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Parenteral Drug Association Connecting People, Science and Regulation ®

Particles in Injectables Conference - PDA Exchange

Sep 26 - Sep 27, 2017 |
Sep 27, 2017 |
Sofitel Berlin Kurfürstendamm | Berlin, Germany
  • Conference
  • Europe
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This year marks the 2nd edition of the conference on Particles in Injectables in Berlin from 26-27 September and the 10th Anniversary of PDA Europe's Monoclonal Antibodies Workshop. Follow the link for more information on the workshop. Both events will join forces as part of the PDA Exchange meeting format. This meeting format combines two meetings in the same place, allowing the audience to swap between the two meetings and attend different sessions with just one meeting ticket. This format gives you the chance to “Meet, Exchange and Connect” with colleagues, peers and professionals from different backgrounds around the globe.

The Particles in Injectables conference provides you with a summary of 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, impacting patient safety. A session will focus on the nature and sources of these particles in parenterals and in infusion sets used in clinical studies and hospitals. The difference between particles in drugs and clinical infusions will be highlighted. Furthermore, packaging materials, such as glass vials, syringes and rubber stoppers, are known to be major sources of particulate contamination. A session will discuss defects in packaging materials and strategies employed to detect and control them. And last but not least, manual inspection continues to provide the critical reference method for all compendial inspection activity. Therefore, the concluding session will look at the use of particle standards to qualify manual and automated inspection systems, control of critical inspection parameters, as well as the development of an inspection method.

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Tuesday, 26 September 2017

9:00
Welcome and Introduction
Kerstin Wilken, PDA Europe
Markus Lankers, rap.ID
John Shabushnig, Insight Pharma Consulting

Session 1: Regulatory and Pharmacopoeial Guidance on Particles in Parenterals

Moderator: Markus Lankers, rap.ID

Many different regulations govern the methods used to determine particles in parenterals and the limits associated with these methods. Some of these differences are regional and others are the result of varying interpretation of general guidelines. This session has been organized to provide current benchmarking and developments in this important element of the quality systems associated with parenteral medicines. This is also an excellent opportunity to discuss concerns and issues with current regulations.

9:15
Visible Particulates in Injections: A Regulatory Perspective
Stephen Langille, FDA

9:45
Unique Status of mAbs in Europe, Requirements for Injectable Products
Steffen Gross, PEI

10:15
USP Activities
John Shabushnig, Insight Pharma Consulting

10:45
Q & A, Discussion

11:00
Coffee Break, Poster Session & Exhibition

Session 2: Studies on Particles in Clinics, Sources of Particles

Moderator: John Shabushnig, Insight Pharma Consulting

Particulate matter, visible or subvisible, in sterile parenteral products is regarded a critical quality attribute, impacting patient safety. Particles can arise from many sources foreign, intrinsic, or inherent to the product. This session discusses the nature and sources of these particles in parenterals and tools used in the clinical environment e.g. infusions sets. The differences between particles in drugs and clinical infusions will be highlighted.

11:30
Application of Bedside Filtration – a Tool to Reduce Protein Aggregates Risks Dramatically
Benjamin Werner, Ludwig Maximilian University of Munich

12:00
Product Related Particles in Drugs and Infusion Sets
Markus Lankers, Rap.ID

12:30
Particulate Contaminants in Single-Use Systems: Measurement Challenges
Klaus Wormuth, Sartorius Stedim

13:00
Q & A, Discussion

13:15
Lunch Break, Poster Session & Exhibition

Session 3: Sources of Particles, Measurements, Particle Loads

Moderator: John Ayres, Eli Lilly

This session will include a review and discussion of particle types, sources, numbers and potential clinical impact. Measurement challenges and the impact of subvisible particles will be explored.

14:15
Linking Process Capability and Patient Risk to Establish SVP Acceptance Limits
John Ayres, Eli Lilly

14:45
Industry Approaches to Visible Particles
Hanns-Christian Mahler, LONZA

15:15
Requirements of Glass Quality of Primary Packaging Materials
Uli Löschh, Universitätsspital Basel

15:45
Q & A, Discussion

16:00
Coffee Break, Poster Session & Exhibition

Session 4: Panel Discussion on Pharmaceutical Manufacturing

Moderator: Markus Lankers, rap.ID

16:30
From the Perspective of a National Quality Reviewer
Martine Jequier, Swiss Medic

17:00
Panel Discussion

18:00
End of Day 1

19:00
Networking Dinner


Wednesday, 27 September 2017

Session 5: Medical Impact of Particles

Moderator: Roman Veillon, GlaxoSmithKline

9:00
Y-Site Compatibility of Intravenous Medications for Children
Patrick Ball, University of Wolverhampton

10:00
Coffee Break, Poster Session & Exhibition

10:30
Sepsis, Systemic Inflammatory Response Syndrome (SIRS)
Michael Sasse, Hannover Medical School

