2018 PDA Biosimilars Workshop

pda.org/2018Biosimilars

2018 PDA Biosimilars Workshop Getting It Right the First Time for Biosimilar Marketing Applications

September 26-27, 2018 | Washington, DC Exhibition: September 26-27 Courses: September 27-28 #PDABIOSIMILARS This Agenda is current as of July 17, 2018 RECORDINGS ARE PROHIBITED AT ALL PDA EVENTS

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2018 PDA BIOSIMILARS WORKSHOP – GENERAL INFORMATION

Connecting People, Science and Regulation®

PROGRAM PLANNING COMMITTEE

A MESSAGE FROM THE PROGRAM CO-CHAIRS

Program Co-Chairs: Stephan O. Krause, PhD AstraZeneca Biologics Emanuela Lacana, PhD FDA

Bev Ingram, PhD Pfizer Inc. Alla Polozova, PhD Amgen Inc. Barbara Rellahan, PhD Amgen Inc. Jens Schletter, PhD Novartis Joel T. Welch, PhD FDA Josh Eaton PDA Brooke Schneider, CMP PDA

Stephan O. Krause, PhD AstraZeneca Biologics

Emanuela Lacana, PhD FDA

Dear Friends, Colleagues, and Peers: Despite the existing need to bring lower-cost biologics to patients, to date, the approval of biosimilar products in the U.S. has proven to be challenging.

Challenges include the implementation of a suitable control strategy for biosimilars; the demonstration of analytical similarity, particularly the use of statistical tools to support analytical similarity; and understanding regulatory agencies’ expectations for the submission of CMC information in the application.

In response to the industry’s need for current and reliable information on this rapidly growing area of pharmaceutical manufacturing, PDA is offering the 2018 PDA Biosimilars Workshop. The Program Planning Committee has developed an agenda that brings together industry experts and regulators to review and discuss new development strategies for biosimilars.

The opening plenary will cover agencies’ current expectations for approval of biosimilars, featuring multiple speakers from various health authorities.

They will provide their experience and views on key aspects for a biosimilar CMC development program. The framework for what should be included in a marketing application will also be covered.

Subsequent sessions and panel discussions will address high-level technical challenges in biosimilar development, such as data quality expectations or the creation of a control strategy, and the role of statistical tools in the demonstration of analytical similarity, with a focus on common issues and practical challenges and options and solutions.

Throughout the Workshop, successful case studies and practical examples will be used to illustrate how analytical similarity can be demonstrated and practical control strategies can be developed. Current updates from the regulatory agencies, including the U.S. FDA, the EMA, and Health Canada, will be presented, and CMC reviewers will provide perspectives on the challenges encountered in reviewing CMC information. Attendees will have the opportunity to raise questions and concerns.

We invite you to attend this important Workshop and to be a part of the interesting and practical discussion.

We look forward to seeing you in Washington, DC!

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Sincerely, Co-chairs, 2018 PDA Biosimilars Workshop Program Planning Committee

GENERAL INFORMATION REGISTER NOW Online: pda.org/2018Biosimilars Fax: +1 (301) 986-1093 Questions? Please call +1 (301) 656-5900 ext. 115

VENUE Renaissance Washington, DC Downtown Hotel 999 9th Street NW Washington, DC, USA 20001 Phone: +1 (202) 898-9000 Website: https://book.passkey.com/go/PDAFDA18 Rate: Single/Double: $317, plus applicable taxes Cut-off Date: Friday, August 10, 2018 A PDA block of rooms is available on a first-come, first-served basis and must be secured by the cut-off date to receive the PDA rate. After the cut-off date, rooms will be available at the prevailing rate based on availability.

CONTINUING EDUCATION CREDITS PDA is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Pharmacy Education (CPE) credits. To do so, participants must sign in at the beginning of the program, submit the provided evaluation forms, and email the CPE credit request to the address stated on the form. Attendees must be present at the full event to receive CPE credit.

ALERT: ACPE and the National Association of Boards of Pharmacy developed the Continuing Pharmacy Education (CPE) Monitor that allows pharmacists to electronically track their CPE credits. The CPE Monitor will reject any CPE credit requests submitted past 60 days from date of ACPE accredited activity. No exceptions can be given. Always submit CPE activity claims as soon as possible and by the deadline specified on the CPE credit request form.

2018 PDA Biosimilars Workshop ACPE # 0116-0000-18-016-L04-P | 1.025 CEUs Type of Activity: Knowledge

LEARNING OBJECTIVES Participants will gain knowledge from industry and regulatory experts and be able to: • Discuss the latest advancements and strategies required to successfully bring biosimilars to market • Identify successful development strategies for biosimilars • Illustrate how analytical similarity can be demonstrated and practical control strategies be developed

WHO SHOULD ATTEND VPs | Directors | Heads | Managers | Senior Scientists Professionals with intermediate to advanced knowledge and experience in the following: Biotechnology | Bioanalytics | Biomanufacturing | Biopharmaceuticals | Bioprocessing | Biosimilars | Biotherapeutics | Cell Line | Clinical Immunology | Development | Commercial Biologics | Drug Safety and Risk Management | Expression Systems | Immunogenicity Testing | Market Entry | Partnering and Licensing | Patient Safety | Product Development | Protein Characterization | Scale-up Processes | Quality Assurance | Regulatory Affairs | Regulatory CMC

WORKSHOP REGISTRATION HOURS Wednesday, September 26: 11:30 a.m. – 6:30 p.m.

