Parenteral Packaging. Container CIosure Best Practices Throughout the Product Life Cycle February 2018 Marriott Rome Park Hotel Rome Italy

Transcription

1 PDA Europe Conference, Exhibition, Education The Parenteral Drug Association presents: Parenteral Packaging Container CIosure Best Practices Throughout the Product Life Cycle Register by 7 January 2018 and SAVE! February 2018 Marriott Rome Park Hotel Rome Italy

2 LETTER FROM THE CHAIRS Dear Colleagues, You are warmly invited to join us in our ongoing professional discourse of latest manufacturing technologies and business trends in the Parenteral Packaging arena. PDA Europe s Conference has proven to be a must-attend event for professionals in this field. Join us in Rome / Italy, February 2018 to continue and further deepen scientific advancements and understanding of topics previously raised in this successful annual event. As proper packaging of pharmaceuticals is crucial to drug stability, this conference and the accompanying exhibition address quality of components and containers as much as aspects of processing, product distribution and storage. Excellent speakers from the industry, regulatory and academia will give detailed information about opportunities and challenges the advancing pharmaceutical packaging market faces. The conference aims to keep its attendees updated about all regulatory aspects involved in the parenteral packaging process, such as new regulations from European and US agencies, the revision of Annex 1, and PDA Technical Reports. Different materials such as glass, polymers & elastomers and their characteristics regarding supplier issues and end-user preferences will also be discussed, as well as the design of primary and secondary packaging. SCIENTIFIC PLANNING COMMITTEE Roger Asselta, Chair, Genesis Packaging Roman Mathaes, Chair, LONZA Bettine Boltres, WEST Derek Duncan, LIGHTHOUSE Claudia Heinl, SCHOTT Renaud Janssen, Datwyler Enric Jo, ReigJofre Laboratories Galen Shi, Eli Lilly Michael Spallek, Rommelag ENGINEERING Daniel Wagner, Sanofi Klaus Wuchner, Janssen-J&J Jörg Zürcher, Bayer Kerstin Wilken, PDA Europe The role of Container Closure Integrity (CCI) in product-package development, post-approval product changes and routine manufacturing will be explored, and information on aseptic processing will be given. Of equal importance to the content is to interact with the speakers and your fellow attendees. Rome will offer a comfortable yet exciting atmosphere for exchange during refreshment breaks, on-site lunches and evening receptions. Join PDA Europe s Parenteral Packaging Conference in one of the most beautiful cities in the world. Welcome to Rome! Roger Asselta, Chair, Genesis Packaging Roman Mathaes, PhD Chair, LONZA 2 pda.org/eu/parpack2018

3 WELCOME TO ROME SCHEDULE AT A GLANCE 26 February 10:00 17:00 Pre-filled Syringes Interest Group Meeting 26 February 13:00 18:00 Packaging Science Interest Group Meeting 27 February 9:00 18:30 Parenteral Packaging Conference, Exhibition 27 February 18:30 21:30 Networking Dinner 28 February 9:00 16:30 Parenteral Packaging Conference, Exhibition For latest information, please visit: pda.org/eu/parpack2018 pda.org/eu/parpack2018 3

