• Guidance Documents for Drug Master Files (DMFs) US, Canadian and European Regulatory Requirements
• Role of DMFs in the regulatory approval process for drugs and biologics
• Comparing the Types of Drug Master Files
• Preparation of United States Drug Master File (US-DMF)
• Preparation of Canadian & European Drug Master File
• Compiling necessary document for DMF Submission
• Regulatory reviews of DMFs
• Strategies for Communications with FDA and other regulatory agencies
• EU and US efforts to harmonize DMF systems
• DMF Preparation and Requirements
• Steps of DMF preparation
• Essential Information for a Drug Master File
• Key Documents associated with DMF
• Customizing DMFs for particular products and businesses
• Binder Specifications and Cover Samples
• Annual Updates and Amendments
• Techniques for tailoring DMFs to CTD format
• Current Issues with APIs and Type II DMFs
• Assessing supplier Type III DMF’s
• Successful Preparation of Type III DMFs

Drug Master File (DMF) is a master document containing complete information on a API. It is known as US-Drug Master File (US-DMF) and European Drug Master File (EDMF) or Active Substance Master File (ASMF) in United States and Europe and respectively.

It is a submission to FDA covering factual and complete information on its chemistry, stability, purity, impurity profile, packaging and cGMP status of any API. The Main Objective of DMF is to meet regulatory requirements and for Market Authorization (MA).

Manufacturers of pharmaceuticals, pharmaceutical components, and pharmaceutical packaging are constant pressure under to ensure that their Drug Master Files (DMFs) are in order. This pressure derives from the drug applicants, who are experiencing mounting frustration and mounting costs as their drug applications are held up in review before the Food and Drug Administration (FDA) and European agencies. The submission of a DMF is required by neither law, nor regulation. As voluntary filings, there are only minimal regulations governing the submission of DMFs. Instead, FDA has issued a series of guidance documents, all of which must be considered in filing and maintaining a successful DMF. Guideline for Drug Master Files (1989 & 1994); Container Closure Systems for Packaging Human and Biologics (1999); Changes to an Approved NDA or ANDA (1999); Analytical Procedures and Methods Validation (2000); and Changes to an Approved NDA or ANDA, Questions and Answers (2001).

This comprehensive 2-day training provides attendees with an understanding of the role DMFs play in the FDA, Canadian and European regulatory approval processes. The course will take participants through a step-by-step process of DMF preparation and explain the types of information essential for any Drug Master File. Additionally, this course will discuss the current review and enforcement climate within FDA and the manner in which drug master files (DMFs) are reviewed by FDA personnel.

Mr. Frank Bieganousky Managing Associate Montesino

Frank Bieganousky has over 20 years of experience in the pharmaceutical packaging industry. He is a founding member of Montesino Associates, LLC a consulting firm with highly focused expertise in healthcare packaging and broad-based experience in plastics and general packaging. His regulatory experience includes Drug Master File audits and preparation, cGMP implementation, and packaging documentation for New Drug Applications. Areas of technical expertise include design requirements, specification and qualification of blister packaging materials, tooling and equipment, child resistant packaging and package integrity testing. Commercial experience includes business, market and product development activities. A former Director of Healthcare Business Development for Tekni-Films, his previous positions also include Package Development Manager at Bristol-Myers Squibb, as well as business development and marketing positions at AlliedSignal (now Honeywell) and Rexam Medical Packaging.

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Dr. Loren Gelber Chief Scientific Officer RRI Group Inc.

Dr. Loren Gelber is currently the Chief Scientific Officer of the RRI Group Inc. a pharmaceutical and regulatory consulting company. She has been with RRI since June of 1005. Prior to that she held various compliance positions at Andrx Pharmaceuticals, was Vice President of Regulatory Compliance at Royce Laboratories and Director of Regulatory Affairs at Danbury Pharmacal and Barr Laboratories.

Between 1975 and 1985 Dr. Gelber worked at the US Food and Drug Administration. She was a bench chemist and a reviewer of DMFs and ANDAs.

Dr. Gelber has a Ph.D. in Medicinal Chemistry from the Northeastern University School of Pharmacy and Allied Health, an MS in Chemistry from Brooklyn Polytechnic Institute and a BA in Biology from Brandeis University. She is the author of more than 30 scientific publications, presentations and book chapters.

