Course Description

Biotech startups clearly understand the critical importance of their human clinical study strategy, but frequently, the development of a strategy for Chemistry, Manufacturing & Controls (CMC) is an afterthought. Add to this, the frequent lack of CMC regulatory compliance experience in some biotech startup companies, coupled with the complexity of the biological manufacturing processes and products, and this can be a recipe for disaster. CMC deficiencies for a biopharmaceutical can result in Phase 1 clinical trial holds and/or delays in entering Phase 3 pivotal clinical programs.

This course will provide insights and practical guidance for a biotech startup to develop an acceptable CMC regulatory compliance strategy for the early clinical stage development (Phase 1 and Phase 2) of their first biopharmaceutical product. This course will also present suggestions on how to organize the CMC responsibilities within a biotech startup, and how to develop a risk-managed CMC strategy that is cost-effective for a biotech startup.

Who Should Attend

This course is suitable for Senior Management, Directors and Managers/Leaders/Supervisors in the Quality Assurance/Quality Control, Regulatory and Manufacturing fields.

Learning Objectives

Upon completion of this course, you will be able to:

• Discuss current regulatory requirements and industry standards for virus safety for biologicals, biopharmaceuticals
• Discuss of the importance and underlying principles for CMC regulatory compliance of biopharmaceuticals, and how this leads regulatory agencies to have different CMC regulatory requirements for biopharmaceuticals compared to pharmaceuticals of chemical origin
• Develop a cost-effective, risk-managed CMC regulatory compliance strategy to move these products from pre-clinical stage into Phase 1 and Phase 2 clinical trials

Instructor

John Geigert, PhD, RAC, President, BioPharmaceutical Quality Solutions

Class Schedule

All lecture courses begin at 8:30 a.m. and end at 4:00 p.m. unless otherwise noted on the confirmation letter or in course information posted on the website or in the course brochures. Courses that are listed with a half day will begin at 8:30 a.m. and end at noon on the last day.

Please arrive at your course location approximately thirty minutes before the start of the course to register and receive your course materials. Please be sure to bring your confirmation letter as proof of registration during check-in. TRI will not allow persons to attend a course without payment, or guarantee of payment.

A continental breakfast will be served before class beginning 7:30 a.m. Lunch will be provided from 12:00 – 1:00 p.m. Snacks will be provided during the morning break from 10:00 – 10:15 a.m. and the afternoon break from 2:30 – 2:45 p.m.

Continuing Education Credits

The PDA Training and Research Institute is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Education Units (CEUs) following the successful completion of an accredited course and submission of the provided evaluation forms. Statements of Credit for CEUs earned will be mailed within four to six weeks of the event.

Registration Fees

Member/Nonmembers Standard	$995
Student/Academic/Government	$600

Rates in US dollars.

Location/Lodging Information

GRAND HYATT DENVER
1750 Welton Street
Denver, Colorado, USA 80202
Tel: +1 303 295 1234