11:00
The Effect of In-Line Filtration to Reduce Systemic Inflammatory Response Syndrome
Oliver Baud, APHP

11:30
Interactions and Effect of Nanoparticles in the Healthy and Diseased Microvasculature
Markus Rehberg, University of Munich

12:00
Q & A, Discussion

12:30
Lunch Break, Poster Session & Exhibition

Session 6: Reducing Particle Load and Risk Mitigation, Improving the Patients Situation: Possible Strategies to Reduce Particle Load, e.g. Manufacturing, Use of Filters, Risk Assessment

Moderators:
Volker Luibl, PALL
Romain Veillon, GlaxoSmithKline

Clinical guidelines for healthcare providers regarding the risk mitigation of particles vary strongly from country to country or do not exist currently. In order to establish these guidelines, it is not only critical to quantify and qualify particles that may be infused in patients but also to evaluate the consequences within different clinical scenarios and patient profiles. Eventually a global consensus will lead to patient safety based on the outcome of these studies.

13:30
In-Line Filtration Reduces Postoperative Phlebitis: A Randomized Clinical Trial on Abdominal Surgical Patients
Gianluca Villa, University of Florence

14:00
How many Particles enter the Body during Infusion Therapy
Cornelia Keck, Philipps-University Marburg

14:30
Coffee Break, Poster Session & Exhibition

15:00
Are We Ready for Global Consensus on Filtration Practice?
Ton van Boxtel, WoCoVa

15:30
Closing Panel Discussion

Topics:

  • Many Aspects In-Line Filtration in Clinical and Pharmaceuticals
  • Qualifications of Filters

 

16:30
Farewell Remarks & End of Conference

4 Ways to register

Please remember to log in if you are a member of PDA already! 

If you come from a Governmental or Health Authority Institution or from an Academic Organization please contact Ms. Antje Petzholdt before registering. She will verify your status and register you.

  • 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).
  • No PDA membership obtainable upon booking training course, workshop or other related event.

Registration Fees

Are you entiteld to receive a discount? Need Help?

Member

By 30 July 2017
1,345 Euro

After 30 July 2017
1.495 Euro

Nonmember

By 30 July 2017
1.645 Euro

After 30 July 2017
1.795 Euro

Govern./Health Authority/Academic

By 30 July 2017
670 Euro

After 30 July 2017
750 Euro

All fees given in Euro and excluding VAT (7%)

Contact

Antje PetzholdtAntje Petzholdt
Manager Registration, Chapters & Membership
Tel: +49 (0) 30 43 655 08-10
Fax: +49 (0) 30 43 655 08-66
Email

Exterior

Sofitel Berlin Kurfürstendamm
Augsburger Strasse 41
10789 Berlin
Germany
Tel: +49 30 800 999 0
Fax: +49 30 800 999 99
Hotel Website
Email

Just 100m from the Kurfürstendamm Boulevard, Sofitel Berlin Kurfürstendamm has a strikingly modern architecture with its spacious rooms and suites featuring dark woods and high windows.

Restaurant Le Faubourg offers traditional French cuisine and an outdoor terrace overlooking Kurfürstendamm.

Formerly the Hotel Concorde Berlin, the Sofitel Berlin Kurfürstendamm provides a touch of luxury in an Art Deco building. It is near designer boutiques, cultural highlights, the KaDeWe department store, Berlin Zoo, the Theater des Westens, Charlottenburg Palace and the Deutsche Oper Opera House.

Kurfürstendamm Underground Station is just a 3-minute walk from the Sofitel. Buses run directly to Tegel Airport from there.

PDA Europe has reserved a limited number of rooms until the 17th August 2017.

for the PDA Group Rate.

Single Room € 165 per night*
Double Room € 185 per night*

*Rates are per room and night, including the following services and benefits:

  • Buffet Breakfast in the restaurant
  • Wireless Internet Connection (Wi-Fi)
  • On-site Parking
  • Taxes and Service will apply

How to Get There

Berlin-Tegel Airport - TXL
Airport Phone: +49 30 6091 1150
Hotel distance: 13 km

  • Bus service, fee: € 2.80 (one way)
  • Estimated taxi fare: € 26

Berlin-Schoenefeld International Airport – SXF
Airport Phone: +49 30 6091 1150
Hotel distance: 23 km

  • Bus service, fee: € 3.40 (one way)
  • Estimated taxi fare: € 48 

Photos

Sponsorship and Exhibit Opportunities are Available!

For more information about exhibit and sponsorship opportunities, please contact:

Nadjeschda Gomez-Stahl
Manager Exhibition & Sponsorship
Tel: +49 (0) 30 43 655 08-23
Fax: +49 (0) 30 43 655 08-66
Email

Register Now
https://store.pda.org/Meetings/Login.aspx?ID=3650

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