Annex May 2018 Crowne Plaza Dublin Blanchardstown Dublin Ireland. Revision of the EU GMP Guideline. PDA Europe Workshop, Exhibition, Education

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1 PDA Europe Workshop, Exhibition, Education The Parenteral Drug Association presents: Annex 1 Revision of the EU GMP Guideline pda.org/eu/annex1_dublin 17 May 2018 Crowne Plaza Dublin Blanchardstown Dublin Ireland

2 OVERVIEW SCIENTIFIC PLANNING COMMITTEE Gabriele Gori, GlaxoSmithKline Vaccines, Chair Anil Busimi, SCHOTT Richard Denk, SKAN Aidan Harrington, DPS Engineering Ann McGee, PharmaLex Johannes Rauschnabel, Robert Bosch Miriam O Sullivan, Amgen Declan Quinlan, MSD Falk Klar, PDA Europe Sylvia Becker, PDA Europe, Manager Programs & Events The long-awaited draft of the revised Annex 1 has finally been released for discussion! The document s content has increased significantly and the industry is eager to see which formerly missing subjects have now been included. Possible clarification on various vague topics is also highly anticipated. A series of three conferences in Spain, Ireland and Germany will be set up by PDA Europe to cover the impact of these changes on the industry and on manufactures. Local authorities as well as industry speakers will present their views on the revised Annex 1 and the modifications it induces. The animated discussion arising will enable an extensive understanding of the new regulation. We look forward to welcoming you to this special PDA Europe event in Dublin! Gabriele Gori, PhD, GlaxoSmithKline Vaccines Workshop Chair 2 pda.org/eu/annex1_dublin

3 pda.org/eu/annex1_dublin 3

4 CONFERENCE AGENDA Thursday, 17 May Mar :00 Welcome & Introduction Falk Klar, PDA Europe Gabriele Gori, GlaxoSmithKline Vaccines Opening: Regulatory Update: Revision of Annex 1 Moderator: Gabriele Gori, GlaxoSmithKline Vaccines 9:10 Overview and Introduction into Final Draft EU GMP Annex 1 Greg McGurk, HPRA 9:40 Regulator s Perspective: Important Improvements and Developments 10:10 Industry s Perspective: Report on Comments prepared by PDA Task Force Beate Reutter, State Government Schleswig-Holstein Gabriele Gori, GlaxoSmithKline Vaccines 10:40 Q&A, Urgent Questions for Regulators 11:00 Coffee Break & Exhibition Session 1: Barrier Technologies Moderator: Declan Quinlan, MSD 11:30 Preventing Contamination and Cross Contamination Richard Denk, SKAN 11:45 Roundtable Discussion: Barrier Technologies All participants to discuss in small groups 12:30 Panel Discussion with Regulators & Industry Representatives 13:00 Lunch Break & Exhibition Session 2: Finishing of Sterile Products Moderator: Ann McGee, PharmaLex 14:00 Manufacturing of Sterile Products: Filtration, Fill & Finish and Sterilization Johannes Rauschnabel, Robert Bosch 14:15 Roundtable Discussion: From Filtration to Capping All participants to discuss in small groups 15:00 Panel Discussion with Regulators & Industry Representatives 15:30 Coffee Break & Exhibition Session 3: Primary Containers and CCIT Moderator: Miriam O Sullivan, Amgen 16:00 Visual Inspection and Container Closure Integrity Anil Busimi, SCHOTT 16:15 Roundtable Discussion: From Capping to Container Closure Integrity Testing All participants to discuss in small groups 17:00 Panel Discussion with Regulators & Industry Representatives 4 pda.org/eu/annex1_dublin

5 CONFERENCE AGENDA 17:30 Summary Remarks & End of Workshop Gabriele Gori, GlaxoSmithKline Vaccines Falk Klar, PDA Europe Don t miss the 3 PDA Europe Annual Meeting rd Global Healthcare of the Present & the Future Register by 29 April 2018 and SAVE! pda.org/eu/annual June 2018 Marriott Hotel Berlin Germany

