2017 PDA Biosimilars Conference Brochure by Parenteral Drug Association

The Parenteral Drug Association presents the...

2017 PDA Biosimilars Conference June 26-27, 2017 | Bethesda, MD Hyatt Regency Bethesda Exhibition: June 26-27

#2017Bio Register by May 12, 2017 and save up to $200!

Keys to Developing Effective CMC Strategies for Obtaining Biosimilar Approval pda.org/2017Bio This preliminary agenda is current as of March 20, 2017

RECORDINGS ARE PROHIBITED AT ALL PDA EVENTS

2017 PDA BIOSIMILARS CONFERENCE – 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

Vince R. Anicetti Coherus BioSciences Laurie Graham FDA Barbara Rellahan Amgen Jens Schletter, PhD Sandoz Marjorie A. Shapiro, PhD FDA Michael VanDerWerf Halozyme Therapeutics, Inc. Brooke Schneider, CMP PDA Planning Committee Liaison Josh Eaton, PMP PDA

Stephan O. Krause, PhD Emanuela Lacana, PhD AstraZeneca Biologics FDA

Despite the existing need to bring more lower-cost biologics to patients, to date, only a few biosimilar products have been approved in the U.S. What constitutes a suitable control strategy for biosimilars is currently not well established. Practical guidance and successful case studies for small- to large-scale bridging studies, the demonstration of analytical similarity and the setting of product specifications are largely missing.

In response to the industry’s need for current and reliable information on this rapidly growing area of pharmaceutical manufacturing, PDA is offering the 2017 Biosimilars Conference. 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 current agencies’ expectations for approval of biosimilars. Multiple speakers from various health authorities will provide their experience and views on key aspects for a biosimilar CMC development program and set the framework for what should be included in a marketing application. Subsequent sessions and panel discussions will address expectations and practical considerations for analytical similarity, demonstration of analytical similarity, post-marketing change management, a control strategy for biosimilars, product specifications for biosimilars and data quality expectations in biosimilar development. Throughout the Conference, 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 regulatory agencies, including the U.S. FDA, EMA and Health Canada will be presented, and CMC reviewer perspectives will elucidate those CMC issues that have been most challenging to approve. Attendees will have the opportunity to raise questions and concerns for discussion during the Conference. We invite you to attend this important Conference and to be a part of the interesting and practical discussion. We look forward to seeing you in Bethesda!

Exhibition: June 26-27

#2017Bio

GENERAL INFORMATION, REGISTRATION LEARNING OBJECTIVES FOUR WAYS TO REGISTER 1. CLICK 2. FAX 3. MAIL 4. PHONE

www.pda.org/2017Bio +1 (301) 986-1093 PDA Global Headquarters Bethesda Towers 4350 East West Highway, Suite 600 Bethesda, MD 20814 USA (301) 656-5900 ext. 115

VENUE Hyatt Regency Bethesda 1 Bethesda Metro Ctr. Bethesda, MD 20814 USA Phone: +1 (301) 657-1234 Website: bethesda.regency.hyatt.com Rate: Single: $219, plus applicable state and local taxes. Cut Off Date: May 29, 2017 (Rooms must be secured by this date in order to receive the PDA rate). Rates are guaranteed until the PDA block of rooms are sold out on a first come basis.

Participants will gain current knowledge from industry and regulatory experts and be able to: • Discuss the latest advancements and strategies required to successfully bring biosimilars to market • Interpret the latest regulatory expectations and industry standards for demonstrating analytical similarity • Explain the use of risk-based approaches to setting product specifications for Tiers 1 and 2 quality attributes • Identify successful development strategies for biosimilars • Summarize approaches for global post-marketing change control • Illustrate how analytical similarity can be demonstrated and practical control strategies be developed

CONFERENCE REGISTRATION HOURS Monday, June 26: 7:15 a.m. – 5:30 p.m. Tuesday, June 27: 7:30 a.m. – 4:00 p.m.

DRESS/ATTIRE

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.

Business casual attire is recommended for the 2017 PDA Biosimilars Conference. Since the temperature in meeting rooms tends to be cool, please bring a jacket or sweater for your comfort.

The CPE Monitor will reject any CPE credit requests submitted past 60 days from date of ACPE accredited activity. Always submit CPE activity claims as soon as possible and by the deadline specified on the CPE credit request form.

SPECIAL REQUIREMENTS

2017 PDA Biosimilars Conference ACPE # 0116-0000-17-007-L04-P | 1.233 CEUs Type of Activity: Knowledge

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

Exhibition/Sponsorship Inquiries David Hall Vice President, Sales Tel: +1 (240) 688-4405 Email: hall@pda.org

Registration Customer Care Tel: +1 (301) 656-5900 ext. 115 Email: registration@pda.org

