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CALL FOR ABSTRACTS
ABSTRACT SUBMISSION DEADLINE 15 APRIL 2019
2019 PDA EUROPE
Particles In Injectables
24-25 SEPTEMBER 2019 BERLIN, GERMANY
EXHIBITION: 24-25 SEPTEMBERTRAINING: 26-27 SEPTEMBER
pda.org/EU/particles2019
CONNECTINGPEOPLE SCIENCE AND
REGULATION®
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CONFERENCE OVERVIEW
• New developments in automated inspection technology
• Artificial intelligence and deep learning• Image processing software
4. TECHNOLOGY
Call for Abstracts Topics areas of interest will include but are not limited to the following
• Fundamental investigations into inspection processes
• Preparation and use of standards in assessing visual inspection processes
• Definition and classification of defects and the preparation of defect libraries
• Challenges of difficult to inspect products (lyophilized, suspensions, viscous solutions, large molecule, pre-filled syringes, flexible bags, etc.)
• Use of acceptance sampling and AQLs• Development and control of manual
inspection processes• Validation of particle reduction effec-
tiveness• Physical properties of drug products• Detection, measurement and response
2. INSPECTION PROCESS
• Particulate/Foreign material identifi-cation
• Contribution of packaging components to visible particles
• Foreign material sources in the man-ufacturing environment and their control
• Sub-visible particles• Investigation of unclear/unexplained
particles• Prior Knowledge and its accessibility
3. PARTICLE IDENTIFICATION AND SOURCE ANALYSIS
• Visual inspection process• Container closure integrity• EU GMP Guideline revision of Annex 1• Requirements for particles in pharma-
copoeias• Requirements for particles in medical
devices• Quality standards regarding particle
load in hospitals
1. REGULATORY UPDATES
Dear Colleagues,
On behalf of PDA Europe, we would like to invite you to submit a paper or poster abstract for presentation at the PDA Europe Particles In Injectables Conference, 24-25 September 2019 in Berlin, Germany!
Abstracts and posters must be non-commercial in nature, describing new developments or work that significantly contributes to the body of knowledge related to particles in injectables.
The Particles in Injectables conference aims to provide a conclusive summary of the most recent information on the risks to human health associated with particulate matter. Particles can arise from many sources: foreign, intrinsic, or inherent to the product. Particulate matter, visible or subvisible, in sterile parenteral products is regarded a critical quality attribute with the potential to impact patient safety. The conference will review the nature and the sources of particles in injectables and in infusion sets used in clinical studies, outpatient therapy and hospitals. The difference between particles in drug products and those found in clinical infusion sets will be examined. Packaging materials, such as glass vials, syringes and rubber stoppers are known to be major sources of particulate contamination. The use of particle standards to qualify manual and automated inspection systems, control of critical inspection parameters, as well as the development of reliable inspection methods will be highlighted.
This year, the conference will again be part of the PDA Europe Exchange Series, taking place in parallel to the conference on Pharmaceutical Freeze Drying Technology. Take advantage of this 2-for-1 deal and submit your abstract today!
We look forward to welcoming you to Berlin!
Sincerely,
John Shabushnig, PhD, Chair Insight Pharma Consulting
John Ayres, MD, Chair Pharma Safety Solution
pda.org/EU/particles2019
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INFORMATION
• Special considerations for the inspection and handling of biopharma-ceuticals
• Detection and characterization of protein aggregationto
• How to inspect Cell and Gene thera-peutics
5. INSPECTION OF BIOPHARMACEUTICALS
• Clinical impact / patient risk of particles
• Long-term vs. short-term clinical impact of particles
• Risk assessment for products using different injection routes (intramuscular, subcutaneous, intrave-nous, intraocular, etc.)