Thursday, September 27: 7:30 a.m. – 6:15 p.m.

COURSE REGISTRATION HOURS Thursday, September 27: 7:30 a.m. – 4:00 p.m.

Friday, September 28: 7:30 a.m. – 4:00 p.m.

DRESS/ATTIRE

2018 PDA BIOSIMILARS WORKSHOP – GENERAL INFORMATION

2018 PDA Biosimilars Workshop

Getting It Right the First Time for Biosimilar Marketing Applications September 26-27, 2018 | Washington, DC Exhibition: September 26-27 #PDABIOSIMILARS

Business casual attire is recommended for all events. Since the temperature in meeting rooms tends to be cool, please bring a jacket or sweater for your comfort.

SPECIAL REQUIREMENTS If you require special accommodations to fully participate, please attach a written description of your needs with your registration form. Specific questions can be directed to registration@pda.org.

CONTACT INFORMATION Conference Inquiries Brooke Schneider, CMP, Manager, Programs Tel: +1 (301) 656-5900 ext. 111 | Email: schneider@pda.org Registration Customer Care Tel: +1 (301) 656-5900 ext. 115 | Email: registration@pda.org Exhibition/Sponsorship Inquiries David Hall, Vice President, Sales Tel: +1 (240) 688-4405 | Email: hall@pda.org Education Course Series Inquiries Stephanie Ko, Senior Manager, Lecture Education Tel: +1 (301) 656-5900 ext. 151 | Email: ko@pda.org

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2018 PDA BIOSIMILARS WORKSHOP – AGENDA

Connecting People, Science and Regulation®

WEDNESDAY, SEPTEMBER 26 11:30 a.m. – 6:30 p.m.

Registration Open

1:45 p.m. – 2:00 p.m.

Welcome and Opening Remarks from Workshop Co-Chair Stephan O. Krause, PhD, Director, QA Technology, AstraZeneca Biologics 2:00 p.m. – 3:15 p.m.

P1: Regulatory Perspective on Biosimilar Marketing Applications Moderator: Stephan O. Krause, PhD, Director, QA Technology, AstraZeneca Biologics This session will explore the challenges encountered with submission of biosimilar marketing applications from the regulatory agencies’ perspectives. The presentations will provide an overview of challenges encountered during the assessment of biosimilar marketing applications, with a focus on manufacturing development, commercial production, and control strategy. Expectations for a successful submission of the CMC information will also be described.

2:00 p.m. – 2:20 p.m.

FDA Perspective on Biosimilar Marketing Applications U.S. Regulatory Representative Invited 2:20 p.m. – 2:40 p.m.

Evolving EU Views on Analytical Similarity R. Martijn van der Plas, PhD, Senior Assessor Biologicals, Medicines Evaluation Board (MEB) The Netherlands 2:40 p.m. – 3:00 p.m.

Health Canada Perspective on Biosimilar Marketing Applications Chantal Depatie, PhD, Biologist Evaluator, Health Canada 3:00 p.m. – 3:15 p.m.

Questions and Answers/Discussion 3:00 p.m. – 7:30 p.m.

Exhibit Area Open 3:15 p.m. – 4:00 p.m.

Refreshment Break in Exhibit Area 4:00 p.m. – 5:30 p.m.

Concurrent Breakouts These breakout sessions will offer a deep dive into regulatory authorities’ expectations and common issues observed to date in review of biosimilar dossiers by agencies in different regions. The objective is to highlight specific gaps and shortfalls using fictional case studies and to obtain a mutual understanding of both the authorities’ expectations and the limitations and challenges industry is facing in biosimilar development to meet these expectations. Participants will have an interactive discussion to collectively dissect the problems and brainstorm solutions.

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Breakout 1 Moderator: Marjorie A. Shapiro, PhD, Supervisory Biologist, Chief, Laboratory of Molecular and Developmental Immunology, CDER, FDA Record Keeper: Alla Polozova, PhD, Principal Scientist, Amgen Inc.

Breakout 2 Moderator: Chantal Depatie, PhD, Biologist Evaluator, Health Canada Record Keeper: Jens Schletter, PhD, Head RA CMC Biosimilars, Novartis

WEDNESDAY, SEPTEMBER 26 – THURSDAY, SEPTEMBER 27 (CONTINUED) 5:30 p.m. – 6:30 p.m.

Panel Discussion Moderator: Stephan O. Krause, PhD, Director, QA Technology, AstraZeneca Biologics, and Jens Schletter, PhD, Head RA CMC Biosimilars, Novartis Chantal Depatie, PhD, Biologist Evaluator, Health Canada U.S. Regulatory Representative Invited Emanuela Lacana, PhD, Associate Director for Biosimilars and Biologics Policy, CDER, FDA R. Martijn van der Plas, PhD, Senior Assessor Biologicals, Medicines Evaluation Board (MEB) The Netherlands Marjorie A. Shapiro, PhD, Supervisory Biologist, Chief, Laboratory of Molecular and Developmental Immunology, CDER, FDA 6:30 p.m. – 7:30 p.m.