2017 PDA BIOSIMILARS CONFERENCE – GENERAL INFORMATION

2017 PDA Biosimilars Conference June 26-27, 2017 | Hyatt Regency Bethesda | Bethesda, MD

2017 PDA BIOSIMILARS CONFERENCE – AGENDA

Connecting People, Science and Regulation®

MONDAY, JUNE 26, 2017 AGENDA 7:15 a.m. – 5:30 p.m. Registration Open 7:15 a.m. – 8:30 a.m. Continental Breakfast 8:15 a.m. – 8:30 a.m. Welcome and Opening Remarks Stephan O. Krause, PhD, Director of QA Technical Support, AstraZeneca Biologics, and Co-Chair, 2017 PDA Biosimilars Conference Program Planning Committee 8:30 a.m. – 10:30 a.m. P1: Opening Plenary: Current Agency Expectations for Approval of Biosimilars Moderator: Vince R. Anicetti, SVP Quality and Compliance, Coherus BioSciences Session Description: The Opening Plenary will cover current health authorities’ expectations for approval of biosimilars, featuring multiple speakers from various health authority regulatory bodies. They will provide their experience and views on key aspects for a biosimilar CMC development program and set the framework for what should be included in a marketing application. 8:30 a.m. – 8:50 a.m. Steven Kozlowski, MD, Supervisory Medical Officer, CDER, FDA 8:50 a.m. – 9:10 a.m. Elena Wolff-Holz, MD, Medical Assessor, Paul-Ehrlich-Institut (Invited) 9:10 a.m. – 9:30 a.m. Nancy Green, PhD, Chief, Hormones and Enzymes Division, Health Canada | Santé Canada (Invited) 9:30 a.m. – 10:30 a.m. Panel Discussion Nancy Green, PhD, Chief, Hormones and Enzymes Division, Health Canada | Santé Canada (Invited) Steven Kozlowski, MD, Supervisory Medical Officer, CDER, FDA Elena Wolff-Holz, MD, Medical Assessor, Paul-Ehrlich-Institut (Invited) 10:15 a.m. – 7:00 p.m. Exhibit Area Open 10:30 a.m. – 11:15 a.m. Refreshment Break and Poster Presentations in Exhibit Area

Exhibition: June 26-27

MONDAY, JUNE 26, 2017 AGENDA (CONTINUED)

#2017Bio

11:15 a.m. – 12:45 p.m. P2: Strategies for Reverse Engineering Moderator: Michael VanDerWerf, Senior Director, Regulatory Affairs CMC, Halozyme Therapeutics, Inc. Session Description: The first step in biosimilar development is to adequately define and understand the reference biological product; this requires thorough analytical characterization and a strategy for producing the molecule to have similar structural and functional attributes as the originator’s product. This session will explore the “reverse engineering” approaches developers take, including patent and literature searches, characterization of the innovator molecule and the planning that goes into cell line development and clone selection for producing a biosimilar. 11:15 a.m. – 11:45 a.m. Industry Representative Invited 11:45 a.m. – 12:15 p.m. Industry Representative Invited 12:15 p.m. – 12:45 p.m. Questions and Answers/Discussion 12:45 p.m. – 2:00 p.m. Networking Luncheon 2:00 p.m. – 3:20 p.m. P3: Expectations and Practical Considerations for Analytical Similarity: Industry Case Studies Moderator: Barbara Rellahan, Director, Product Quality, Amgen Session Description: A demonstration that a proposed biosimilar product is highly similar to its reference product is the foundation of a biosimilar development program. This session will provide regulatory and industry perspectives on the expectations, approaches (including lessons learned) and challenges for development/approval of a biosimilar. 2:00 p.m. – 2:20 p.m. Lessons Learned from an Etanercept Biosimilar Development/Approval Process Jens Schletter, PhD, Head Regulatory CMC Group Biopharmaceuticals, Sandoz 2:20 p.m. – 2:40 p.m. Best Practices and Lessons Learned for Demonstrating Analytical Similarity Emily Shacter, PhD, Independent Consultant, ThinkFDA, LLC 2:40 p.m. – 3:00 p.m. Biosimilar Development Case Studies Jeff Yant, PhD, Biosimilars Operations Director, Amgen 3:00 p.m. – 3:20 p.m. Patrick J. Lynch, PhD, Biologist, CDER, FDA

2017 PDA BIOSIMILARS CONFERENCE – AGENDA

2017 PDA Biosimilars Conference June 26-27, 2017 | Hyatt Regency Bethesda | Bethesda, MD

2017 PDA BIOSIMILARS CONFERENCE – AGENDA

Connecting People, Science and Regulation®

MONDAY, JUNE 26 – TUESDAY, JUNE 27, 2017 AGENDA 3:20 p.m. – 4:00 p.m. Refreshment Break and Poster Presentations in Exhibit Area 4:00 p.m. – 5:30 p.m. P4: Expectations and Practical Considerations for Analytical Similarity: Panel Discussion Moderator: Marjorie A. Shapiro, PhD, Chief, Laboratory of Molecular and Developmental Immunology, CDER, FDA Session Description: This panel discussion includes presenters from P3 and some additional panelists. Panel Discussion Brigitte Brake, PhD, Head of Unit Pharmaceutical Biotechnology, Biologics, Inspections, BfArM (Federal Institute for Drugs and Medical Devices), Germany (Invited) Nancy Green, Chief, Hormones and Enzymes Division, Health Canada | Santé Canada (Invited) Patrick J. Lynch, PhD, Biologist, CDER, FDA Jens Schletter, PhD, Head Regulatory CMC Group Biopharmaceuticals, Sandoz Emily Shacter, PhD, Independent Consultant, ThinkFDA, LLC Jeff Yant, PhD, Biosimilars Operations Director, Amgen 5:30 p.m. – 7:00 p.m. Networking Reception and Poster Presentations in Exhibit Area