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Dr. Norm Howe Sr. Partner Validation & Compliance Institute, LLC

Norm has held many management positions in FDA-regulated industries, most in production at BASF. He has led a number of cross-functional cost reduction, product development, and business optimization teams. He has led teams that have developed more than a dozen new products and installed more than $60M in capital. He is an adjunct Professor of Regulatory Science at the University of Michigan, Ann Arbor, and has authored articles on compliance, chemistry, and general management. He serves as an expert witness. He is a member of ISPE and the American Chemical Society. Norm Howe got his BS in chemistry at UC, Berkeley, and a PhD in chemistry at UCLA under Donald J. Cram.

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Mrs. Cornelia B. Rooks, M.A. Senior Regulatory Specialist Registrar Corp.

Mrs. Rooks was employed by the U.S. Food and Drug Administration for 25 years before retiring in 2005. She was the Director of the Division of Device User Programs and Systems Analysis (DDUPSA) within the Office of Communication, Education and Radiation Programs (OCER). Formerly, she was Branch Chief of the Clinical Chemistry/Toxicology/Hematology branch within the Division of Clinical Laboratory Devices (DCLD) (currently Office of In Vitro Diagnostic Device Evaluation and Safety, OIVD) for 7 years. OIVD regulates in vitro diagnostic devices intended for use in clinical laboratories, point of care, physician’s office laboratories and home use. DDUPSA is responsible for a number of programs within CDRH, including human factors, risk communication, labeling and qualitative research. Prior to coming to the CDRH, Mrs. Rooks was a scientific reviewer and inspector in the CBER and a drug adverse reaction reviewer within CDER. Mrs. Rooks’ background includes extensive experience in the clinical and research laboratory investigations; device, biologics and drug adverse reactions reviews and GMP inspections.

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Dr. Miguel A. de Soto-Perera Vice President of Pharmaceutical Sciences Beckloff Associates, Inc. (a Cardinal Health company)

Miguel de Soto-Perera, Ph.D., is Vice President of Pharmaceutical Sciences at Beckloff Associates, Inc. (BAI). He holds a Doctorate in Electroanalytical Chemistry, and a Master’s Degree in Analytical Chemistry, both from the University of Massachusetts at Amherst, and has 30 years of experience in the pharmaceutical industry. He is fluent in Spanish and conversant in French and Italian. Dr. de Soto-Perera also has extensive teaching experience at the undergraduate and graduate levels, and is a regular lecturer at Regulatory Workshops offered by Beckloff Associates, Inc. (BAI) both domestically and internationally.

Dr. de Soto-Perera joined the Dow Chemical Company (later to become Merrell Dow Pharmaceuticals, and subsequently Marion Merrell Dow, Inc.) as Senior Analytical Chemist immediately after obtaining his doctorate, and throughout his tenure was responsible for the development and validation of analytical methods for drug substances, drug products, biological fluids, feed matrices and dosing solutions for animal studies. He also held managerial positions in Quality Control and Quality Operations (including Quality Assurance) in the United States and Europe.

After joining BAI in September 1995, Dr. de Soto-Perera has been involved in current Good Manufacturing Practices (cGMP) audits of production and testing facilities for synthetic and biotechnology-derived active pharmaceutical ingredients (APIs), drug products, excipients, and medical devices; Pre-Approval Inspection (PAI) and cGMP compliance programs; preparation of regulatory submissions (U.S., Canadian, and European Drug Master Files [DMFs], European Certificates of Suitability [CEPs], Investigational New Drug Applications [INDs], New Drug Applications [NDAs], and Abbreviated New Drug Applications [ANDAs]); and establishment of validation programs for manufacturing processes, analytical methods and cleaning procedures. Dr. de Soto-Perera’s current responsibilities at BAI include performing GMP audits in accordance with U.S. and E.U. regulations and developing GMP compliance programs for API and drug product facilities in various countries. In his current position at BAI, Dr. de Soto-Perera is responsible for managerial, business, and technical aspects of one of the Chemistry, Manufacturing, and Control (CMC) groups and the Regulatory Compliance Group, both of which include personnel in Overland Park, KS and San Diego, CA.

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Ms. Damaris DeGraft-Johnson, RPh, MSc. Med. Chem. President DJA Global Pharmaceuticals, Inc.

Damaris has over 25 years strategic and hands-on experience in drug development and global regulatory affairs. She’s currently president of DJA Global Pharmaceuticals Inc., a successful global regulatory consulting company for the pharmaceutical, device and biotechnology industry. Prior to founding DJA she held various senior level responsibilities at DuPont Pharmaceuticals/Bristol Myers Squibb, Merck & Co. and Rhone-Poulenc Rorer (currently Sanofi-Aventis Pharmaceuticals).