Networking Reception in Exhibit Area

THURSDAY, SEPTEMBER 27

2018 PDA BIOSIMILARS WORKSHOP – AGENDA

2018 PDA Biosimilars Workshop

Getting It Right the First Time for Biosimilar Marketing Applications September 26-27, 2018 | Washington, DC Exhibition: September 26-27 #PDABIOSIMILARS

7:30 a.m. – 6:15 p.m.

Registration Open 7:30 a.m. – 8:30 a.m.

Continental Breakfast 8:30 a.m. – 9:45 a.m.

P2: The Trapeze and the Trap Door: Navigating High-Level Technical Challenges in Biosimilar Development Moderator: Joel T. Welch, PhD, Acting Review Chief, CDER, FDA This session will describe approaches to addressing high-level technical challenges and avoiding pitfalls frequently encountered during biosimilar candidate development, including data quality expectations, the creation of the final control strategy, and strategic choices necessary for candidate selection and development. Both a regulatory perspective and industry experiences will be shared. Presentations will provide practical perspective on developing “fit for purpose” analytical methods, inspectional expectations, the intersection of the analytical similarity assessment with the proposal of a final control strategy, and critical strategic decisions necessary in a biosimilar development program.

8:30 a.m. – 8:50 a.m.

Data Quality Jee Chung, PhD, Biologist, CDER, FDA 8:50 a.m. – 9:10 a.m.

Control Strategy Catherine A. Srebalus Barnes, PhD, Senior Director, Biosimilars Analytical R&D, Pfizer Inc. 9:10 a.m. – 9:30 a.m.

A Systematic Approach to Establish a Manufacturing Control Strategy in Biosimilar Development: A Regulatory Perspective Daeseok Choi, PhD, Regulatory Affairs, CELLTRION, Inc. 9:30 a.m. – 9:45 a.m.

Questions and Answers/Discussion 9:30 a.m. – 4:00 p.m.

Exhibit Area Open

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2018 PDA BIOSIMILARS WORKSHOP – AGENDA

Connecting People, Science and Regulation®

THURSDAY, SEPTEMBER 27 (CONTINUED) 9:45 a.m. – 10:30 a.m.

Refreshment Break in Exhibit Area 10:30 a.m. – 11:30 a.m.

Concurrent Breakouts These breakout sessions will provide an interactive discussion of the key messages and issues described in the session presentations. Meeting attendees will have the opportunity to vote on which two session topics they would like to focus in the breakouts. Case studies and examples will be provided to facilitate breakout discussions. Themes, concerns, and critical questions and gaps will be identified and summarized for follow up in the session’s panel discussion.

Breakout 1 Moderator: Barbara Rellahan, PhD, Director, Product Quality, Amgen Inc. Record Keeper: U.S. Regulatory Representative Invited

Breakout 2 Moderator: Catherine A. Srebalus Barnes, PhD, Senior Director, Biosimilars Analytical R&D, Pfizer Inc. Record Keeper: U.S. Regulatory Representative Invited

11:30 a.m. – 12:30 p.m.

Panel Discussion Moderator: Joel T. Welch, PhD, Acting Review Chief, CDER, FDA Daesok Choi, PhD, Regulatory Affairs, CELLTRION, Inc. Jee Chung, PhD, Biologist, CDER, FDA Catherine A. Srebalus Barnes, PhD, Senior Director, Biosimilars Analytical R&D, Pfizer Inc. 12:30 p.m. – 2:00 p.m.

Lunch on Your Own. Exhibit Area Closed. A listing of local restaurants is available at the PDA Registration Desk.

2:00 p.m. – 3:15 p.m.

P3: Demonstrating Analytical Similarity: The Role of Statistical Tools Moderator: Bev Ingram, PhD, Senior Director, Portfolio Lead Biosimilars Regulatory Affairs, Pfizer Inc. This session will explore the use of statistical tools to provide meaningful contributions to the demonstration of analytical similarity. The presentations will highlight common issues and practical challenges that arise during the application of statistical tools. Solutions and options that could be used to address the known challenges will be discussed, including practical alternative solutions to current approaches. Experiences and opinions from regulatory agencies outside the U.S. will be shared to complement the details presented in the U.S. FDA draft guideline (statistical approaches to evaluate analytical similarity).

2:00 p.m. – 2:20 p.m.

Statistical Tools for Demonstrating Analytical Similarity: Range Tests, Equivalence Tests of Means, and Distribution Comparisons Richard K. Burdick, PhD, Chief Statistician, Elion Labs, a division of KBI Biopharma, Inc. 2:20 p.m. – 2:40 p.m.

Performance Characteristics of Commonly Used Statistical Approaches in the Evaluation of Analytical Similarity Thomas Stangler, Regulatory CMC Team Leader, Novartis 2:40 p.m. – 3:00 p.m.

