Larger pharma company regulatory affairs and quality departments are constantly being asked to do more with no increase in resources. Smaller companies and foreign companies often do not have any or enough US based staff or staff with the appropriate expertise to meet their business goals. Thus the use of consultants to provide assistance is a significant and growing trend in both the pharmaceutical and medical device industries.

But how does one go about choosing a consultant group? Use a big CRO-type organization? Contact a single proprietor? Are there alternatives to consider in terms of therapeutic area, geography, on-site or remote work, other potential add--on services that are offered, etc.? This session will present the perspectives and learnings of a senior regulatory affairs executive with decades of successful experience and who has worked in both pharma and the consultancy industries. Similarly, the second presenter will be a long-standing quality and compliance professional.

In choosing and utilizing regulatory and quality consultants for both tactical and strategic activities there are many attributes to consider. What information should you provide to allow a consultant to appropriately scope out, determine timelines and resources, and price a project? How should one compare proposals from different consultants? What should you verify with a consultant before signing the contract? An experienced consultancy executive will provide these insights and advise participants on what is needed to make the relationship work smoothly so that your objectives are fully realized.

Use of regulatory affairs and quality consultants in the device/pharma industry is projected to continue to increase by 10% or more annually. Intermediate and senior level attendees will be able to apply the information shared during the presentations and Q&A session in their normal work activities as they consider adding consultants to complete business objectives.

Learning Objectives:

• Describe the key considerations in choosing an appropriate regulatory and quality consultant to meet business objectives.

• Explain to a potential regulatory or quality consultant the essential aspects of a project that will allow an achievable timeline, service delivery, and budget to be presented for consideration.

Your presenters will be Andrew S. Verderame, Partner, PharmaLex US Corporation and Gerardo Gomez, Sr. Director Quality & Compliance, PharmaLex US Corporation.

A light breakfast will be served and there will be plenty of time for Q & A at the conclusion of the presentation.