6 PDA FLOOR PLAN Catering Air Wall to Conference 6 5 Air Wall Table Top 2 m x 3 m (6 m2) Catering PDA Registration TO E X H I B IT: PDA meetings and conferences are a great opportunity for your company to gain on-site exposure in front of highly-qualified, upper-level professionals in the pharmaceutical and biopharmaceutical industry. Exhibition and Sponsorship Opportunities are available. A basic exhibition package for this event is priced Euro net (table-top). For more information please contact expo-europe@pda.org 6 pda.org/eu/annex1_dublin

7 PDA Europe Conference, Exhibition, Education The Parenteral Drug Association presents: Pharmacopoeia Conference Convergence, Harmonization & The Future Direction of Pharmacopoeias Register by 8 April 2018 and SAVE! May 2018 Renaissance Wien Hotel Vienna Austria

8 INFORMATION VENUE Crowne Plaza Dublin - Blanchardstown Blanchardstown Town Centre Dublin 15 Ireland Tel: Special Rates PDA Europe has reserved a limited number of bedrooms until the 4 April Book your group rate for PDA. Single Room 155 per room and night Double Room 185 per room and night *Rates are per room and night, including 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. GENERAL ADDRESS PDA Europe ggmbh Am Borsigturm Berlin, Germany Tel: Fax: CONFERENCE REGISTRATION HOURS Thursday, 17 May: 8:00 12:00 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. DIRECTIONS CROWNE PLAZA DUBLIN - BLANCHARDSTOWN DUBLIN Google For directions click on the picture, scan the QR-code or go to 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 Exhibition / Sponsorship Inquiries Nadjeschda Gomez-Stahl expo-europe@pda.org 8 pda.org/eu/eventname2017

9 Annex 1 For contact at PDA Europe registration-europe@pda.org 3 WAYS TO REGISTER ONLINE: pda.org/eu/annex1_dublin FAX: registration-europe@pda.org This PDF-file provides an automatic fill-in function. Your signature, however, is needed in writing. 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. Information about Visa Matters 2 Registration 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). All fees given in Euro and excluding VAT (23 %) 3 Payment Options By Credit Card Workshop (17 May) All Participants 895 American Express MasterCard VISA For your credit card information safety: Please send your details by fax only ( ) or register online. By Bank Transfer Beneficiary: PDA Europe ggmbh IBAN: DE BIC (SWIFT-Code): DEUTDEDBBER Bank Address: Deutsche Bank, Welfenallee 3-7, D Berlin, Germany By Purchase Order Purchase Order Number 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. PDA Europe VAT I.D.: DE Billing Address: Your Company VAT I.D.: Same as contact information address above. If not, please send your billing address to: registration-europe@pda.org This number starts by your country code with two characters (example: PDA Europe s country code starts with: DE followed by the number) 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 us at registration-europe@pda.org. Other discounts cannot be applied. 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 excl. VAT per name change. REFUNDS: Refund requests must be sent to PDA Europe. If your written request is received on or before 5 April 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 registration-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/annex1_dublin 9

10 P D A E U R O P E E V E N T S 13 April Interest Group Meeting Visual Inspection IG Berlin, Germany April Vaccines Málaga, Spain 8-9 May Virus Forum Florence, Italy 17 May Annex 1 Dublin, Ireland May Pharmacopoeia Conference Vienna, Austria 5-6 June Advanced Therapy Medicinal Products Amsterdam, The Netherlands 25 June 25 June June Interest Group Meeting Quality Systems Interest Group Meeting Freeze Drying 3 rd PDA Europe Annual Meeting IG IG Berlin, Germany October Pharmaceutical Microbiology Berlin, Germany October Visual Inspection Forum Berlin, Germany 6-7 November Outsourcing & Supply Chain - A 360 View Seville, Spain 22 November Project Management in the Pharmaceutical Industry Challenges & Possibilities Berlin, Germany November Pharmaceutical Freeze Drying Technology Seville, Spain November 11 th Workshop on Monoclonal Antibodies Seville, Spain Subject to change For latest info: europe.pda.org Shortlist 20 Mar 2018 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: info-europe@pda.org europe. pda.org