Reflections on Comparability (Similarity) and Methodology R. Martijn van der Plas, PhD, Senior Assessor Biologicals, Medicines Evaluation Board (MEB) The Netherlands

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3:00 p.m. – 3:15 p.m.

Questions and Answers/Discussion

THURSDAY, SEPTEMBER 27 (CONTINUED) 3:15 p.m. – 4:00 p.m.

Refreshment Break in Exhibit Area 4:00 p.m. – 5:00 p.m.

Concurrent Breakouts This breakout session is intended to foster discussion on the practical challenges of applying statistical tools to support the demonstration of similarity; the nature of the data generation during biosimilar product development; the practical challenges experienced when statistical tools are applied and the approaches to the similarity study design; the potential strategies that can be considered; and alternative solutions and options to address the known issues. Participants will be invited to propose solutions that can be applied to common challenges and consider how statistical outputs can be complemented by other data supporting the biosimilar application, including control strategy and process knowledge.

Breakout 1 Moderator: Jens Schletter, PhD, Head RA CMC Biosimilars, Novartis Record Keeper: Alla Polozova, PhD, Principal Scientist, Amgen Inc.

Breakout 2 Moderator: Stephan O. Krause, PhD, Director, QA Technology, AstraZeneca Biologics Record Keeper: Thomas Stangler, Regulatory CMC Team Leader, Novartis

2018 PDA BIOSIMILARS WORKSHOP – AGENDA

2018 PDA Biosimilars Workshop

Getting It Right the First Time for Biosimilar Marketing Applications September 26-27, 2018 | Washington, DC Exhibition: September 26-27 #PDABIOSIMILARS

5:00 p.m. – 6:00 p.m.

Panel Discussion Moderator: Bev Ingram, PhD, Senior Director, Portfolio Lead Biosimilars Regulatory Affairs, Pfizer Inc. Richard K. Burdick, PhD, Chief Statistician, Elion Labs, a division of KBI Biopharma, Inc. Stephan O. Krause, PhD, Director, QA Technology, AstraZeneca Biologics Emanuela Lacana, PhD, Associate Director for Biosimilars and Biologics Policy, CDER, FDA R. Martijn van der Plas, PhD, Senior Assessor Biologicals, Medicines Evaluation Board (MEB) The Netherlands Alla Polozova, PhD, Principal Scientist, Amgen Inc. Thomas Stangler, Regulatory CMC Team Leader, Novartis 6:00 p.m.

Closing Remarks from Workshop Co-Chair Emanuela Lacana, PhD, Associate Director for Biosimilars and Biologics Policy, CDER, FDA

EXHIBITION AND SPONSORSHIP OPPORTUNITIES The 2018 PDA Biosimilars Workshop offers exciting and unique sponsorship and exhibition packages designed to strengthen brand image, increase visibility, and help you connect with industry leaders. This Workshop will bring together VPs, directors, department heads, managers, and senior scientists from biopharmaceuticals, bioprocessing, clinical immunology, product development, scale-up, quality assurance, and regulatory departments.

Good foot traffic is one thing; good leads are another. At this Workshop, you will have access to attendees from a variety of manufacturing companies – making this a must-attend meeting. In addition, high-profile sponsorships are available for lanyards, notepads, audience response systems, tote bags, pens, refreshment breaks, lunch, and the Networking Reception. We’ll create a customized sponsorship package to fit your needs and budget.

For more information about exhibit and sponsorship opportunities, please contact: David Hall, Vice President, Sales | Tel: +1 (240) 688-4405 | Email: hall@pda.org

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2018 PDA REGULATORY TRAINING COURSE SERIES

Connecting People, Science and Regulation®

2018 PDA REGULATORY TRAINING COURSE SERIES Following the 2018 PDA Biosimilars Workshop, from September 27-28, PDA Education will offer five courses designed to advance your knowledge.

CONTINUING EDUCATION FOR PHARMACISTS PDA is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Pharmacy Education (CPE) credits. To do so, participants must sign in at the beginning of the program, submit the provided evaluation forms, and email the CPE credit request to the address stated on the form. Attendees must be present at the full event to receive CPE credit.

ALERT: ACPE and the National Association of Boards of Pharmacy developed the CPE Monitor that allows pharmacists to electronically track their CPE credits. The CPE Monitor will reject any CPE credit requests submitted past 60 days from date of ACPE accredited activity. No exceptions can be given. Always submit CPE activity claims immediately following the event and by the deadline specified on the CPE credit request form.

CONTINUING EDUCATION FOR ENGINEERS PDA is an approved provider by the New Jersey State Board of Professional Engineers and Land Surveyors to offer courses to New Jersey Professional Engineers for Continuing Professional Competency (CPC) credit. Following the full participation in this course, participants will receive a Certificate of Accomplishment specifying the number of CPC credits that may be awarded. This certificate can be submitted as verification of completion to the Board for license renewal.

PDA is recognized by the North Carolina Board of Examiners for Engineers and Surveyors as an Approved Sponsor of CPC activities for Professional Engineers licensed by North Carolina. To receive a Certificate of Accomplishment specifying the number of Professional Development Hours (PDHs) that may be awarded, course participants must request the North Carolina Board of Examiners evaluation form from PDA staff. This form must be completed onsite at the conclusion of the course and returned to PDA staff.