TUESDAY, JUNE 27, 2017 7:30 a.m. – 4:00 p.m. Registration Open 7:30 a.m. – 8:30 a.m. Continental Breakfast 8:30 a.m. – 10:00 a.m. P5: Post-Marketing Change Management Moderator: Jens Schletter, PhD, Head Regulatory CMC Group Biopharmaceuticals, Sandoz Biopharmaceuticals Session Description: This session will examine current thinking from industry and regulators on requirements for post-approval changes to biosimilar products. It will present experiences and lessons learned from post-approval changes of specific biosimilars that have globally been on the market for many years. 8:30 a.m. – 9:00 a.m. Experiences from 10 Years of Global Post-Marketing of a Biosimilar Monika Lang-Salchner, PhD, Head Regulatory CMC Oncology Products, Sandoz Biopharmaceuticals 9:00 a.m. – 9:30 a.m. Brigitte Brake, PhD, Head of Unit Pharmaceutical Biotechnology, Biologics, Inspections, BfArM (Federal Institute for Drugs and Medical Devices), Germany (Invited) 9:30 a.m. – 10:00 a.m. Questions and Answers/Discussion 9:45 a.m. – 4:00 p.m. Exhibit Area Open

Exhibition: June 26-27

TUESDAY, JUNE 27, 2017 AGENDA (CONTINUED)

#2017Bio

10:00 a.m. – 10:45 a.m. Refreshment Break and Poster Presentations in Exhibit Area 10:45 a.m. – 12:15 p.m. P6: Control Strategy for Biosimilars Moderator: Laurie Graham, Acting Director, Division of Internal Policies and Programs, CDER, FDA Session Description: The development of an appropriate control strategy ensures that critical quality attributes are within the appropriate range, limit or distribution to assure quality. This session will focus on the lifecycle development of control strategies for biosimilar products, which will include consideration for the unique features of biosimilar product control strategies, such as the relationship, throughout development, between the control strategy and analytical similarity. 10:45 a.m. – 11:15 a.m. Maria-Teresa Gutierrez Lugo, PhD, Chemist, CDER, FDA 11:15 a.m. – 11:45 a.m. Deborah Baly, PhD, Vice President, Quality Control, Coherus (Invited) 11:45 a.m. – 12:15 p.m. Questions and Answers/Discussion 12:15 p.m. – 1:30 p.m. Networking Luncheon 1:30 p.m. – 3:00 p.m. P7: Product Specifications for Biosimilars Moderator: Stephan O. Krause, PhD, Director of QA Technical Support, AstraZeneca Biologics Session Description: This session focuses on the determination of which Tier 1-3 (critical) quality attributes should become product release/stability specifications. Industry and agency perspectives will be provided and discussed. Questions such as whether specifications can be justified based on a combination of reference product and biosimilar manufacturing capability and product stability will be answered. 1:30 p.m. – 2:00 p.m. Leslie Rivera Rosado, PhD, Director Regulatory Review Officer, CDER, FDA 2:00 p.m. – 2:30 p.m. Helmut Lerch, PhD, Head Compliance Development Biopharma, Sandoz (Invited) 2:30 p.m. – 3:00 p.m. Questions and Answers/Discussion 3:00 p.m. – 3:45 p.m. Refreshment Break and Poster Presentations in Exhibit Area

2017 PDA BIOSIMILARS CONFERENCE – AGENDA

2017 PDA Biosimilars Conference June 26-27, 2017 | Hyatt Regency Bethesda | Bethesda, MD

2017 PDA BIOSIMILARS CONFERENCE – AGENDA

Connecting People, Science and Regulation®

TUESDAY, JUNE 27, 2017 AGENDA (CONTINUED) 3:45 p.m. – 5:15 p.m. P8: Closing Plenary: Data Quality Expectations in Biosimilar Development Moderator: Emanuela Lacana, PhD, Associate Director for Biosimilars and Biologics Policy, CDER, FDA Session Description: This session will explore additional considerations for biosimilars development, discussing the type of data needed to support a biosimilars program. 3:45 p.m. – 4:15 p.m. Kate Hutterer, Senior Scientist, Amgen, Inc. (Invited) 4:15 p.m. – 4:45 p.m. Joel Welch, PhD, Acting Review Chief, CDER, FDA (Invited) 4:45 p.m. – 5:15 p.m. Panel Discussion 5:15 p.m. Closing Remarks Emanuela Lacana, PhD, Associate Director for Biosimilars and Biologics Policy, CDER, FDA, and Co-Chair, 2017 PDA Biosimilars Conference Program Planning Committee

The Parenteral Drug Association presents the…

2017 PDA Biosimilars Conference June 26-27, 2017 | Bethesda, MD Hyatt Regency Bethesda Exhibition: June 26-27 #2017Bio

SPONSORSHIP AND EXHIBIT OPPORTUNITIES ARE AVAILABLE! The 2017 PDA Biosimilars Conference offers exciting and unique sponsorship and exhibition packages designed to strengthen brand image, increase visibility and help you connect with industry leaders. This Conference will bring together VPs, directors, department heads, managers and senior scientists from biopharmaceuticals, bioprocessing, clinical immunology, product development, scale-up, quality assurance and regulatory. Good foot traffic is one thing; good leads are another. At this Conference, 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 exhibit and/or sponsorship information, please contact: David Hall, Vice President, Sales Direct: +1 (240) 688-4405 | Email: hall@pda.org

Four easy ways to register – Click: www.pda.org/2017Bio Fax: +1 (301) 986-1093 (USA) Mail: PDA Global Headquarters 4350 East West Highway, Suite 600 Bethesda, MD 20814 USA Call: +1 (301) 656-5900 ext. 115

2017 PDA Biosimilars Conference June 26-27, 2017 | Bethesda, MD Hyatt Regency Bethesda Exhibition: June 26-27

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

2 CONFERENCE Registration | June 26-27

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 $ 1,895

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 $ 2,174

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* For this member type or discounted rate, online registration is not available and must be faxed in.

