2017 PDA Europe Events Brochure

2017

PDA EUROPE EVENTS

CO N T IN U E YO U R J O U R NE Y...

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TABLE OF CONTENTS Page

Content

Date

3

Wecome to PDA Europe

4

10 Years of PDA Europe

6

PDA Conference Formats – New Ways of Interaction

8

Pharmaceutical Microbiology – Welcome to Porto

14 – 15 February

10

Parenteral Packaging – Welcome to Barcelona

14 – 15 March

12

PDA Exchange Series 03/17 – Welcome to Berlin

20 – 23 March

14

Current Trends in Aseptic Fill & Finish of Pre-filled Syringes – Welcome to Lindau 26 – 27 April

16

Virus & TSE Safety Forum – Welcome to Dubrovnik

30 May – 1 June

18

2nd PDA Europe Annual Meeting – Welcome to Berlin

13 – 14 June

20

Advanced Therapy Medicinal Products – Welcome to Valencia

27 – 28 June

22

Pharmaceutical Freeze Drying Technology – Welcome to Cologne

19 – 20 September

24

PDA Exchange Series 09/17 – Particles and Injectables – Welcome to Berlin

26 – 27 September

26

PDA Exchange Series 09/17 – Monoclonals Antibodies – Welcome to Berlin

26 – 27 September

28

Pharmaceutical Cold & Supply Chain Logistics – Welcome to Prague

10 – 11 October

30

The Universe of Pre-filled Syringes and Injection Devices – Welcome to Vienna

7 – 8 November

32

Outsourcing & Contract Manufacturing – Welcome to Munich

21 – 22 November

34

PDA Education Program

38

Why Exhibit at a PDA Event

2

For latest info: pda.org/pda-europe twitter.com/pdaonline

Subject to change

twitter.com/PDA_Europe

LinkedIn.com/company/PDA

... with our 2017 Events in Europe “Change is the only constant”. This wisdom by Heraclitus well describes the many changes in today’s politics and society.

PDA has been changing throughout the past 60 years since its inception in 1946. A milestone in this development was the establishment of PDA Europe in 2006.

PDA stands for “Connecting People, Science and Regulation”.

To meet that need, PDA Europe has developed new and engaging conference formats like “PDA Interactive” and the “PDA Challenge Summit” (p. 6-7), which have been designed to expand your network and exchange knowledge with other attendees. The new “PDA Europe Exchange Series” 2017 (p.13; 24-27) integrates Conferences, Trainings and various Interest Group Meetings under one roof, offering its participants the opportunity to engage in different scenarios while attending one single event to “Meet, Exchange and Connect”, not only with colleagues and peers, but with professionals from different backgrounds around the globe.

At the 14th Universe of Pre-Filled Syringes, we look forward to introducing you to a new show concept in the exhibition area.

The 2017 Education Program presents various training courses with revised content, together with completely new ones. For example, PDA Europe holds a new course on auditing, which combines communication skills with GMP knowledge and will be delivered by both a psychologist and a GMP expert (page 34).

In 2016, we were able to welcome more than 3.200 participants from 47 countries to our conferences, workshops and training courses. All events in 2017 will once more provide you with a variety of opportunities to exchange and network with representatives of international authorities and organizations, industry experts, suppliers as well as universities and research institutions.

This year, our events will focus on presenting new perspectives on innovative technologies, updates on regulatory changes and give you practice-oriented expert advice.

The team at PDA Europe is looking forward to welcoming you to our events in 2017!

Georg Roessling, PDA Europe

Falk Klar, PDA Europe

Georg Roessling, PhD General Manager, Senior Vice President PDA Europe roessling@pda.org

Falk Klar, PhD General Manager, Vice President PDA Europe klar@pda.org

Dirk Stelling Director, Finance & Administration stelling@pda.org

Melanie Decker Director, Events & Exhibitions decker@pda.org

Sylvia Becker Manager, Programs & Events becker@pda.org

Nadjeschda Gomez-Stahl Manager, Exhibition & Sponsorship gomez@pda.org

3

Creixell Espilla-Gilart Manager Marketing espilla@pda.org

Elke von Laufenberg Manager, Training & Education laufenberg@pda.org

Julie Tchuya Coordinator Program & Events tchuya@pda.org

Antje Petzholdt Manager Registration, Members, Chapters petzholdt@pda.org

Iryna Funke Registration Coordinator funke@pda.org

10 YEARS OF PDA EUROPE Established in 2006, it coordinates the association´s activities from its office in Berlin, Germany.