Contact Stephanie Ko via email at ko@pda.org to learn more.

CLASS SCHEDULE All lecture courses begin at 8:30 a.m. and end at 4:00 p.m. Please arrive at your course location approximately 30 minutes before the start of the course to register and receive your name badge. Please be sure to bring your confirmation letter as proof of registration during check in. PDA will not allow persons to attend a course without payment or guarantee of payment.

7:30 a.m. – 8:30 a.m.: Continental Breakfast 10:00 a.m. – 10:15 a.m.: Morning Break 12:00 p.m. – 1:00 p.m.: Lunch 2:30 p.m. – 2:45 p.m.: Afternoon Break

Attendees who pre-register will now be given access to electronic course notes, which may be printed approximately 1-2 weeks in advance for use during the course. Hard copies of course notes will no longer be provided to pre-registered participants and only a limited number of hard copies will be available for onsite and transferring registrants on a first-come, first-served basis.

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September 27-28, 2018 | Washington, DC

2018 PDA REGULATORY TRAINING COURSE SERIES (CONTINUED) FOUNDATIONS OF QUALITY RISK MANAGEMENT Location: Washington, DC Date: Thursday, September 27 Duration: 1 day Time: 8:30 a.m. – 4:00 p.m.

Course Number: 529 ACPE #0116-0000-17-014-L04-P | 0.6 CEUs Type of Activity: Knowledge

This course will provide an overview of the Quality Risk Management (QRM) process with an emphasis on the principles in ICH Q9 and ICH Q10. A portion of the course will be focused on how QRM can be integrated into the Pharmaceutical Quality System and the use of QRM principles throughout the product lifecycle. The course will further build on the conceptual lessons by teaching practical skills, including a look at QRM tools, templates, facilitation tips, and managing teams and bias. Lastly, this course will close out with evaluating the power of decision making in using a risk register and a best practice approach for building a QRM program at your company.

WHO SHOULD ATTEND This course is designed for risk assessment participants, QRM facilitators, or decision makers who are new to QRM or need to refresh their knowledge in QRM basics.

This includes personnel from disciplines such as quality assurance, quality control, engineering, validation, production, and technical services who are involved in QRM activities.

LEARNING OBJECTIVES Upon completion of this course, you will be able to: • Describe the Quality Risk Management (QRM) process and explain the roles and responsibilities • Describe when, where, and how to apply risk management throughout the product lifecycle • Plan and prepare for quality risk management activities • Describe the formality associated with QRM tools • Describe the purpose of a risk register • Building a QRM program at your company

INSTRUCTORS

CMC REGULATORY COMPLIANCE STRATEGY FOR BIOPHARMACEUTICAL MANUFACTURING

Location: Washington, DC Date: Thursday, September 27 and Friday, September 28 Duration: 2 days Time: 8:30 a.m. – 4:00 p.m.

Course Number: 526 ACPE #0116-0000-17-045-L04-P | 1.2 CEUs Type of Activity: Knowledge This course will provide insights and practical guidance for the CMC teams to develop an acceptable cost-effective, risk-based CMC regulatory compliance strategy for biopharmaceutical manufacturing of recombinant proteins, monoclonal antibodies, genetically engineered viruses, and human cells from early clinical stage development through market approval. The course emphasis will focus on FDA, EMA, and ICH guidance.

WHO SHOULD ATTEND

2018 PDA REGULATORY TRAINING COURSE SERIES

2018 PDA Regulatory Training Course Series

This course is designed specifically for those involved or interested in the manufacture, control, and CMC regulatory issues related to biopharmaceuticals, including: Senior Management, Directors and Managers/Supervisors, QA/ QC, Regulatory Affairs, Manufacturing, and Process Development personnel.

LEARNING OBJECTIVES Upon completion of this course, you will be able to: • Explain the importance and underlying principles of an effective CMC regulatory strategy for biopharmaceuticals to move your products through clinical development into the marketplace • Explain the importance and underlying principles for CMC regulatory compliance of biopharmaceuticals and how this leads regulatory agencies to have different CMC regulatory requirements for biotech products compared to pharmaceuticals of chemical origin

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

Lori Richter, Senior Consultant, Valsource LLC Amanda B. McFarland, Senior Consultant, Valsource LLC

pda.org/2018RegCourses

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2018 PDA REGULATORY TRAINING COURSE SERIES

Connecting People, Science and Regulation®

2018 PDA REGULATORY TRAINING COURSE SERIES (CONTINUED) QUALITY AND COMPLIANCE MANAGEMENT FOR VIRTUAL COMPANIES NEW COURSE

Location: Washington, DC Date: Thursday, September 27 and Friday, September 28 Duration: 2 days Time: 8:30 a.m. – 4:00 p.m.