She has made significant contributions to the timely resolution of complex issues related to the development, manufacture and commercialization of over 200 products in global markets. Included in this experience is preparation of numerous manufacturing sites for FDA & EU Agency inspections (GxP), and implementation of various quality systems and processes.

Damaris’ recent accomplishments include approval of 5 NDA/MAA/NDS in several therapeutic areas; 55+ agency submissions [IND/CTA/IDE] in over 30 countries; 40+ DMF/CEP submissions [human/veterinary products] in 28+ countries; 35 successful pre-approval inspections (GLP, GCP & GMP); led 35+ successful FDA/Canadian/EMEA meetings for 29+ products in all phases of development and 8 therapeutic areas.

Day 1 - Tuesday February 23, 2010
08:00 AM	Registration and Continental Breakfast
08:30 AM	Overview of US Regulatory Requirements for Drug Master Files (DMF):
	Intro to DMFs Types of DMFs Guidances for DMF types Role of DMFs in regulatory approval process for drugs Preparation of U.S. DMFs Specifications Format Essential Information Annual Updates and Amendments
09:30 AM	The DMF’s Role in the Regulatory Processes for Review of Drug and Biologic Application
	Relationship between Drug Master File (DMF) & Marketing Application The Relationship Between DMFs and cGMPs Regulatory Guidance – Health Canada, EU The rationale, function and preparation process for DMFs Why each DMFs must be customized for specific products, practices and businesses DMF Considerations in Europe for Active Substances Harmonization of DMF Systems - EU and US Efforts
10:15 AM	Mid-Morning Refreshment Break
10:30 AM	Type II Drug Master Files
	This talk covers the organization and writing of Type II DMFs. It specifically answers the question, 'How much detail is enough?' Why you need DMFs to maintain current supplier agreements as well as to develop new business relationships. Manufacture Manufacturers Description of Manufacturing Process and Process Controls Flow Diagram Description of the Manufacturing Process and Process Controls Reprocessing, Reworking, Recycling, Regeneration, and Other Operations Control of Materials Controls of Critical Steps and Intermediates Process Validation and/or Evaluation Manufacturing Process Development Characterization Elucidation of Structure and other Characteristics Impurities Control of Drug Substance Specification Analytical Procedures Validation of Analytical Procedures Batch Analyses Justification of Specification Reference Standards or Materials Container Closure System Stability Stability Summary and Conclusions Postapproval Stability Protocol and Stability Commitment Stability Data Steps of DMF Preparation and Key Documents associated with DMF
11:45 AM	Current Issues with Type II DMFs and APIs
	Relationship between APIs and DMFs Overview of FDA Drug Regulations Overview of FDA’s new electronic registration and listing requirements for API establishments Regulatory registration and listing requirements for APIs, who must register and list Definitions of establishment registration, labeler code and drug listing The electronic system of registration opening the gateway: what are the requirements/difficulties the duns number: what is it and why is it required the Standard Product Labeling(SPL) forms Transitioning existing registrations New listings using SPL forms SPL Examples
12:15 PM	Luncheon
1:15 PM	Current Issues with Type II DMFs and APIs (Continued)
1:45 PM	Assembling the Essential Components of a Comprehensive DMF
	Procedures and steps for efficient DMF preparation Complying with current DMF guidance Manufacturing processes Composite materials Validation procedures Supplier information
2:45 PM	Mid-Afternoon Refreshment Break
3:00 PM	Common Challenges and Oversight in DMF Preparation
	Consequences of non-compliant preparation and maintenance Recent enforcement actions and inspectional trends Strategies for avoiding the most common DMF-related errors
3:45 PM	Preparing Other Documents Related to the DMF
	DMF vs. Application Acknowledgement letters Letters of Authorization Transmissions- transmittal letter Binder specifications and cover samples Preparing to File a DMF Coordinated filing vs. Individual filing Following processing and review policies Determining when to file Reviewing submission documents Information necessary for effective submissions Filing using CTD format Electronic Filing vs Traditional DMFs
5:00 PM	Questions & Answers
5:00 PM	Conclusion of Day 1
Day 2 Wednesday February 24, 2010
08:00 AM	Continental Breakfast
08:30 AM	Techniques for Tailoring DMFs to CTD Format