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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 cancelation notice is not received by April 27, 2017, your credit card will be charged 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 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 April 27, 2017, 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 cancelation. For more details, contact PDA at info@pda.org or +1 (301) 656-5900. PLEASE NOTE THAT PHOTO ID WILL BE REQUIRED IN ORDER TO PICK UP BADGE MATERIALS ON-SITE. THIS IMPORTANT SECURITY PROCEDURE WILL PREVENT ANYONE OTHER THAN THE REGISTRANT FROM PICKING UP THEIR BADGES AND MATERIALS. RECORDING/PHOTO RELEASE: By registering for these events, I authorize PDA to record and photograph me and to use the recordings/photographs in all formats and media for any purpose, including for education, marketing and trade purposes. I hereby release PDA from all claims arising out of the use of the recordings/photographs, including without limitation all claims for compensation, libel, invasion of privacy or violation of copyright ownership. Tape recordings are prohibited at all PDA Conferences. PDA USE ONLY Date:

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062717B

Exhibition: June 19-20

2017 PDA Quality Risk Management PAGE TITLE for Manufacturing Systems Workshop

#2017QRM

June 19-20, 2017 | Chicago, IL Hyatt Centric Chicago Magnificent Mile Exhibition: June 19-20

#2017QRM

Effective and Practical Application of QRM to the Design, Qualification and Operation of Pharmaceutical Manufacturing Systems

pda.org/2017QRM

Photo courtesy of Sartorius AG

This preliminary agenda is current as of March 20, 2017

RECORDINGS ARE PROHIBITED AT ALL PDA EVENTS

2017 PDA QUALITY RISK MANAGEMENT FOR MANUFACTURING SYSTEMS WORKSHOP â&#x20AC;&#x201C; GENERAL INFORMATION

2017 PDA Quality Risk Management for Manufacturing Systems Workshop

The Parenteral Drug Association presents the... June 19-20, 2017 | Hyatt Centric Chicago Magnificent Mile | Chicago, IL

2017 PDA QUALITY RISK MANAGEMENT FOR MANUFACTURING SYSTEMS WORKSHOP – GENERAL INFORMATION

Connecting People, Science and Regulation®

PROGRAM PLANNING COMMITTEE

A MESSAGE FROM THE PROGRAM CO-CHAIRS Dear Friends, Colleagues and Peers:

Program Co-Chairs:

On behalf of the Program Planning Committee, we would like to invite you to attend the 2017 PDA Quality Risk Management for Manufacturing Systems Workshop taking place in Chicago, IL, Jun. 19-20.

Hal Baseman ValSource, LLC Ghada Haddad, MBA Merck & Co./Merck, Sharp & Dohme

Liza M. Lamb Wright Medical Technology Kevin O’Donnell, PhD Health Products Regulatory Authority Lori Richter ValSource, LLC Christopher J. Smalley, PhD Pharmaceutical Consultant William Stelzenmuller Janssen, Pharmaceutical Companies of Johnson & Johnson Kelly Waldron, MBA Dublin Institute of Technology Steve Wisniewski CAI Consulting Molly O’Neill Moir, CMP PDA Planning Committee Liaison Rich Levy, PhD PDA

The Committee’s goal from the start was to create this Workshop as highly interactive. Rather than ask attendees to simply listen to presentations about principles of QRM, we wanted attendees to participate in breakout sessions and encourage dialogue on such important topics as the use of QRM approaches for the characterization of critical aspects of system design, the qualification of those systems and the integration of QRM principles into the pharmaceutical manufacturing system.

Hal Baseman ValSource, LLC

Ghada Haddad, MBA Merck & Co./Merck, Sharp & Dohme

Our robust agenda, focusing on Effective and Practical Application of QRM to the Design, Qualification and Operation of Pharmaceutical Manufacturing Systems, includes industry and regulatory speakers who will share their expert opinions on the value and role of quality risk management in the modern manufacturing system lifecycle. The Workshop will be based on PDA’s practical and effective approaches to using QRM for key decision making in the lifecycle of manufacturing systems, which will be published in the upcoming PDA Technical Report No. 54-5, PDA Quality Risk Management for the Design, Qualification and Operation of Manufacturing Systems. Attendees will apply the principles outlined in TR 54-5 with the guidance of the primary authors and regulators. Plenary sessions will share information on risk assessment and risk-based approaches to characterizing the system design, practical implementation of QRM and more. During breakout sessions, attendees will perform a hands-on risk assessment of a given process and use the information to develop lifecycle-focused quality system plans and approaches for commissioning qualification and validation, change control, deviation management, CAPA and investigations. After the breakout sessions, the groups will reconvene to share results, ask questions and identify remaining challenges. The second day of the Workshop will open with a breakfast session meeting of the Quality Risk Management Interest Group. Join the meeting to learn, promote and share best practices that can help incorporate and advance QRM activities to support continual improvement of products and processes. Refreshment breaks and the Networking Luncheon will provide opportunities to visit the Exhibit Areas to see the latest technologies and services and to network with your fellow attendees. Take part in this important Workshop to gain best practices and a better understanding of regulatory expectations. We look forward to seeing you in Chicago!