Course Number: 211 ACPE #0116-0000-18-003-L04-P | 1.2 CEUs Type of Activity: Application This combination lecture and workshop course explains the GMP, GCP, and GLP responsibilities of virtual companies or others who predominately outsource GxP-governed activities. Included in the course will be a discussion of: • Quality Unit organization and staffing in a virtual company environment, including key roles and reporting relationships to other company units • Quality Agreements • Best practices for vendor selection and management • How to be ready if the U.S. FDA visits your virtual company headquarters, what the U.S. FDA is likely to cover during such an inspection, and how to explain your mode of operation to a U.S. FDA Investigator in an effective way • How to be ready for a U.S. FDA inspection of your company as a sponsor of an NDA or BLA, whether you use a CRO or not • How to ensure your CMOs are PAI-ready

Location: Washington, DC Date: Thursday, September 27 and Friday, September 28 Duration: 2 days Time: 8:30 a.m. – 4:00 p.m.

Course Number: 541 ACPE #0116-0000-17-044-L04-P | 1.2 CEUs Type of Activity: Application

The objective of this two-day highly interactive course is to explore raw materials and their requirements – issues and solutions. It will also address how water impacts the final product, since water is the single most-used raw material within most processes. Another objective is to ensure that your organization is maintaining itself within a CGMP compliance framework to include ICH Q7, Q9, and Q11.

Case studies to include Warning Letters will be discussed to illustrate regulatory raw material issues.

WHO SHOULD ATTEND Those who will benefit will include:

This course is for managers and line employees of virtual companies with Quality Assurance GMP or GCP compliance responsibility.

• Quality professionals • Regulatory professionals • Compliance professionals • Manufacturing engineers • Quality engineers • Quality auditors • Quality control • Microbiology • Document control specialists • R & D

LEARNING OBJECTIVES

LEARNING OBJECTIVES

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

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

• Explain GMP and GCP requirements for virtual companies • Decide which elements of your quality system should be managed in house and how

• Explain how various types of raw materials may impact the user • Discuss the impact of raw materials to include any bacterial and endotoxin issues in the timely production of a product • Determine the single-most-used raw material in large molecule production and what it means to the user • Find the sources of analyses assistance for raw materials • Summarize the requirements for Phase 1 through commercial manufacturing − why safety is required as part of Phase 1 • Discuss the initiation of additional testing − when?

• Examine regulatory risk to include ICH Q7, Q9, and Q11

WHO SHOULD ATTEND

INSTRUCTOR Dave Chesney, Principal and General Manager, DL Chesney Consulting, LLC

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RAW MATERIAL REQUIREMENTS (FDA/HEALTH CANADA/ ICH/USP/EP) IN A CGMP ENVIRONMENT – ISSUES AND SOLUTIONS NEW COURSE

September 27-28, 2018 | Washington, DC

2018 PDA REGULATORY TRAINING COURSE SERIES (CONTINUED) • Discuss why to use compendial testing in lieu of non-compendial testing • Examine testing requirements − when is enough?

• Explain the impact of ASQ on sample size and attribute testing

INSTRUCTOR Barry Friedman, PhD, Consultant, Barry A. Friedman, PhD, LLC

QUALITY CULTURE ASSESSMENT TOOL AND TRAINING

Location: Bethesda, MD Date: Thursday, September 27 and Friday, September 28 Duration: 2 days Time: 8:30 a.m. – 4:00 p.m.

Course Number: 538 ACPE #0116-0000-18-019-L04-P | 1.2 CEUs Type of Activity: Application PDA has developed the Quality Culture Assessment Tool and Training to guide your company to a better understanding of quality culture, how to assess it, and what actions to take to improve it.

Before you can implement this tool at your organization, you will be provided with the required comprehensive training. Over two days, you will learn how to use this tool to effectively collect verifiable data. As a result, the tool will allow you to facilitate positive culture changes and continuous improvement within your organization.

Gain hands-on experience with the Quality Culture Assessment Tool and Training that will enable you to collect vital feedback regarding employee ownership and engagement, continuous improvement, technical excellence, leadership commitment, and communication and collaboration.

WHO SHOULD ATTEND This program will benefit pharmaceutical and biopharmaceutical manufacturing leaders who want to measure quality culture maturity at their plant sites and identify areas for improvement. This program will also prepare assessors to conduct site evaluations in a consistent and verifiable manner using the PDA Model and Tools.

LEARNING OBJECTIVES Upon completion of this course, you will be able to: • Use the Quality Culture Assessment Tool to identify strengths and opportunities for improvements across five key dimensions of quality culture • Examine evidence to consistently assess culture metrics in a wide variety of manufacturing settings • Use verifiable evidence to determine your company’s culture score • Explain the importance of strong quality culture in a manufacturing operation • Support leadership to engage site personnel in improving quality culture

2018 PDA REGULATORY TRAINING COURSE SERIES

2018 PDA Regulatory Training Course Series

INSTRUCTORS Cylia Chen-Ooi, Sr. Manager, QA, Amgen, Inc. Steven Mendivil, Sr. Advisor, International Quality External Affairs, Amgen, Inc. Chuck Bornhoeft, Associate Director – Integrated Quality Management, Upsher-Smith Laboratories, LLC Aura Hernandez, Supervisor, Quality Assurance, AstraZeneca David Talmage, Sr. Director, Education, PDA

Enhance the value of your results with two complimentary resources provided exclusively to organizations who have participated in the assessment tool training: • Quality Culture Survey PDA will send an anonymous quality culture survey for all staff at your site to complete, after which PDA will collect and compile the results.

