutical Regulatory and Compliance Congress took place in Washington DC from 21st – 23rd October 2015, one of the largest pharmaceutical events globally with over three hundred and fifty companies gathered to discuss topics around international compliance.
Compliance as a Central Concern
The event featured presentations by leading government regulators, company compliance professionals, in-house counsel, prominent industry consultants and legal counsel:
- Recent developments in the debate over off-label communications and the first amendment
- Update from CMS on open payments
- Consolidation, vertical integration and cross-border business
- The future of ethics and compliance programs
- Managing multi-national HCP meetings and complying with the codes and transparency requirements
- Mergers and acquisitions – Post-deal due diligence and integration challenges
The following issues were presented as essential:
- Compliance monitoring
- Compliance programs analysis
- Individual accountability
- Compliance as a shared responsibility
This event emphasized the fact that global pharmaceutical companies are looking to “roll-out” one coherent, flexible & secure, compliance, transparency, regulation or Sunshine & Aggregate solution. Such a system would respect local compliance & transparency regulations and laws while allowing a cohesive & global vision.
The conferences reminded that compliance covers a larger scope, among which medical or scientific and promotional material: it is indeed important to differentiate both types of communications and to understand how Medical & Marketing departments collaborate during the whole product’s lifecycle. The numerous documents and approvals, involving different departments, make the lifecycle process complicated to manage.
As of right now, most pharma companies have already implemented compliance programs and solutions. The next step is to build data analytics systems to anticipate and rapidly identify potential compliance issues as well as to cover a bigger part of the product life cycle: from R&D to Patient Support Programs.