• Risk caused by sub-visible particles• Measures to prevent particle intake • Therapeutic particles• Classification of patient groups at risk
for harm by particles• Clinical risk assessment vs. patient
risk assessment• Impact of particles on tissue function
and the immun system• How to select inline filters • Long-term vs. short-term clinical con-
sequences of particles in patients
• Particulate or defect control and inspection
• Validation of automated inspection systems
• Process of eyesight check for human inspectors
• Selection and training of human inspectors
• Two-step inspection process• Reconstitution for administration
• Advancements in drug delivery sys-tems and devices and their impact on particle risks
• Interactions of drug product and components
• Risks and benefits of different drug delivery systems
• How are drug products influenced on the delivery path?
6.CLINICAL IMPACT OF PARTICLES
7.CASE STUDIES 8.MEDICAL DEVICES AND DRUG DELIVERY SYSTEMS
SCIENTIFIC PROGRAM PLANNING COMMITTEEJohn Shabushnig, Insight Pharma Consulting, Chair
John Ayres, Pharma Safety Solution, Chair
Ton van Boxtel, WoCoVA
Cornelia Keck, University Marburg
Paul Kinsey, GSK
Stephen Langille, Valsource
Markus Lankers, MIBIC
Volker Luibl, PALL
Klaus Wormuth, Sartorius Stedim
Falk Klar, PDA Europe
Teresa Schubach, PDA Europe, Manager Programs & EventsVENUEMarriott BerlinInge-Beisheim Platz 1Berlin, GermanyTel: + 49 (0) 30 22 00 00https://goo.gl/aYH4BS
Call for Abstracts Topics areas of interest will include but are not limited to the following
pda.org/EU/particles2019
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POSTER SESSION
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Pharmaceutical Freeze Drying Technology
Particles in Injectables
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PDA Registration
Poster Session
To reserve your space, please [email protected] or via telephone + 49 30 436 55 08 10.
pda.org/EU/particles2019
CANVASYour
Poster Design here
85 cm x 120 cm(33,465 in x 47,244 in)
Your Logo here
20 cm (7,875 in)
max high 20 cm (7,875 in)
206 cm (81,1024 in)
PDA Scientific Poster PresentationExhibit your Work
Canvas size to work on:85 cm x 120 cm (33,465 x 47,244 in) – portrait formatSlug / Bleed: 2 mm (0,079 in)
Images: 120dpi (low) - 150dpi (high) depending on size.All Images Color Profile ISO Coated v2 (ECI)
Document size of the PDF:85 cm x 206 cm (33,465 x 81,102 in) – portrait formatSlug / Bleed: 2 mm (0,079 in)
All posters will be printed by PDA and displayed as part of the exhibition.
Poster Display is included in the regular conference registration fee. Please send your file and poster title toKerstin Wilken [email protected].
To join our scientific poster session, please send a printable PDF file according to the following specifications:
Deadline:
9 August 2019
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Registration
Your registration is only complete upon filling in and submitting both pages of this form.
Please mark here if your company is an exhibitor to this event and you will receive the conference ticket at the special price of 1195 € per ticket. No further discounts are applicable with this option (as PDA Membership Discount or Group Ticket discount).
Discount for Exhibiting Companies
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 [email protected]. Other discounts cannot be applied.
The fee includes event 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.
Book by 28 July 2019 to receive € 200 off the conference fee only
All fees given in Euro, tax exempt in Germany
EARLY BIRD DISCOUNT
26 September One-Day Training Course Training Course Fee
Freeze Drying for Advanced Users - A Risk-based Approach All Participants 895
26-27 September Two-Day Training Course Training Course Fee
Development of a Freeze Drying Process All Participants 1595
26-27 September Two-Day Training Course Training Course Fee
An Introduction to Visual Inspection: A hands-on course All Participants 1595
26-27 September Two-Day Training Course Training Course Fee
Mastering Automated Visual Inspection All Participants 1595
Reg Form Page 1
24-27 September 2019 | Berlin | Germany
**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).
Your consent is important. We manage your personal data responsibly.For more information, please visit pda.org/privacy-policyRESPONSE REQUIRED – By checking the box(es) below, I consent to:
My contact information (name, company, job title, city, state, country) being printed on the attendee list distributed at the event.