• Benchmarking Data Your site will be provided with exclusive access to the consolidated, blinded results of companies that have already completed the quality culture assessment against which you can compare the quality culture at your site.

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2018 PDA Biosimilars Workshop September 26-27, 2018 | Washington, DC Renaissance Washington, DC Downtown Hotel Conference: Sept. 24-26 | Exhibition: Sept. 26-27 | Courses: Sept. 27-28

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REGISTER NOW Online: pda.org/2018Biosimilars Fax: +1 (301) 986-1093 (USA) Questions? Call registration at +1 (301) 656-5900 ext. 115

RESPONSE REQUIRED – PRIVACY AGREEMENT: By registering for this event, I agree to:

 Allow PDA to print my contact information (name, company, job title, city, state, country) on the attendee list distributed at the event.  Allow PDA to record and/or photograph me and to use those recordings and/or photographs in PDA promotional and marketing materials.  Allow PDA to send me promotional information via email and/or post.  Use the attendee list provided at this event only for following up with other attendees on related content presented at the event.

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Last Name

Job Title

Company Business Address City State/Province Zip Code Country Email Business Phone Fax  Substituting for (Check only if you are substituting for a previously enrolled colleague. The fee difference in the prevailing rate is due at the time of substitution. Please note that if you are a non-member substituting for a member, you will be required to pay the difference in the non-member fee.)

 Check here to become a member and receive the member price for this event. (Add $279 to your total.)

2 Premier Package | Regulatory CONFERENCE & Biosimilars WORKSHOP Registration | 4 COURSE Registration | September 27-28 Please check appropriate fee (US$).

September 24-27 Please check appropriate fee (US$).

Save up to $750!

By Jul. 16, 2018

After Jul. 16, 2018

PDA Member

 $ 3,740

 $ 4,640

Non-member

 $ 4,219

 $ 5,119

PDA #529 Foundations of Quality Risk Management (September 27) PDA #541 Raw Material Requirements (FDA/HealthCanada/ICH/USP/EP) in a CGMP Environment – Issues and Solutions (September 27-28) PDA #211 Quality and Compliance Management for Virtual Companies (September 27-28) PDA #526 CMC Regulatory Compliance Strategy for Biopharmaceutical Manufacturing (September 27-28) PDA #583 Quality Culture Assessment Tool and Training (September 27-28) ‡

Course #529

Course #541

Course #211

Course #526

 $ 1,192  $ 1,431

 $ 1,743  $ 2,092

 $ 1,743  $ 2,092

 $ 1,743  $ 2,092

 $ 795

 $ 1,162

 $ 1,162

 $ 1,162

After Aug. 13, 2018 Standard Member Non-member

 $ 1,325  $ 1,590

 $ 1,937  $ 2,324

 $ 1,937  $ 2,324

 $ 1,937  $ 2,324

Govt./Health Authority/Academic Member/Non-member*

 $ 795

 $ 1,162

 $ 1,162

 $ 1,162

Complimentary conference registration does not qualify for discount offered for Workshop.

3 WORKSHOP Registration | September 26-27 Please check appropriate fee (US$).

By Jul. 16, 2018

After Jul. 16, 2018

 $ 1,495  $ 1,695  $ 748  $ 700  $ 800  $ 700  $ 800  $ 280  $ 310

 $ 1,695  $ 1,895  $ 848  $ 700  $ 800  $ 700  $ 800  $ 280  $ 310

PDA Member Non-member Young Professional Member † Government/ Member Health Authority Non-member* Member Academic Non-member* Member Student Non-member*

* For this member type or discounted rate, online registration is not available and must be faxed in. † You must be a member to take advantage of this rate.

On or before Aug. 13, 2018 Standard Member Non-member Govt./Health Authority/Academic Member/Non-member*

* For this member type or discounted rate, online registration is not available and must be faxed in. ‡ This course will be held at the PDA Training and Research Institute in Bethesda, MD. Please see attached page for registration information.

Please note: In order to receive the prevailing rate, your registration(s) with payment must be received by PDA by 5:00 p.m. ET on or before the date noted.

Special Dietary Requirements (Please be specific): Payment Options All cards are charged in US$. Group Registration: Register 3 people from the same organization as a group (at the same time) for the WORKSHOP and receive the 4th registration free.

5

Other discounts cannot be applied. All forms MUST be faxed in together.  By Credit Card – Clearly indicate account number, expiration date, and billing address. Please bill my:  American Express  MasterCard  VISA  Credit Card Guarantee Only

Total amount $ Account Number Exp. Date Name (exactly as it appears on card) Signature Billing Address (must match credit card statement) PDA Federal Tax I.D. #52-1906152 City State Zip Code Country

Wire Transfer Payments: If you require wire transfer, please contact registration@pda.org.