Exhibition: June 19-20

#2017QRM

GENERAL INFORMATION, REGISTRATION LEARNING OBJECTIVES FOUR WAYS TO REGISTER 1. CLICK 2. FAX 3. MAIL 4. PHONE

www.pda.org/2017QRM +1 (301) 986-1093 PDA Global Headquarters Bethesda Towers 4350 East West Highway, Suite 600 Bethesda, MD 20814 USA (301) 656-5900 ext. 115

VENUE Hyatt Centric Chicago Magnificent Mile 633 North Saint Clair St. Chicago, IL 60611 USA Phone: +1 (312) 787-1234 Website: www.chicagomagnificentmile.centric.hyatt.com Rate: Single: $259, plus applicable state and local taxes. Cut-Off Date: May 22, 2017 (Rooms must be secured by this date in order to receive the PDA rate). Rates are guaranteed until the PDA block of rooms are sold out on a first come basis.

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 mail 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. Always submit CPE activity claims as soon as possible and by the deadline specified on the CPE credit request form. 2017 PDA Quality Risk Management for Manufacturing Systems Workshop ACPE # 0116-0000-17-008-L04-P | 1.3 CEUs Type of Activity: Knowledge

Upon completion of this Workshop, you will be able to: • Explain the importance and value of quality risk management (QRM) for the design, qualification, operation and maintenance of manufacturing systems and apply the principles using hands-on case studies • Describe the practical role of quality risk management and its use within a QMS • Recognize best practices and lessons learned from implementing QRM and how to conduct effective risk assessments • Demonstrate QRM and risk-based thinking to make decisions for the prioritization of efforts and the logical utilization of resources to qualify and operate manufacturing systems • Discuss the challenges of effective decision making to achieve manufacturing efficiency and compliance

WHO SHOULD ATTEND Project engineers, project managers, commissioning and validation professionals, quality assurance personnel, auditors and decision makers.

WORKSHOP REGISTRATION HOURS Monday, June 19: 7:00 a.m. – 5:30 p.m. Tuesday, June 20: 7:00 a.m. – 4:00 p.m.

DRESS/ATTIRE Business casual attire is recommended for the 2017 PDA Quality Risk Management for Manufacturing Systems Workshop. 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 Workshop Inquiries Molly O’Neill Moir, CMP Vice President, Programs & Meetings Tel: +1 (301) 656-5900 ext. 132 Email: moir@pda.org

Exhibition/Sponsorship Inquiries David Hall Vice President, Sales Tel: +1 (240) 688-4405 Email: hall@pda.org

Registration Customer Care Tel: +1 (301) 656-5900 ext. 115 Email: registration@pda.org

2017 PDA QUALITY RISK MANAGEMENT FOR MANUFACTURING SYSTEMS WORKSHOP – GENERAL INFORMATION

2017 PDA Quality Risk Management for Manufacturing Systems Workshop June 19-20, 2017 | Hyatt Centric Chicago Magnificent Mile | Chicago, IL

2017 PDA QUALITY RISK MANAGEMENT FOR MANUFACTURING SYSTEMS WORKSHOP – AGENDA

Connecting People, Science and Regulation®

MONDAY, JUNE 19, 2017 AGENDA 7:00 a.m. – 5:30 p.m. Registration Open 7:00 a.m. – 8:15 a.m. Continental Breakfast 8:00 a.m. – 8:15 a.m. Welcome and Opening Remarks Ghada Haddad, MBA, Director, Global Quality Risk Management Center of Excellence, Merck & Co./Merck, Sharp & Dohme, and Co-Chair, 2017 PDA Quality Risk Management for Manufacturing Systems Workshop Program Planning Committee 8:15 a.m. – 9:45 a.m. P1: Opening Plenary: The Value and Evolving Role of Quality Risk Management of the Manufacturing System Lifecycle Moderator: Ghada Haddad, MBA, Director, Global Quality Risk Management Center of Excellence, Merck & Co./Merck, Sharp & Dohme Session Description: The pharmaceutical industry has an integral role in protecting patients by supplying quality products. However, they can also put lives at risk if they don’t maintain quality of their products by evaluating the robustness of their manufacturing processes to understand and manage potential risk to product quality and thus patient safety. ICH Q8, 9 and 10 were created to ensure that the quality of products is built into the processes and monitored within a quality management system. Quality risk management (QRM) enables the systematic process for the assessment, control, communication and review of risks to the quality of the medicinal product across the product lifecycle. The importance and value of QRM is highly dependent on its use and the commitment a company puts towards integration of QRM principles in their quality systems. QRM with good manufacturing practice (GMP) and science can be a powerful tool for scientific based decision making to ensuring quality. Unfortunately practice shows that the real role of QRM is not always understood, and it has become something that is only done because it is required by the regulations. Kevin O’Donnell, PhD, will give the regulatory perspective on the value and role of QRM while Jackie Kunzler will discuss the value and role of QRM from an industry perspective, focusing on risk-based lifecycle management. 8:15 a.m. – 8:45 a.m. Value and Role of Quality Risk Management: Regulatory Perspective Kevin O’Donnell, PhD, Market Compliance Manager, Health Products Regulatory Authority 8:45 a.m. – 9:15 a.m. Value and Role of Quality Risk Management: Industry Perspective Jackie Kunzler, Vice President of Global Quality, Baxter International Inc. (Invited) 9:15 a.m. – 9:45 a.m. Questions and Answers/Discussion 9:30 a.m. – 6:30 p.m. Exhibit Area Open 9:45 a.m. – 10:30 a.m. Refreshment Break in Exhibit Area