	Applicability of Common Technical Document Format Discussions Between DMF Holder and Regulatory Application Sponsor Business and Financial Considerations Selection of Regulatory Strategy Mapping of Old DMF Formats into CTD Format Granularity of CTD Format Word Processing and Style Guides Use of Table of Contents as Project Management Tool Modular Approach Repurposing of Documents into CTD Format Country-Specific Contents of Module 1 Life Cycle Management Industry and Regulatory Agency Trends Questions and Answers
09:15 AM	Fundamentals of Type III DMFs
	Properly submitted and well maintained packaging supplier DMFs are key to any smooth NDA process. FDA deficiency letters that result from poorly organized and/or incomplete DMFs can be costly and put your company’s reputation at risk. This short, intense session will provide both Type III DMF holders and their clients with valuable insights how to do it right from the start, how to avoid deficiencies, and deal with the most frequent issues. Practical, real life examples will be shown and discussed throughout the program. Explore the benefits of a proactive approach to save your organization money and headaches: Learn how to write, organize, and submit a Type III DMF Understand the structure and composition of a robust Type III DMF Identify proper content - key pitfalls to avoid Organization tips to provide for easier DMF maintenance Annual updates and other amendments Letters of Authorization (LOAs) Dealing with deficiency letters – appropriately address FDA’s concern Assess supplier Type III DMF’s Understand the role Type III DMFs play in the FDA’s guidance on Post Approval Changes (interchangeability)
10:15 AM	Mid-Morning Refreshment Break
10:30 AM	Post Filing Activities – During Development and Commercial Phases
	Roles and Responsibilities of DMF Holders Responsibilities when referencing a DMF Keeping the DMF up to date DMF Changes and Yearly updates Communicating changes to regulatory agencies Answering Post Submission inquiries Vendor Auditing Dealing with deficiency letters and their origins
11:30 AM	Regulatory Review of DMFs: FDA reviews and Why
	What to expect throughout the DMF preparation and filing process ICH Guidelines for Impurities in Drug Substances
12:15 PM	Luncheon
01:15 PM	Maintaining Effective Communication with Regulatory Agencies, Customers and Vendors
	Communication Strategies for working with the FDA to ensure success Minimum procedures for handling special circumstances, unique situations or unfavorable reviews A Preventative approach- why effort and attention to detail in the preparation stays crucial, if a DMF is to be accepted for filing and relied upon by your customers in their FDA applications
02:15 PM	Preparing for a U.S. Food and Drug Administration Pre-approval Inspection
	Purpose and Scope of a Typical PAI Advance Notification and Typical Length of a PAI Sites Potentially Subject to a PAI Logistics of a PAI Typical Pre-PAI Requests by FDA Role of the Quality Unit in a PAI Composition of Site PAI Team Internal Pre-PAI Audit Conduct of Site Personnel During the PAI Introductory Meeting and/or Presentation at the PAI Guided Tour of the Facility Potential Systems Subject to Inspection Quality System (SOPs, Personnel Training, Validations, etc.) Raw Data to Support Regulatory Submission Close-Out Meeting Preparation of Responses to Form FDA 483 Inspectional Observations (if any) Other Potential Follow-up and Corrective Actions Questions and Answers
03:00 PM	Panel Discussion / Questions & Answers
03:30 PM	Conclusion of Program

This comprehensive program has been tailored for those involved in the manufacture of pharmaceutical and biologic products, components, and packaging materials. The course will be especially is directed toward Directors, Managers, Supervisors, and Associates in the Pharmaceutical, Biopharmaceutical, and allied industries with responsibilities involving:

• Regulatory Affairs
• CMC
• Quality Assurance
• Quality Control
• Manufacturing
• Product Development
• Preparation of Submission Materials
• Research and Development
• Project Management
• Documentation and Technical Writing
• Training
• Consulting
• Regulators
  

 

Registration Fee Includes: Presentation Materials, Luncheon, and Refreshments

Cancellation/Substitutions Policy:

All cancellations are subject to a USD $150.00/person processing fee. To receive cancellation credits for attendance at an upcoming course, IPA must be notified of the cancellation in writing (by email, mail or fax) up to 3 weeks prior to the program start date. Cancellations submitted less than 3 weeks prior to the event will not be qualified for refund or credit. Substitution of delegate/s with the member/s of the same organization is permitted at any time with no penalty.

IPA reserves the right to postpone an event, prior to which time all the registered attendees will be notified a minimum of 2 weeks in advance. IPA shall not be responsible for any air fare, hotel or transportation costs incurred by registrant/s.

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