4 INTEREST GROUP MEETING 26 February 2018, 9:00-17:00 Pre-filled Syringes 2018 Focus Topic: Improving Patient Safety and Convenience Dear Colleagues, We continually strive to develop devices that improve upon current standards of safety, provide ease of administration, and offer convenience for the end user. Be it a prefilled-syringe, pen, or auto-injector the industry trend is toward fill& finish of smaller batches and larger volumes that meet the ever-increasing quality requirements that support patient safety. The goal of this meeting is to discuss these issues with a primary focus on: 1. Challenges associated with large volume injections that either help reduce the number of injections, or actually change the route of administration from IV to SC. 2. Identification of trends and approaches in manufacturing such as the need for smaller batches, different containers and greater flexibility in fill & finish technologies. 3. Acquiring knowledge about the most up-to-date approaches related to Quality including, container/ drug interaction, zero particles, avoidance of stopper movement during air shipment, and much more. Take advantage of the open forum design offered by the small Interest Group meeting approach. Hear presentations from leading experts, interact and discuss your experiences with colleagues in round table discussions, and receive the latest information about activities of the PDA Interest Group Pre-filled Syringes. If you are interested in sharing your knowledge and experience with your colleagues, we welcome your proposal submission addressing the chosen focus topic specifically, or any other relevant topic of current interest to the industry. Please send you proposal before 15 December 2017 to the attention of Sylvia Becker, becker@pda.org Brigitte Reutter-Haerle, Vetter Pharma International GmbH, Interest Group Leader Europe Brigitte Reutter-Haerle is the Vice President of Marketing / Corporate Communications for Vetter, a leading contract development and manufacturing organization that serves the global pharma/biotech industry. She was called to this new position in September 2014 and is responsible for the company s international marketing activities, product and service management as well as HR marketing and internal communication. Between 2004 and 2014, she obtained the position of Director Corporate Marketing. In 2009, she led the communications program for Vetter s U.S. expansion. Ms. Reutter-Haerle joined Vetter in 1996, serving in the company s sales and marketing function, and transferred to corporate marketing three years later. She began her career in 1983, holding various positions in the sales organizations of firms including Hilton International and TNT Express Worldwide. Ms. Reutter-Haerle earned a B.A. and a degree in Business Administration from Baden-Wuerttemberg Cooperative State University. She has been leading the Prefilled Syringe Interest Group/Europe of the Parenteral Drug Association since pda.org/eu/parpack2018

5 Don t miss the INTEREST GROUP MEETING Packaging Science 3 rd PDA Europe Annual Meeting Global Healthcare of the Present & the Future Register by 29 April 2018 and SAVE! pda.org/eu/annual June 2018 Marriott Hotel Berlin Germany pda.org/eu/parpack2018 5

6 CONFERENCE AGENDA Tuesday, 27 February Nov :00 Welcome and Introduction Kerstin Wilken, PDA Europe Roger Asselta, Genesis Packaging Roman Mathaes, LONZA OPENING PLENARY Session 1 International Regulatory Updates Moderator: Renaud Janssen, Datwyler 9:15 Annex 1 Revision & CCIT MHRA 9:45 Secondary Packaging Considerations & Last Mile Distribution WHO, invited 10:15 A Risk-based Approach for Assessment of Pharmaceutical Packaging of Parenterals - A Regulatory Perspective US FDA, invited 10:45 Q&A, Discussion 11:15 Coffee Break, Poster Session & Exhibition Session 2 Packaging Technology Updates Moderators: Roman Mathaes, LONZA 11:45 Usability of Glass versus Polymer Ampoules: A Comparison Rommelag 12:15 Impact of Drug Formulation Variables on Packaging Functionality Eli Lilly 12:45 Engineering Considerations: Pressure and Strain Waves in Pre-Filled Syringes during Autoinjector Activation Amgen 13:15 Q&A, Discussion 14:00 Lunch Break, Poster Session & Exhibition 6 pda.org/eu/parpack2018