Exhibition: June 19-20

MONDAY, JUNE 19, 2017 AGENDA (CONTINUED)

#2017QRM

10:30 a.m. – 12:30 p.m. P2: Risk Assessment and Risk-Based Approaches to Characterizing the System Design Moderator: Lori Richter, Consultant, ValSource, LLC Session Description: Two risk-based approaches for characterizing the system design will be presented. The first is a traditional system impact approach that identifies and evaluates critical system components and items against a prescribed set of criteria. The second is a process-driven approach, which builds on evaluation of process risk to select and rank system elements. The session will also include a discussion on modern methods for system and process risk assessment. 10:30 a.m. – 11:10 a.m. System-Driven Approach Liza M. Lamb, Validation Engineer III, Wright Medical Technology 11:10 a.m. – 11:55 a.m. Process-Driven Approach Kelly Waldron, MBA, Regulatory Science Researcher, Dublin Institute of Technology 11:55 a.m. – 12:30 p.m. Questions and Answers/Discussion 12:30 p.m. – 1:45 p.m. Networking Luncheon 1:45 p.m. – 3:15 p.m. Breakout Session Moderator: Hal Baseman, Chief Operating Officer, ValSource, LLC, and Co-Chair, 2017 PDA Quality Risk Management for Maufacturing Systems Workshop Program Planning Committee Each breakout group will perform a risk assessment of a given process. The groups will then use one of the two risk-based methods presented or discuss alternate methods to assess, determine, evaluate and rank risks, critical aspects and control strategies for manufacturing systems needed to fulfill design requirements. Groups will prepare and present feedback to the larger group on approach effectiveness, results, remaining challenges and suggestions for meeting those challenges. The results of the session will be compared and critiqued, including any differing results. The results will then be used as a basis for user requirements needed for the second set of breakout groups on day two.

Group 1 Facilitator: William Stelzenmuller, Principal Quality Engineer, Janssen, Pharmaceutical Companies of Johnson & Johnson Group 2 Facilitator: Steve Wisniewski, Principal Compliance Consultant, CAI Consulting Group 3 Facilitator: Liza M. Lamb, Validation Engineer III, Wright Medical Technology Group 4 Facilitator: Lori Richter, Consultant, ValSource, LLC Group 5 Facilitator: Kelly Waldron, MBA, Regulatory Science Researcher, Dublin Institute of Technology Group 6 Facilitator: Christopher J. Smalley, PhD, Pharmaceutical Consultant

3:15 p.m. – 4:00 p.m. Refreshment Break in Exhibit Area

2017 PDA QUALITY RISK MANAGEMENT FOR MANUFACTURING SYSTEMS WORKSHOP – AGENDA

2017 PDA Quality Risk Management for Manufacturing Systems Workshop June 19-20, 2017 | Hyatt Centric Chicago Magnificent Mile | Chicago, IL

2017 PDA QUALITY RISK MANAGEMENT FOR MANUFACTURING SYSTEMS WORKSHOP – AGENDA

Connecting People, Science and Regulation®

MONDAY, JUNE 19 – TUESDAY, JUNE 20, 2017 AGENDA 4:00 p.m. – 5:30 p.m. P3: Group Reports and Panel Discussion Moderator: Hal Baseman, Chief Operating Officer, ValSource, LLC Session Description: Breakout group moderators will present their results to attendees. Attendees will have an opportunity to ask questions and critique results. 4:00 p.m. – 5:00 p.m. Group Reports 5:00 p.m. – 5:30 p.m. Panel Discussion Richard L. Friedman, MS, Deputy Director, Science & Regulatory Policy, CDER, FDA (Invited) Jackie Kunzler, Vice President of Global Quality, Baxter International Inc. (Invited) Liza M. Lamb, Validation Engineer III, Wright Medical Technology Kevin O’Donnell, PhD, Market Compliance Manager, Health Products Regulatory Authority Kelly Waldron, MBA, Regulatory Science Researcher, Dublin Institute of Technology 5:30 p.m. – 6:30 p.m. Networking Reception in Exhibit Area

TUESDAY, JUNE 20, 2017 7:00 a.m. – 4:00 p.m. Registration Open 7:00 a.m. – 8:30 a.m. Continental Breakfast 7:15 a.m. – 8:15 a.m. Breakfast Session: MSOP/Aging Facilities and the Use of New Technologies Moderator: Rich Levy, PhD, Senior Vice President, Science and Regulatory Affairs, PDA Session Description: TBD 7:15 a.m. – 7:30 a.m. Maik W. Jornitz, CEO, G-CON Manufacturing Inc. 7:30 a.m. – 8:15 a.m. Questions and Answers/Discussion

Exhibition: June 19-20

TUESDAY, JUNE 20, 2017 AGENDA (CONTINUED)

