CHAPTER 2

Regulatory and contract compliance

To effectively manage regulatory risks you should have a framework to consider the impact of new and pending regulations on third-party relationships.

STAYING ON TOP OF PRESENT AND EMERGING REGULATIONS

PHARMA

Requirements for the identification of regulated pharmaceutical products throughout their entire life cycle, from development to approval to marketing.

GDPR

General Data Protection Regulation requires all organizations that hold, transmit or process European Union resident data to comply, regardless of whether you or your third party actually operate in the EU.
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FCPA

Compliance with the Foreign Corrupt Practices Act (FCPA) and other similar global anti-corruption laws becomes a business imperative as you leverage resources abroad and expand globally.

IDMP

Identification of Medicinal Products international standards allow for unique identification of regulated pharmaceutical products through the full life cycle, development through marketing. 

FDA REGS

Increased scrutiny underscores the importance to evaluate FDA compliance frequently.

DID YOU KNOW?

To achieve optimal contract management:

  • Maintain a central repository for all contract agreements
  • Assign responsibility for management and oversight
  • Complete periodic contract reviews and address areas needing updates or improvements
  • Manage key dates and ongoing due diligence from financial provisions to legal filings

Essential contract compliance management

 

Effective third-party management requires appropriate controls and a deep understanding of roles and responsibilities outlined in your provider contract. Contract compliance management is essential as failure to properly oversee these agreements could mean costly contractual missteps and lost profits.

 

To uncover these risk areas, a comprehensive contract compliance audit should be completed on existing contracts to assess whether your third parties are meeting their agreement obligations.

Does your organization use questionnaires or surveys to assess third parties?

ALWAYS
SOMETIMES
NO
UNSURE
RSM recommends using a survey to assess third parties prior to contracting. This allows you to compare data and information across third-party candidates.
 
When used regularly, surveys uncover issues and potential risks before formalizing contract agreements.

RSM's third-party vendor management portal helps monitor your vendor's compliance.

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