CONFERENCE 9 4 6

1590%

OL R P 1 HI S E ER C

‘06

205

L D RU G A S S

O

IO T A CI NTE R A

ou

nd

th

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or

ld

PAR E

64%

More n

sa

ATTENDEES

Back in 2006, PDA Europe started out with 205 attendees in its first year. Since then, the number of participants per year has not only doubled but risen to 3.257, which is a plus of 1590 percent. PDA events - the place to meet professionals working in the pharma- and biopharma sectors.

OF PDA M EMBERS HOLD

b t h a n 10. 0 0 0 M e m

ers

RL O I N A SE

EA

D

IN S N

E

ou 6C 7 >

e tri

3.257

‘16

r

* The data provided represents a conservative estimate

EXHIBITION ‘16 ‘06

800%

279

COMPANIES

35

Since 2006, the number of exhibiting companies at PDA Europe events has increased tremendously, making PDA Europe conferences a well-rounded experience where to stay informed about current trends and connected with all developments in the industry.

Members Europe 2016

CO

55%

2.175

22% of the total global membership

* E C N E R E NF

TRAINING ‘16

B ITI

20 %

O N*

STUDENTS

25

PDA Europe has built an impressive Education Program over the past years and can now welcome more than 500 students per year to a wide range of insightful and unique training courses, especially around GxP themes.

%

T

501

25

HI

RA

EX

IN I

NG *

‘06

2000%

5

47 COUNTRIES Regulators

More than 640 organizations, companies and academic institutions from 47 countries have attended events in Europe since 2006.

CONTINUE

THE

PDA EUROPE

HISTORY

Industry

Academics

PDA CONFERENCE FORMATS – NEW WAYS OF INTERACTION

PDA CHALLENGE SUMMIT

Joint Presentations of Innovation and Cooperation This unique format gives speakers the chance to team up and present industry challenges while showcasing a solution's approach. Selected experts, suppliers and end-users hold co-presentations and explain how they were able to cooperatively solve a challenge important to the industry. Attendees of the con­ference will be able to listen to how the co-speakers addressed issues associated with their fields of expertise. This format gives everyone a chance to discuss innovation and novel approaches. The PDA Challenge Summit is an integral part of selected conferences in 2017. If you are interested in submitting a “Challenge Summit” proposal, please send an email to programs-europe@pda.org 6

INDUSTRY

SUPPLIER

PDA CONFERENCE FORMATS – NEW WAYS OF INTERACTION

PDA INTERACTIVE

Knowledge Meets Discussion

Put your running shoes on because this interactive session will keep your mind and body in motion! Engage in roundtable discussions, where participants move between each debate every 30 minutes.

Committee members and selected subject matter experts facilitate lively discussions and informative exchange around several controversial key issues that are based on the respective conference theme. Each moderator prepares a short summary of the discussions and presents it to the audience at the end of the day.

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KEY ISSUE 1

KEY ISSUE 2

KEY ISSUE 3

GREEN GROUP

RED GROUP

BLUE GROUP

RED GROUP

BLUE GROUP

GREEN GROUP

BLUE GROUP

GREEN GROUP

RED GROUP

PDA HEADERHEADLINE Europe Conference, Exhibition, Education

Pharmaceutical Microbiology Including the latest global updates on data integrity, contamination control and aseptic processing

8

14-15 February 2017 Porto | Portugal

WELCOME TO PORTO This year’s conference in Porto, Portugal on 14-15 February 2017 will focus on “Microbiology in Pharmaceutical Manufacturing” and a comprehensive scientific program will include presentations from regulatory, industry and technology representatives from around the world. The program of the 11th Conference on Pharmaceutical Microbiology is tailored to address the current issues and opportunities our industry faces every day. The topics include: Validation of 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 meeting formats will be included to provide even more opportunity for addressing key issues on a face-to-face basis: • PDA Challenge Summit: Where one supplier and one manufacturer co-present an industry challenge they faced together, and its corresponding solution.

• PDA Interactive: Where attendees engage in rotating discussions with industry experts in controversial topics of interest.

9 AREAS AND TOPICS OF INTEREST

Hotel Porto Palácio Av. da Boavista 1269 4100-130 Porto | Portugal Tel +351 226 086 600 Fax +351 226 091 467 hotelportopalacio.com/en

Microbiology | Compliance | Engineering | Manufacturing | QA/QC | QP | CMC | Documentation | Regulatory Affairs | Research and Development | Validation

Education Program Available

VENUE

For registration and further information: pda.org/pharmaceutical-microbiology2017

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Parenteral Packaging

All Pharmaceutical Packaging Topics in one Conference

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14-15 March 2017 Barcelona | Spain

WELCOME TO BARCELONA PDA Europe’s Conference has proven to be a must-attend event for professionals in the Parenteral Packaging arena. Join us in Barcelona/Spain, 14-15 March 2017 to continue and further deepen scientific advancements and our ongoing professional discourse of latest on primary packaging technologies and business trends. The container closure system is crucial for the quality and the stability of the drug. This conference and the accompanying exhibition address quality of components and containers, container closure development and integrity testing as well as aspects of processing, product distribution and storage.