7 PARALLEL TRACKS Session 3 Track A Track B Manufacturing Process Moderator: Daniel Wagner, Sanofi 15:00 Investigations Carried Out on Clean Room Injection Molding of Plastic Components for Parenteral Packaging Braunform 15:30 From Blow-fill-seal Ampoules to Advanced Container Closure Systems by Blow-Fill-Insert- Seal: A review based on three case studies Rommelag Packaging Material: Glass Moderator: Claudia Heinl, SCHOTT Reduction of Particulate Contamination Generated During Bulk Vial Filling Corning Extractables Profiles of Borosilicate and Aluminosilicate Glass A Comparison Schott 16:00 Coffee Break, Poster Session & Exhibition 16:30 Case Study: Mid-Scale Production Line for Aseptic Filling and Sealing of IV-Bags Harro Hoefliger 17:00 Critical Time- & Temperature- Dependent Container Closure Integrity (CCI) Through the Sealed Drug Product Life Cycle WEST 17:30 Pressure Measurement in the Filling Line to Prevent Breakage SmartSkin, invited Lyophilization of Nested Glass Containers: Process Investigation OMPI Fused Quartz Vials for Enhanced Chemical Stability Momentive Glass Packaging Breakages: A New Testing Protocol for the Optimization of Container Filling Lines Stazione Sperimentale del Vetro 18:00 Q&A, Discussion Q&A, Discussion 18:30 Networking Dinner NETWORKING DINNER Tuesday, 27 February :30 h Join us and your colleagues to enjoy food & drinks in a casual atmosphere. pda.org/eu/parpack2018 7

8 CONFERENCE AGENDA Wednesday, 28 February 2018 Session 4 Regulatory Updates Moderators: Roger Asselta, Genesis Packaging 9:00 USP Updates WEST 9:25 Elastomer Updates Datwyler 9:50 ISO Norms Update: Rigid Container Systems and Related Accessories for Parenterals and Injectables ISO/TC 76/WG2 SCHOTT 10:15 Coffee Break, Poster Session & Exhibition PARALLEL TRACKS Session 5 Track A Track B Container Closure Integrity & Testing Moderator: Bettine Boltres, WEST 10:45 A Case Study to Address a Gap in the Device-to- Vial Interface: Stopper Push-in by Chemo Spikes An Overlooked Oncology Safety Risk WEST 11:15 Container Closure Integrity: Specific Strategies for Unique Applications pti 11:45 Proposal for Implementing the RSF Tester in a Manufacturing Environment Genentech 12:15 Development of a Platform High Voltage Leak Detection Method for Drug Product Container Closure Integrity Testing Biogen Polymers: E&L Considerations Moderator: Renaud Janssen, Datwyler Polymeric Materials in Primary Containers and Medical Devices A Lilly Perspective Eli Lilly Advancing Flexibility, Softness and Transparency with Polybutene-1 for Parenteral Applications LyondellBasell Effect of Ageing of Elastomeric Closures on their Physico/Chemical Properties and their Extractables Profile Datwyler Extractables and Leachables Evaluation of Single Use Systems for Biopharmaceuticals Moving Toward Standardization by Up-Coming USP <1665>/<665> SGS Institut Fresenius 12:45 Q&A, Discussion Q&A, Discussion 13:15 Lunch Break, Poster Session & Exhibition CLOSING PLENARY Session 6 Future Outlook Moderator: Roger Asselta, Genesis Packaging Roman Mathaes, LONZA 14:15 Systematic Assessment of pccit Method Performance and Commonly Used Artificial Leaks LONZA & Wilco 14:45 State of Packaging and Testing Technology: Parenteral Cryo Solutions Janssen J&J 15:15 Closing Keynote Speaker invited 15:45 Q&A, Discussion 16:30 End of Conference & Farewell 8 pda.org/eu/parpack2018