#2017QRM

8:30 a.m. – 10:00 a.m. P4: Practical Implementation of Quality Risk Management for Manufacturing System Lifecycle Moderator: Christopher J. Smalley, PhD, Pharmaceutical Consultant Session Description: TBD 8:30 a.m. – 9:00 a.m. The Use of Risk-Based Thinking to Promote the Use of Modern Technology Richard L. Friedman, MS, Deputy Director, Science & Regulatory Policy, CDER, FDA (Invited) 9:00 a.m. – 9:30 a.m. Advanced QRM Training Initiatives for GMP Inspectors/Investigators: An Overview of the PIC/S Expert Circle on QRM Kevin O’Donnell, PhD, Market Compliance Manager, Health Products Regulatory Authority 9:30 a.m. – 10:00 a.m. Questions and Answers/Discussion 9:45 a.m. – 4:00 p.m. Exhibit Area Open 10:00 a.m. – 10:45 a.m. Refreshment Break in Exhibit Area 10:45 a.m. – 12:45 p.m. P5: Quality Systems: Quality Risk Management Approaches for Designing a More Effective Pharmaceutical Quality System Moderator: William Stelzenmuller, Principal Quality Engineer, Janssen, Pharmaceutical Companies of Johnson & Johnson Session Description: Quality risk management (QRM) is regarded as a proactive approach toward assuring quality of products and the safety of patients. QRM with its processes should be clearly defined in the quality manual and should be an integrated part of quality management in the operation of pharmaceutical manufacturing systems. QRM integration into the pharmaceutical quality system (PQS) will ensure an effective and efficient PQS with more informed decisions and an appropriate allocation of resources. In this presentation, we will discuss the use of QRM in the system qualification, corrective action/preventive action (CAPA) program, change management programs, investigations and other aspects of quality systems. 10:45 a.m. – 11:15 a.m. Use of Risk-Based Approaches for Planning and Performance of System Commissioning, Qualification and Validation of Critical Systems Steve Wisniewski, Principal Compliance Consultant, CAI Consulting 11:15 a.m. – 11:45 a.m. Risk-Based Approach to Manufacturing System Design and Operation: Linking to Product Quality and Process Requirements Christopher J. Smalley, PhD, Pharmaceutical Consultant 11:45 a.m. – 12:15 p.m. Building a More Efficient and Effective Quality System Lori Richter, Consultant, ValSource, LLC 12:15 p.m. – 12:45 p.m. Questions and Answers/Discussion 12:45 p.m. – 2:00 p.m. Networking Luncheon

2017 PDA QUALITY RISK MANAGEMENT FOR MANUFACTURING SYSTEMS WORKSHOP – AGENDA

2017 PDA Quality Risk Management for Manufacturing Systems Workshop June 19-20, 2017 | Hyatt Centric Chicago Magnificent Mile | Chicago, IL

2017 PDA QUALITY RISK MANAGEMENT FOR MANUFACTURING SYSTEMS WORKSHOP – AGENDA

Connecting People, Science and Regulation®

TUESDAY, JUNE 20, 2017 AGENDA (CONTINUED) 2:00 p.m. – 3:30 p.m. Breakout Session Moderator: Ghada Haddad, MBA, Director, Global Quality Risk Management Center of Excellence, Merck & Co./Merck, Sharp & Dohme Breakout groups will reconvene with facilitators to use information on system critical aspects and user requirements developed during the Breakout Session 1 assessments, to develop lifecycle-focused quality system plans and approaches for commissioning qualification and validation, change control, deviation management, CAPA and investigations. Each group will discuss the practical value of the assessment, and present its findings, results, remaining challenges and suggestions for meeting those challenges to all attendees.

3:30 p.m. – 4:15 p.m. Refreshment Break in Exhibit Area 4:15 p.m. – 5:45 p.m. P6: Closing Plenary: Report Out and Panel Discussion Moderator: Ghada Haddad, MBA, Director, Global Quality Risk Management Center of Excellence, Merck & Co./Merck, Sharp & Dohme Session Description: Breakout group facilitators will present their results to attendees. Attendees will have an opportunity to ask questions, critique results, determine where challenges remain and suggest future efforts to best meet these challenges. 4:15 p.m. – 5:15 p.m. Group Reports 5:15 p.m. – 5:25 p.m. Survey Readout 5:25 p.m. – 5:45 p.m. Panel Discussion Richard L. Friedman, MS, Deputy Director, Science & Regulatory Policy, CDER, FDA (Invited) Kevin O’Donnell, PhD, Market Compliance Manager, Health Products Regulatory Authority Lori Richter, Consultant, ValSource, LLC Christopher J. Smalley, PhD, Pharmaceutical Consultant Steve Wisniewski, Principal Compliance Consultant, CAI Consulting 5:45 p.m. Closing Remarks Hal Baseman, Chief Operating Officer, ValSource, LLC, and Co-Chair, 2017 PDA Quality Risk Management for Manufacturing Systems Workshop Program Planning Committee

Exhibition: June 19-20

#2017QRM

The Parenteral Drug Association presents the...

2017 PDA Quality Risk Management for Manufacturing Systems Workshop June 19-20, 2017 | Chicago, IL Hyatt Centric Chicago Magnificent Mile Exhibition: June 19-20 #2017QRM

EXHIBITION AND SPONSORSHIP OPPORTUNITIES Exhibit and sponsorship opportunities at the 2017 PDA Quality Risk Management for Manufacturing Systems Workshop enable your company to connect with professionals and decision makers from the biopharmaceutical science and manufacturing industry. Meet attendees during breaks and the Networking Reception and share how your company is aligned with and can help them address new developments and innovations in the field. Take advantage of this opportunity to introduce new products and services to this relevant and interested audience. This Workshop is an essential meeting for anyone involved or planning to be involved with existing and new pharmaceutical manufacturing systems. Create the best sponsorship opportunity for your company to place your brand in front of influential industry professionals. For more information about exhibit and sponsorship opportunities, please contact: David Hall, Vice President, Sales Cell: +1 (240) 688-4405 | Email: hall@pda.org