40 speakers from the industry, regulatory, suppliers and academia will give detailed information about opportunities and challenges the ever advancing pharmaceutical packaging market faces every day - and beyond. The conference aims to keep attendees updated about all technical and regulatory aspects involved in the parenteral packaging process. Hear about container closure integrity, the USP monograph <1207> and voices from the industry about it. See the latest on materials of components and containers and their characteristics and supplier issues. Learn about the power of modelling and simulation to shorten development time for container closure systems, pop-out phenomena and challenges of cryogenic storage. New capping solutions will be presented. Discuss in how to avoid creation of defects in the fill & finish process and how to reduce the particles load in stopper processing. And last but not least, the Packaging Science Interest Group will meet and share their program at the conference.

AREAS AND TOPICS OF INTEREST VENUE

Hotel Porta Fira Plaza Europa, 45 08908 â&#x20AC;&#x201C; Hospitalet de Llobregat, Barcelona, Spain Tel: +34 93 297 35 00 hotelbarcelonaportafira. com/en/

Container Closure Integrity | Test Methods | Extractables & Leachables | Cryogenic Packaging Solutions | Primary Packaging Processing | Container Handling | Drug-Device Process Development | Labelling Secondary Packaging | Quality Control Aspects Compliance | Audits

Education Program and Pre-Conference Workshop available For registration and further information: pda.org/eu-parpack-2017

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PDA Europe Conference, Exhibition

PDA Europe Exchange Series 03 / 17 Meet, Exchange and Connect 20 March Particle Identification in Parenterals

21 March IG Meeting Visual Inspection and Freeze Drying Technology

22 â&#x20AC;&#x201C; 23 March An Introduction to Visual Inspection

BUY ONE MEETING TICKET ATTEND TWO!

20-23 March 2017 Berlin | Germany

WELCOME TO BERLIN Welcome to the PDA Europe Exchange Series 03/17. This is a new format PDA Europe has developed to give you the chance to “Meet, Exchange and Connect” not only with colleagues and peers, but professionals from different backgrounds around the globe.

For the Exchange Series 03/17, taking place from 20-23 March in Berlin, the Interest Groups Visual Inspection and Freeze-Drying Technology will take place on the same day, just like in 2016, offering a single joint opening session for both groups.

This opening session will address shared issues as well as propose possible solutions.

After the lunch break, the group will be split in two and the meeting will continue in separate afternoon sessions, each one focusing in the specific topics of the respective Interest Group.

The following Education Program presents a variety of courses: starting with the “Particle Identification in Parenterals“ training course. This is a one-day comprehensive course taught by industry leading experts. Held at the rap.ID Particle Systems company premises, the course proposes strategies for the implementation of a cost-effective control through mandatory compliant root-cause investigations.

The week will be concluded with one of PDA’s most demanded training courses “An Introduction to Visual Inspection”: this is a hands-on training course that covers the fundamentals of visual inspection methods and their application to injectable products.

Steigenberger Hotel Berlin Los Angeles Platz 1 10789 Berlin, Germany Tel: +49 30 2127-0 reservations@berlin. steigenberger.de

VENUE

Education Program Available

For registration and further information: pda.org/eu/exchange-03

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PDAHEADERHEADLINE Europe Conference, Exhibition, Education

Current Trends in Aseptic Fill & Finish of Pre-filled Syringes A Look Inside Modern Aseptic Manufacturing

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26-27 April 2017 Lindau (Bodensee) | Germany

WELCOME TO LINDAU The conference is held from 26 -27 April in Lindau/Bodensee (Lake Constance) in Germany and presents a broad overview of current best practices in aseptic processing, with a focus on fill & finish for pre-filled syringes, including the current technical and regulatory trends. The first day starts with quality culture and metrics topics and how to integrate these into the manufacturing environment of today and tomorrow. Industry 4.0 and the impact of digitalization and barrier technology are further topics.

In the afternoon, there will be a site visit at Vetter in Ravensburg to see aseptic manufacturing and packaging for syringes. In parallel, there will be a workshop on the future of aseptic manufacturing, including ready-to-use concepts, RABS and isolator technology. The second day will open with a presentation by a GMP inspector, who will share insights from inspections, followed by first thoughts about the new EU GMP Annex 1 draft. Further presentations will focus on innovations in aseptic processing, and the conference will be concluded with a presentation on devices and the assembly of syringes into devices. The conference will provide an overall picture of aseptic processing and handling of pre-filled syringes.