9 INFORMATION VENUE Marriott Park Hotel Rome Via Colonnello Tommaso Masala Rome Italy Tel: Special Rates PDA Europe has reserved a limited number of bedrooms until the 11 January Book your group rate for PDA. Single Room 100 per room and night* Double Room 120 per room and night* *Rates are per room and night, including the following services and benefits free of charge: Buffet Breakfast in the restaurant, Wireless Internet Connection (WI-FI), VAT, Taxes and Service Charge will apply. Housing at the selected hotel will be in high demand, so we strongly recommend making your reservations early. DIRECTIONS CONTACT INFORMATION Conference Inquiries Melanie Decker Director Events & Exhibitions decker@pda.org Conference Program Inquiries Sylvia Becker programs-europe@pda.org Registration Customer Care Tel: registration-europe@pda.org Education Program Inquiries Elke von Laufenberg training-europe@pda.org Exhibition/Sponsorship Inquiries Nadjeschda Gomez-Stahl Nadjeschda Gomez-Stahl expo-europe@pda.org GENERAL ADDRESS PDA Europe ggmbh Am Borsigturm Berlin, Germany Tel: Fax: CONFERENCE REGISTRATION HOURS Monday, 26 February: 9:00 17:00 Tuesday, 27 February: 8:00 17:30 Wednesday, 28 February: 8:00 12:00 Google For directions click on the picture, scan the QR-code or go to COURSE REGISTRATION HOURS Thursday, 1 March: 8:00 16:30 Friday, 2 March: 8:00 12:00 TO EXHIBIT: Exhibition and Sponsorship Opportunities are available. PDA meetings and conferences are a great opportunity for your company to gain on-site exposure in front of highlyqualified, upper-level professionals in the pharmaceutical and biopharmaceutical industry. Exhibit at PDA events and let your company s products or services become a valuable tool or resource for our attendees. 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-europe@pda.org. pda.org/eu/parpack2018 9

10 Parenteral Packaging Reg Form Page February 2018 Rome Italy This PDF-file provides an automatic fill-in function. Your signature, however, is needed in writing. Your registration is only complete upon filling in and submitting both pages of this form. 1 Registration EARLY BIRD DISCOUNT Book by 7 January 2018 to receive 200* off the conference fee only All fees given in Euro, excluding VAT (22 %) 26 February Interest Group Meeting Meeting Fee Pre-filled Syringes All Participants February Interest Group Meeting Training Course Fee Packaging Science All Participants February Conference only Conference Fee Parenteral Packaging PDA Member 1595 **Nonmember 1895 * Early Bird 700 **Regulatory/Academic 800 Poster Presenter please mark here (written approval required, conference fee applies) 1 March One-Day Training Course Training Course Fee Container Closure Development All Participants March Two-Day Workshop Workshop Fee Container Closure Integrity All Participants March Two-Day Training Course Training Course Fee Extractables and Leachables All Participants 1495 The fee includes course documentation as well as mid-session refreshments and lunch. Excellent networking opportunities with snacks and drinks will be given. The fee does not include the hotel accommodation. PDA Europe has secured a limited number of rooms at a special group rate. **Registration fee includes a one-year PDA membership if no further special discount is granted. If you do not wish to join PDA and receive the benefits of membership, please check here (same rate applies). Group Registration Discount Register 5 colleagues for the conference at the same time and receive the 5th registration free. For more information on group discounts please contact Antje Petzholdt at petzholdt@ pda.org. Other discounts cannot be applied.. Discount for Exhibiting Companies Please mark here if your company is an exhibitor to this event and you will receive the conference ticket at the special price of 1095 Euro per ticket. No further discounts are applicable with this option (as PDA Membership Discount or Group Ticket discount). 10 pda.org/eu/parpack2018

