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FDA's GMP Expectations for Phase I and First-in-Man Clinical Trials 2017

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Four Points by Sheraton Los Angeles International Airport

Four Points by Sheraton Los Angeles International Airport 9750 Airport Boulevard, Los Angeles, CA, 90045, United States

Los Angeles, CA, CA 90045

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Course "FDA's GMP Expectations for Phase I and First-in-Man Clinical Trials" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Overview:

Early clinical trials are conducted to establish initial safety of a drug. The studies are generally in small number of healthy subjects and use lower doses of the drug product. Therefore, only small amounts of investigational material are required. In order to not undertake substantial costs and to reduce regulatory burden during these early stages, the FDA has established guidelines to allow early stage investigational products to be manufactured under less stringent GMPs.

Why should you attend:

To gain an understanding of the requirements for advancing drugs from research into early clinical development and the minimum FDA requirements for phase I GMPs. To learn practical applications for implementing phase I manufacturing strategies to meet FDA requirements.

Areas Covered in the Session:

Seminar Day 1

The following topics will be discussed to provide the foundation and basis for advancing drugs into clinical development from research and providing required information to the FDA regarding these products.

  • Moving a Product out of R&D
  • CMC Requirements for an IND Study
  • Good Manufacturing Practices: Basics for Beginners
  • Raw Material Management

Seminar Day 2

The following topics will be discussed to provide the requirements for early stage products of different types and for vendor selection and management.

  • GMPs for Phase 1 IND products
  • GMPs for Combination Products and 505(b)(2) Products
  • Process Validation for Early Stage GMP

Outsourcing Early Stage Manufacturing

Agenda:

Day 1 Schedule

Lecture 1:

Issues with research grade material used for laboratory and non-clinical testing

Lecture 2:

Optimizing manufacturing processes

Lecture 3:

Raw material requirements and process development

Lecture 4:

Assessing scalability of manufacturing

Lecture 5:

Planning the CMC for a potential IND

Lecture 6:

Study Essential elements of the CMC section of an IND

Lecture 7:

Characterization of the active ingredient and finished product

Lecture 8:

Various kinds of products: drugs, biologics, botanicals, diagnostics, medical devices

Lecture 9:

Manufacturing facility, personnel and equipment requirements

Lecture 10:

Core principles of GMP Regulatory requirements for different products: drugs to medical devices

Lecture 11:

Customizing regulatory compliance to a given product

Lecture 12:

Role of discussions with the FDA

Lecture 13:

Planning for the early stage with an eye towards large scale manufacturing

Lecture 14:

Vendor management

Lecture 15:

Raw material handling issues for early stage products

Lecture 16:

Manufacturing step development

Day 2 Schedule

Lecture 1:

The scope of the FDA guidance document

Lecture 2:

Acceptable practices and practical tips

Lecture 3:

GMP requirements for exploratory clinical studies

Lecture 4:

Specific requirements for drugs, biologics and combination products

Lecture 5:

Specific issues for various kinds of combination products

Lecture 6:

Combination products with one or more new components

Lecture 7:

CMC issues for 505(b)(2) products

Lecture 8:

GMP and QSR: which to follow for a combination products

Lecture 9:

Introduction to process validation for early stage manufacturers

Lecture 10:

Step by step instructions for process validation

Lecture 11:

Process validation reports and other documentation

Lecture 12:

Developing SOPs based on validation processes

Lecture 13:

Logistics of using contract manufacturing organizations for early stage products

Lecture 14:

Pilot scale manufacturing requirements GMP-grade and non-GMP grade manufacturing

Lecture 15:

Benefits and challenges with using local and international vendors

Speaker:


Peggy J. Berry

Peggy J. Berry, MBA, RAC, is the President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development. She also provides group and one-on-one training in drug development, regulatory affairs and project management topics. Prior to founding Synergy Consulting in 2015, she was Vice President of Regulatory Affairs at Insmed (2/2015-5/2015) where she was responsible for the development and implementation of global regulatory strategies and the management and oversight of the regulatory affairs department. Prior to Insmed, she was Vice President of Regulatory Affairs and Quality at Amarin (3/2009-2/2014). She has also held a variety of senior level positions at Dyax (5/2006-3/2009), MGI Pharma (now Eisai; 7/2005-5/2006), AstraZeneca (10/2001-7/2005), and Dey Pharma (now Mylan; 12/1997-10/2001). She has also held Regulatory Affairs roles within two clinical contract research organizations (ILEX Oncology and Cato Research Ltd; 1992-1997) and has worked in review divisions at the FDA (1985-1992). In addition, Ms. Berry consults for a number of companies in the regulatory and quality area, conducts a number of training courses, and is active in the Regulatory Affairs Professionals Society. She is the editor of the 2010 book "Choosing the Right Regulatory Career" (RAPS, MD) and author of the 2011 book "Communication & Negotiation" (RAPS, MD).

Location: Los Angeles, CA Date: May 11th & 12th, 2017 and Time: 9:00 AM to 6:00 PM

Venue: Four Points by Sheraton Los Angeles International Airport

Address: Four Points by Sheraton Los Angeles International Airport 9750 Airport Boulevard, Los Angeles, CA, 90045, United States

Price:

Register now and save $200. (Early Bird)

Price: $1,295.00 (Seminar Fee for One Delegate)

Until April 10, Early Bird Price: $1,295.00 From April 11 to May 9, Regular Price: $1,495.00

Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)*

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Date and Time

Location

Four Points by Sheraton Los Angeles International Airport

Four Points by Sheraton Los Angeles International Airport 9750 Airport Boulevard, Los Angeles, CA, 90045, United States

Los Angeles, CA, CA 90045

View Map

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