Recent high-profile drug withdrawals have increased public and health-authority scrutiny of medication safety. Accordingly, regulatory authorities are now expecting pharmaceutical companies to develop strategies for assessing and minimizing risks during product development and in the post-marketing phase. To help sponsors meet these expectations and to minimize disruption to the life cycle of marketed products, PharmaNet offers risk-management services for strategic planning and for all phases of clinical development and marketing.

Plan for Risks with PharmaNet Consulting

Effective risk management begins at the earliest stages of strategic planning. PharmaNet Consulting professionals, including former senior-level FDA officials, can help you understand risk management and formulate a successful strategy to:

Identify potential risks requiring special attention

Develop Risk Minimization Action Plans (Risk MAPs)

Create Standard Operating Procedures to deal with unique situations

Comply with applicable requirements for patient privacy

Submit risk-management sections of marketing applications

Manage Risks throughout the Product Life Cycle

Effective PharmaNet risk-management services during the product development life cycle are available through two dedicated divisions: the Global Safety and Pharmacovigilance team and the Phase IV Development. These teams can assist sponsors with understanding and formulating a successful strategy to:

Design, prepare, review, and implement a risk-management plan
	Select the most beneficial type of study — pharmacoepidemiological, registry, or survey — for your post-marketing purposes
Develop tools to assess your product’s benefit/risk balance
Evaluate and characterize Risk MAPs, safety signals, and risk profiles
Assess long-term risks
Develop a pharmacovigilance plan
React to unexpected results