11 Reg Form Page 2 Parenteral Packaging This PDF-file provides an automatic fill-in function. Your signature, however, is needed in writing February 2018 Rome Italy 3 WAYS TO REGISTER ONLINE: pda.org/eu/parpack2018 FAX: registration-europe@pda.org 1 Your Contact Information If this form is an update to a previously submitted form, please check here. Mr. Ms. Dr. Nonmember I want to become a PDA Member. Please send me a subsription form Name (Last, First, MI) * PDA Member ID Number Job Title * Company* Department Mailing Address City Postal Code Country * Business Phone Fax Substituting for (Check only if you are substituting for a previously enrolled colleague; a nonmember substituting for member must pay the membership fee.) * This information will be published in the conference attendee list. Should you not wish us to publish these details, please contact us. 2 3 Information about Visa Matters Payment Options All registrations which will involve visa matters will have to be submitted to PDA EU four weeks prior to the start of the event at the latest. For later registrations, PDA Europe will be unable to assist participants in any visa affairs. All costs incurring in connection with visa affairs shall be borne by registrants. (This applies in particular to costs for submitting documents by courier.) Potential participants must be clients of UPS shipping agency and submit their UPS customer reference number to PDA EU (together with their registration). By Bank Transfer Beneficiary: PDA Europe ggmbh IBAN: DE BIC (SWIFT-Code): DEUTDEDBBER Bank Address: Deutsche Bank, Welfenallee 3-7, D Berlin, Germany By Credit Card American Express MasterCard VISA For your credit card information safety: Please send your details by fax only. Purchase Order Purchase Order Number Billing Address: Same as contact information address above. If not, please send your billing address to: petzholdt@pda.org Your Company VAT I.D.: This number starts by your country code with two characters (example: PDA Europe s country code starts with: DE followed by the number) PDA Europe VAT I.D.: DE Your registration is only complete upon filling in and submitting both pages of this form. Date Mandatory Signature CONFIRMATION: Transmitting your filled-in registration form constitutes a binding application for the specific event. PDA Europe will send you a confirmation including payment details. A legally binding contract is concluded once PDA Europe has sent a written invoice by mail to you. A letter of confirmation will be sent to you within one week once payment has been received. You must have this written confirmation to be considered enrolled for this PDA event. PDA Europe reserves the right to deny access to anyone unable to provide written confirmation that all dues have been fully settled. SUBSTITUTIONS: If you are unable to attend, substitutions are welcome and can be made at any time, including on site at the prevailing rate. If you are registering as a substitute attendee, please indicate this on the registration form. Changes are free of charge until 2 weeks prior to the start of the event. After this two-weeks period, there will be a charge of 100 per name change. REFUNDS: Refund requests must be sent to PDA Europe. If your written request is received on or before 7 January 2018, you will receive a full refund minus a 150 excl. VAT handling fee. After that time, no refund or credit requests will be approved. If you are an unpaid registrant and do not attend the event, you are responsible for paying the registration fee. On-site registrants are not guaranteed to receive conference materials until all advanced registered attendees receive them. PDA Europe works PCI-Compliant. EVENT 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. For more details, contact PDA at info-europe@pda.org or fax to DOCUMENTATION: With your signature you give complete picture usage right to PDA and allow to film your exhibition space and intervention in the event, including the recording of your presentation for video purposes (with your slides, voice and image). This right extends also to the use of the resulting images in film documentation for webinars and similar items produced by PDA. pda.org/eu/parpack

12 2017 PDA EUROPE CONFERENCES November Outsourcing & Contract Manufacturing Munich, Germany 2018 PDA EUROPE CONFERENCES 26 February 26 February February IG Meeting Pre-filled Syringes IG Meeting Parenteral Packaging Parenteral Packaging IG IG Rome, Italy April Vaccines Spain 8-9 May Virus Forum Florence, Italy May Pharmacopoeia Conference Vienna, Austria 5-6 June Advanced Therapy Medicinal Products Amsterdam, The Netherlands 25 June 25 June 25 June June IG Meeting Visual Inspection IG Meeting Freeze Drying IG Meeting Quality Systems 3rd PDA Europe Annual Meeting IG IG IG Berlin, Germany October Pharmaceutical Microbiology Berlin, Germany October Visual Inspection Forum Berlin, Germany 6-7 November Pharmaceutical Freeze Drying Technology Spain 6-7 November 11 th Workshop on Monoclonal Antibodies Spain November Outsourcing & Contract Manufacturing Spain November Pharmaceutical Cold Chain & Supply Chain Logistics Spain Subject to change For latest info: europe.pda.org Shortlist 15 Nov 2017 Events with additional Education Program. More information europe.pda.org Connecting People, Science and Regulation General Information PDA Europe ggmbh Am Borsigturm Berlin, Germany Tel: Fax: europe. pda.org