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2017 PDA QUALITY RISK MANAGEMENT FOR MANUFACTURING SYSTEMS WORKSHOP â&#x20AC;&#x201C; AGENDA

2017 PDA Quality Risk Management for Manufacturing Systems Workshop June 19-20, 2017 | Hyatt Centric Chicago Magnificent Mile | Chicago, IL

Four easy ways to register – Click: www.pda.org/2017QRM Fax: +1 (301) 986-1093 (USA) Mail: PDA Global Headquarters 4350 East West Highway, Suite 600 Bethesda, MD 20814 USA Call: +1 (301) 656-5900 ext. 115

2017 PDA Quality Risk Management for Manufacturing Systems Workshop June 19-20, 2017 | Chicago, IL Hyatt Centric Chicago Magnificent Mile Exhibition: June 19-20

1 Contact Information Prefix

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Last Name

Job Title

Company

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

Fax Special Dietary Requirements (Please be specific):

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.

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

2 WORKSHOP Registration | June 19-20

Please check appropriate fee (US$). Before Apr. 10, 2017

Apr. 10 – May 5, 2017

After May 5, 2017

PDA Member

 $ 1,895

 $ 2,095

 $ 2,295

Non-member

 $ 2,174

 $ 2,374

 $ 2,574

Government/Health Authority

Member Non-member*

 $ 700

 $ 800

Academic

Member Non-member*

 $ 700

 $ 800

Student

Member Non-member*

 $ 280

 $ 310

* For this member type or discounted rate, online registration is not available and must be faxed in.

3 Payment Options

Group Registration: Register 4 people from the same organization as a group (at the same time) for the WORKSHOP

All cards are charged in US$. and receive the 5th registration free. 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: Total amount $

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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 cancelation notice is not received by April 20, 2017, your credit card will be charged 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 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 Workshop/Event: If your written request is received on or before April 20, 2017, 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 Workshop 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 cancelation. For more details, contact PDA at info@pda.org or +1 (301) 656-5900. PLEASE NOTE THAT PHOTO ID WILL BE REQUIRED IN ORDER TO PICK UP BADGE MATERIALS ON-SITE. THIS IMPORTANT SECURITY PROCEDURE WILL PREVENT ANYONE OTHER THAN THE REGISTRANT FROM PICKING UP THEIR BADGES AND MATERIALS. RECORDING/PHOTO RELEASE: By registering for these events, I authorize PDA to record and photograph me and to use the recordings/photographs in all formats and media for any purpose, including for education, marketing and trade purposes. I hereby release PDA from all claims arising out of the use of the recordings/photographs, including without limitation all claims for compensation, libel, invasion of privacy or violation of copyright ownership. Tape recordings are prohibited at all PDA Conferences. PDA USE ONLY Date:

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062017B

2017 DATES

PDA Schedule of Events

EVENT

LOCATION

APRIL 3-5

2017 PDA Annual Meeting

Anaheim, CA

APRIL 5-6

2017 PDA Cell and Gene Therapy Workshop

Anaheim, CA

APRIL 26-27

2017 PDA Europe Current Trends in Aseptic Fill & Finish for Pre-filled Syringes

Lindau, Germany

MAY 8-9

2017 PDA Container Closure, Devices and Delivery Systems: Compatibility and Material Safety Workshop

Washington, DC

MAY 10

2017 PDA Pre-filled Syringe Interest Group Meeting

Bethesda, MD

MAY 11

2017 PDA Combination Products Interest Group Meeting

Bethesda, MD

MAY 30-JUNE 1

2017 PDA Europe Virus & TSE Safety Forum

Dubrovnik, Croatia

JUNE 13-14

2017 2nd PDA Europe Annual Meeting

Berlin, Germany

JUNE 19-20

2017 PDA Quality Risk Management for Manufacturing Systems Workshop

Chicago, IL

JUNE 26-27

2017 PDA Biosimilars Conference

Bethesda, MD

JUNE 27-28

2017 PDA Europe Advanced Therapy Medicinal Products

Valencia, Spain

SEPTEMBER 11-13

2017 PDA/FDA Joint Regulatory Conference

Washington, DC

SEPTEMBER 13-14

2017 PDA PAC iAM Workshop

Washington, DC

SEPTEMBER 19-20

2017 PDA Europe Pharmaceutical Freeze Drying Technology

Cologne, Germany

SEPTEMBER 26-27

2017 PDA Europe 10th Workshop on Monoclonal Antibodies

Berlin, Germany

SEPTEMBER 27-29

2017 PDA Europe Training Week Visual Inspection

Berlin, Germany

OCTOBER 2-3

2017 PDA Annex 1 Workshop

Washington, DC

OCTOBER 10-11

2017 PDA Europe Pharmaceutical Cold & Supply Chain Logistics

Prague, Czech Republic

OCTOBER 16-18

12th Annual PDA Conference on Pharmaceutical Microbiology

Bethesda, MD

OCTOBER 18-19

2017 PDA Endotoxins Workshop

Bethesda, MD

OCTOBER 23-24

2017 PDA Visual Inspection Forum

Bethesda, MD

NOVEMBER 7-8

2017 PDA Europe The Universe of Pre-filled Syringes & Injection Devices

Vienna, Austria

NOVEMBER 21-22

2017 PDA Europe Outsourcing & Contract Manufacturing

Munich, Germany

2017 PDA Cell and Gene Therapy Conference

San Diego, CA

DECEMBER 5-6

Subject to change www.pda.org/calendar

CURRENT AS OF 3/20/2017