PDA sending me promotional information via email.
PDA recording and/or photographing me and using those recordings and/or photographs in future PDA promotional and marketing materials.
PDA sending me promotional information via post
Join PDA and receive the Membership Rate Today!Please got to:pda.org/membership
PDA Europe Conference Registration
124-25 September 2019 Conferences
Particles In Injectables Pharmaceutical Freeze Drying Technology
As part of the PDA Exchange meeting format, you can attend the two meetings with just one ticket
Conferences Fee
PDA Member 1695 **Nonmember 1995 Young Professionals*
850 Regulatory/ Academic**
850* Early Bird 750 €
Poster Presenter please mark here (written approval required, conference fee applies)
*Rate applicable to all professionals 30 years of age or younger. A proof via ID or Passport copy is required, please submit this via fax or e-mail. Rate does not include membership. Further discounts as of Early Bird and Group Discount are not applicable to this rate.
This PDF-file provides an automatic fill-in function. Your signature, however, is needed in writing.
pda.org/EU/particles2019
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online: pda.org/EU/particles2019FAX: + 49 30 436 55 08-66Email: [email protected]
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Date Mandatory Signature
Your registration is only complete upon filling in and submitting both pages of this form.
Billing Address: Same as contact information address above. If not, please send your billing address to: [email protected]
By Purchase Order
Purchase Order Number
Reg Form Page 2
24-27 September 2019 | Berlin | Germany
Information about Visa Matters • 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 submit-ting 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).
Payment Options
By Bank Transfer Beneficiary: PDA Europe gGmbHIBAN: DE73 1007 0024 0922 8735 00BIC (SWIFT-Code): DEUTDEDBBERBank Address: Deutsche Bank, Welfenallee 3-7, D-13465 Berlin, Germany
By Credit Card
American Express MasterCard VISAFor your credit card information safety:Please send your details by fax only (+ 49 30 436 55 08-66) or register online.
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.: DE254459362
PDA Europe Conference Registration
3 WAYS TO REGISTER
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If this form is an update to a previously submitted form, please check here.
Mr. Ms. Dr. NonmemberI want to become a PDA Member. Please send me a subsription form
Job Title
Mailing Address
Substituting for(Check only if you are substituting for a previously enrolled colleague; a nonmember substituting for member must pay the membership fee.)
Your Contact Information
PDA MemberName (Last, First, MI)
ID Number
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FaxBusiness Phone
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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 25 August 2019 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 [email protected] or fax to + 49 30 436 55 08-66.
This PDF-file provides an automatic fill-in function. Your
signature, however, is needed in writing.
pda.org/EU/particles2019
DeadlinesAbstracts of Papers for Presentation: 15 April 2019Poster abstracts: 9 August 2019If you have any further questions, please do not hesitate to contact [email protected]
All submitted abstracts will be reviewed by the Scientific Program Planning Committee for acceptance. PDA Europe will provide one complimentary registration per podium presentation. Additional presenters and poster presenters are required to pay appropriate conference registration fees. Abstracts not selected for a 30-minute podium presentation may be invited to join as a scientific poster contribution.
https://goo.gl/BhmZbV
THE ONLINE PROCESS ASKS YOU TO PROVIDE THE FOLLOWING INFORMATION:- PRESENTATION TITLE
- PRESENTER’S NAME AND CONTACT DETAILS
- PRESENTER’S BIOGRAPHY (APPROX. 100 WORDS)
- ADDITIONAL SPEAKERS (IF APPLICABLE)
- KEY OBJECTIVES OF TOPIC
- 2-3 PARAGRAPH ABSTRACT, SUMMARIZING THE TOPIC
Please click or scan the QR Code to submit your abstract.
To Exhibit:PDA is seeking vendors who provide products/services in support of this conference. Space is limited and is on a first-come, first-serve basis. To reserve your space, please contact [email protected] or via telephone + 49 30 436 55 08 10.
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SUBMISSION PROCESS
pda.org/EU/particles2019