CONFIRMATION: A letter of confirmation will be sent to you once payment is received. You must have this written confirmation to be considered enrolled in a PDA event. Please allow one week for receipt of confirmation letter. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. Please be advised that if your payment or written cancellation notice is not received by July 26, 2018, your credit card will be charged the prevailing rate. SUBSTITUTIONS: If you are unable to attend, substitutions can be made at any time, including onsite for a fee of $200. If you are a non-member substituting for a member, you will be required to pay the difference in the non-member fee. If you are pre-registering as a subsitute attendee, indicate this on the registration form. REFUNDS: Refund requests must be in writing and faxed to +1 (301) 986-1093. (Emails and phone messages are not accepted). Refunds for Conference/Event: If your written request is received on or before July 26, 2018, you will receive a full refund minus a $200 processing fee. After that time, no refunds or credit requests will be approved. Onsite registrants are not guaranteed to receive Conference materials until all advanced registered attendees receive them. PDA reserves the right to modify the material or speakers/instructors without notice or to cancel an event. If an event must be canceled, registrants will be notified by PDA in writing as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due to cancellation. For more details, contact PDA at info@pda.org or +1 (301) 656-5900. PLEASE NOTE THAT YOUR PHOTO ID WILL BE REQUIRED IN ORDER TO PICK UP BADGE MATERIALS ONSITE. THIS IMPORTANT SECURITY PROCEDURE WILL PREVENT ANYONE OTHER THAN THE REGISTRANT FROM PICKING UP THEIR BADGES AND MATERIALS. REFUNDS FOR COURSES: If your written request is received by August 28, 2018, you will receive a full refund minus a $200 processing fee. After that time, no refunds will be approved. COURSE CANCELLATION: PDA reserves the right to modify the material or speakers/instructors without notice, or to cancel an event. If an event must be canceled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due to cancellation. RECORDING: Tape recordings are prohibited at all PDA conferences.

PDA USE ONLY Date: Check:

Amount:

Account:

PRINT

REGISTER NOW Online: pda.org/2018SeptQCT Fax: +1 (301) 986-1093 (USA)

Quality Culture Assessment Tool and Training September 27-28, 2018 PDA Training and Research Institute 4350 East West Highway, Suite 110, Bethesda, MD 20814

Questions? Call registration at +1 (301) 656-5900 ext. 115

RESPONSE REQUIRED – PRIVACY AGREEMENT: By registering for this event, I agree to:  Allow PDA to print my contact information (name, company, job title, city, state, country) on the attendee list distributed at the event.  Allow PDA to record and/or photograph me and to use those recordings and/or photographs in PDA promotional and marketing materials.  Allow PDA to send me promotional information via email and/or post.  Use the attendee list provided at this event only for following up with other attendees on related content presented at the event.

1 Contact Information Prefix

PDA Membership Number

First Name

Job Title

Last Name

Company

Business Address City State/Province ZIP+4/Postal Code Country Email Business Phone

Fax

 Substituting for

Special Dietary Requirements (Please be specific):

(Check only if you are substituting for a previously enrolled colleague. The fee difference in the prevailing rate is due at the time of substitution.

PDA Federal Tax I.D. #52-1906152

2 Participating Site

Name: Location

3 Registration September 27-28, 2018

Member

Nonmember

Quality Culture Assessment Tool and Training

 $ 3,999

 $ 4,999

4 Payment Options

All cards are charged in US$.

By Credit Card – Clearly indicate account number, expiration date and billing address.

Please bill my: Total amount $



 

American Express  MasterCard Credit Card Guarantee Only



VISA

Account Number Exp. Date Name (exactly as it appears on card) Signature Billing Address (must match credit card statement) City State Zip Country

Wire Transfer Payments: If you require wire transfer, please contact registration@pda.org.

CONFIRMATION: A letter of confirmation will be sent to you once payment is received. You must have this written confirmation to be considered enrolled in a PDA event. Please allow one week for receipt of confirmation letter. If you have submitted a purchase order or have requested an invoice please be advised that a credit card guarantee is needed. You are not confirmed until payment has been received. Please submit payment for the prevailing rate.

SUBSTITUTIONS: If you are unable to attend, substitutions can be made at any time, including on site at the prevailing rate. If you are a non-member substituting for a member, you will be required to pay the difference of the nonmember fee. If you are pre-registering as a substitute attendee, indicate this on the registration form. REFUNDS: Refund requests must be in writing and faxed to +1 (301) 986-1093 by August 28, 2018 (emails and phone messages are not accepted). If your written request is received on or before August 28, 2018, you will receive a full refund minus a $200 handling fee. After that time, no refunds will be approved. If you are an unpaid registrant and do not attend the event, you are responsible for paying the registration fee at the on-site registration rate if your cancellation has not been received in writing on or before August 28, 2018. On-site registrants are not guaranteed to receive conference materials until all advanced registered attendees receive them. COURSE CANCELATION: PDA reserves the right to modify the material or speakers/instructors without notice, or to cancel an event. If an event must be canceled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due to cancellation. For more details, contact PDA at info@pda. org or +1 (301) 656-5900. RECORDING: Tape recordings are prohibited at all PDA events.

PDA USE ONLY Date:

Check:

Amount:

Account: