The Parenteral Drug Association presents:

2017 PDA Europe

Pharmaceutical Microbiology Microbiology in Pharmaceutical Manufacturing

CALL FOR PAP ERS & POSTE RS

Deadline for Abstracts 30 September 2016

14-15 February 2017 Porto | Portugal

LETTER FROM THE CHAIR Dear Colleagues, On behalf of the program planning committee, we are delighted to invite you to attend the PDA Europe 8th Conference on Pharmaceutical Microbiology, to take place in Porto, Portugal on 14-15 February 2017. SCIENTIFIC PROGR AM PL ANNING COMMIT TEE

1 Michael Miller, Microbiology Consultants 2 Heike Merget-Millitzer, Janssen Cilag 3 Jeanne Moldenhauer, Excellent Pharma Consulting 4 Paul Newby, GSK 5 Johannes Reich, University of Regensburg 6 Marsha Stabler Hardiman, ValSource 7 Anil Sawant, Merck & Co. 8 Sylvia Becker, PDA Europe 9 Falk Klar, PDA Europe

Next year’s conference theme will be “Microbiology in Pharmaceutical Manufacturing” and a comprehensive scientific program will include presentations from regulatory, industry and technology representatives from around the world. The conference program is tailored to addressing the current issues and opportunities our industry faces every day. For example, topics of interest can include how to maintain process water systems to prevent contamination and biofilms, how to validate new technologies and microbiological methods, prevention of contamination in sterile and non-sterile products and of course, new trends in endotoxin testing.

In addition, the following new sessions will be included to provide even more opportunity for addressing key issues on a face-to-face basis: 2

• PDA Challenge Summit: Where attendees participate in teams to understand industry challenges and offer solutions. • PDA INTERACTIVE: You will engage industry experts in controversial topics of interest. • Focus Topic: Maintaining Pharmaceutical Grade Water Systems and contamination control. Of equal importance to the content is to interact with the speakers and your fellow attendees. Morning and afternoon refreshment breaks will offer occasions to visit the exhibitors and to meet with other industry and regulatory microbiologists. On-site luncheons and evening receptions will also provide ample networking and discussion opportunities. The planning committee is working diligently in making this conference relevant to the most important microbiological challenges our industry is facing today. We look forward to welcoming you to an informative, engaging, thought provoking and enjoyable conference. Come join us in our new and exciting venue, Porto, Portugal! Sincerely,

Michael J. Miller, PhD, Microbiology Consultants, LLC, PDA Europe Conference Chair

INFORMATION

Welcome to Porto! VENUE Hotel Porto Palácio Av. da Boavista 1269 4100-130 Porto Portugal

T O E X H I B I T: 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 highly-qualified, 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 the attendees.

Who Should Attend Departments | Microbiology, Compliance, Engineering, Manufacturing, QA/QC, CMC Documentation, Regulatory Affairs, Research and Development, Validation, QP Level of Expertise | Senior Subject Matter Expert, Management, Scientists/Technicians Job Function| Supervisor, Researcher, Analyst, Operative Personnel

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C A LL FOR PA PERS & POS TERS

We would like to invite you to submit a paper or poster abstract for presentation a PDA Europe Conference on Pharmaceutical Microbiology in Porto, Portug

PDA CHALLENGE SUMMIT Sharing Industry Challenges and Solutions Teams of solution providers and pharma companies share key issues, technological developments, bestpractice approaches and possible solutions for implementation and routine application.

Focus Topic: Pharmaceutical Grade Water

Water syst mainte ▼ Production o ceutical Gra ▼ Valida

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General Topics

Keynote Presentations

Describing the latest developments, trends and future perspectives by Academia, Industry and Regulatory Agencies • • • •

New Technologies & Trends Rapid Micro Methods Quality Metrics Data Integrity

• • • • • • •

Sterile / Non-Sterile Products Quality Risk Assessment Control Strategy Raw Materials Microbial Challenges Objectionable Organisms Endotoxins and Pyrogens

• • • • • •

Aseptic Process Container Closu Environmental Quality of Produ Single-Use Syst Media Fills

REGULATORY PERSPECTIVES

Presenting current & future regulatory guidelines, approaches, expectations and findings by international inspectors and assessors.

at the gal on 14-15 February 2017

tems and enance ▼ of Pharmaade Water ▼ ation

ASK THE REGUL ATOR

Testing methods ▼ Remediation ▼ Biofilms

This is a unique platform to share on-the-job issues* and receive advice from regulators as well as from your peers! *Submit your sensitive questions to PDA in advance to be addressed here.

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PDA INTERACTIVE:

sing ure Integrity Monitoring uct tems

Knowledge meets Discussion Committee members and selected speakers will facilitate lively discussions and exchange around a choice of controversial key issues. Feedback will be collected and shared as a summary at the end of the day.

• Annex 1 Revision • Recent Trends & Inspectorial Findings • Application of New Pharmacopoeia: Compounding in EU vs. US • Compendial Strategies

• • • • •

Regulations and Submissions Emerging Markets Harmonization Efforts & Challenges Satisfying Global Regulatory Requirements Meeting Pharmacopoeial Expectations

INFORMATION HEADERHEADLINE

Paper abstracts must be non-commercial in nature, describing new developments or work that significantly contributes to the body of knowledge relating to pharmaceutical microbiology. Abstracts not selected for a 30 minute podium presentation may be invited to join as a scientific poster contribution. All submitted abstracts will be reviewed by the Scientific Program Planning Committee for acceptance.

A BS TR AC TS MUS T INCLUDE:

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- TOPIC / TITLE

- PHONE NUMBER

- MAIN PRESENTER‘S NAME*

- FAX NUMBER

- PRESENTER’S BIOGRAPHY (APPROX. 100 WORDS)

- E-MAIL ADDRESS

- ADDITIONAL AUTHORS

- ABSTRACT, SUMMARIZING YOUR TOPIC

- POSTAL MAILING ADDRESS

- KEY OBJECTIVES OF YOUR TOPIC

Abstracts must include all requested information to be eligible for selection.

Deadlines Abstracts of papers for presentation: 30 September 2016** Poster abstracts: 17 October 2016

PLEASE CLICK HERE TO SUBMIT YOUR ABSTRACT

* One speaker per podium presentation participates free of charge. All additional presenters will be subject to a registration fee. **A more detailed draft presentation will be due for committee review one month prior to the conference to ensure scientific nature of content

Attention Exhibitors PDA is seeking vendors who provide products/services in support of this conference. Space is limited and is on a first-come, first-served basis. To reserve your space, please contact Creixell Espilla-Gilart, [email protected] or via telephone +49 30 4365508-14

The Parenteral Drug Association presents:

2016 PDA Europe

Outsourcing & Contract Manufacturing 14 November Managing Single- and Multi-Source Supply Chain Challenges 17 November Quality by Design for Biopharmaceuticals

Register by 15 Oct 2016 and SAVE!

pda.org/EU/Outsourcing2016

17-18 November Practical Guide for Root Cause Investigations 17-18 November Outsourcing, Technology Transfer, and CMO-Client Relationships

17-18 November Risk Management in Technology Transfer 17-18 November Basics of Successful Auditing

15-16 November 2016 Olivia Balmes Hotel Barcelona | Spain

2016 PDA EUROPE ACTIVITIES & EVENTS 8-9 November

Data Integrity

WS

14 November 15-16 November 17 November 17-18 November 17-18 November 17-18 November 17-18 November

Managing Single- and Multi-Source Supply Chain Challenges Outsourcing & Contract Manufacturing | Conference Quality by Design for Biopharmaceuticals Practical Guide for Root Cause Investigations – Methodology & Tool Kit Outsourcing, Technology Transfer, and CMO-Client Relationships Risk Management in Technology Transfer Basics of Successful Auditing

TC

24-25 November

Track und Trace-Implementierung von Serialisierung

TC

TC WS TC TC WS

Berlin, Germany

Barcelona, Spain

Leipzig, Germany

2017 PDA EUROPE CONFERENCES 14 – 15 February 16 – 17 February 16 – 17 February

Pharmaceutical Microbiology Rapid Microbiological Methods TC Practical Guide for Root Cause Investigations – Methodology & Tool Kit TC

Porto, Portugal

14 – 15 March

Parenteral Packaging

Barcelona, Spain

26 – 27 April

Current Trends in Aseptic Fill & Finish of Prefilled Syringes

Ravensburg, Germany

30 May – 1 June

Virus & TSE Safety Forum

Dubrovnik, Croatia

13 – 14 June

2nd PDA Europe Annual Meeting

Berlin, Germany

27 – 28 June

Advanced Therapy Medicinal Products

Valencia, Spain

19 – 20 September Pharmaceutical Freeze Drying Technology

Cologne, Germany

26 – 27 September 10 th Workshop on Monoclonal Antibodies

Berlin, Germany

10 – 11 October

Pharmaceutical Cold & Supply Chain Logistics

Rotterdam, Netherlands

7 - 8 November

The Universe of Pre-filled Syringes and Injection Devices

Vienna, Austria

21 – 22 November

Outsourcing & Contract Manufacturing

Lisbon, Portugal

Subject to change

For latest info: europe.pda.org

Shortlist 31 Oct 2016

General Information PDA Europe gGmbH Am Borsigturm 60 13507 Berlin, Germany Tel: +49 30 4365508-0 Fax: +49 30 4365508-66

Conference Information Melanie Decker Director Events & Exhibitions Tel: + 49 30 4365508-19 [email protected]

Training Course Information Elke von Laufenberg Manager Training & Education Tel: + 49 30 4365508-21 [email protected]

Legend IG – Interest Group Meeting TC – Training Course WS – Workshop www.europe.pda.org