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VENUE

AREAS AND TOPICS OF INTEREST

Microbiology | Validation | Quality | Regulatory | Sterility Assurance | Sterile Operations | Product and Process Development | GMP Services | Regulatory Affairs | Manufacturing | Formulation | Compliance | Engineering | QA/QC | Process Design | Research and Development |Technical Operations

Hotel Bayerischer Hof Seepromenade Bahnhofplatz 2, 88131 Lindau, Germany Tel +49 8382 9150 bayerischerhof-lindau.de

For registration and further information: pda.org/eu-fillfinish2017

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PDA Europe Conference, Exhibition, Education

Virus & TSE Safety Forum Updating you on Regulatory Expectations and Scientific Investigations on Virus and TSE Safety of Biotechnology, Plasma-derived and Cell-derived Medicinal Products.

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30 May â&#x20AC;&#x201C; 1 June 2017 Dubrovnik | Croatia

WELCOME TO DUBROVNIK The first PDA Europe Virus & TSE Safety Forum was established in 2001 and since then, it has been held annually, alternating between Europe and the U.S. These truly global meetings are organized under the leadership of PDA in close cooperation with European regulatory agencies and the U.S. FDA. The Forum provides an overview and updates on regulatory expectations and scientific investigations related to virus and TSE safety of biotechnology, plasma-derived and cell-derived medicinal products. One recurring topic to be set for discussion in the upcoming edition will be virus contamination of raw materials, as well as emerging viral threats. A further topic of this year’s edition will be appropriate risk mitigation strategies consisting of two elements: a) Testing and processing of raw materials and b) Virus removal/inactivation capacity of the processes used for production of medicinal products. The last day of the conference will focus on TSE and how much vCJD or BSE currently pose a threat to the safety of medicinal products. This year´s Forum, held at Dubrovnik from 30 May till 1 June, provides a unique opportunity for interactive discussion and benchmarking to all professionals working in the field. Exchange of information between industry and regulators will improve the understanding and acceptance of new techniques, highlight new and emerging risks and explain new regulatory approaches. Join us in vibrant Dubrovnik, a World Heritage Site on the Adriatic Sea, rich in history and culture, for a lively debate and networking!

AREAS AND TOPICS OF INTEREST API Development & Production | Pharmaceutical Development and Production | Process Engineering | Process Development | QC & QA | Container Development | Quality Control Production & Manufacturing | Information Services | Technology/Information Systems | Project/Facility Engineering | Manufacturing Process/ Packaging | Marketing/Sales | Consulting

Education Program and Pre-Conference Workshop available

VENUE

Sheraton Dubrovnik Riviera Hotel Šetalište Dr. Franje Tudmana 17 Srebreno, Mlini, 20207 Dubrovnik, Croatia Tel: +385 20 601 500 sheratondubrovnikriviera. com

For registration and further information: pda.org/eu-virus2017

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2nd PDA Europe Annual Meeting Global Healthcare of the Present & the Future

13-14 June 2017 Berlin | Germany

WELCOME TO BERLIN After the tremendous success of the first PDA Europe Annual Meeting, we look forward to the second edition of this conference in Berlin, Germany, 13 â&#x20AC;&#x201C; 14 June. The main theme of this 2nd PDA Europe Annual Meeting is Global Healthcare of the Present & the Future, building a bridge between current demands in the global healthcare industry, big data issues as well as promising personalized medicine and medicinal products. The meeting will also include presentations from regulatory, industry and technology representatives from around the world. Get a comprehensive insight into manufacturing of parenterals, learn about new developments, current demands and get involved in discussions with experts. A continually changing regulatory environment poses a variety of challenges the pharmaceutical industry needs to tackle. Inspection trends will be reviewed from different angles, the regulator and industry perspectives.

Looking into the future, the meeting will highlight the understanding of modern engineering and how it can change the pharmaceutical world. Furthermore, the meeting addresses topics like the impact of Industry 4.0 on pharmaceutical manufacturing processes: in particular Human Factors, Connectivity and Handling and Management of Big Data. We look forward to seeing you in Berlin.

AREAS AND TOPICS OF INTEREST Manufacturing | Quality | Research & Development | Process Development | Start-up Technologies | Health Application Development | Technology/Information | Systems | Regulatory Affairs | Engineering | Laboratory Science | Information Technology | Validation | Training | Marketing/Sales | Consulting

VENUE

Hilton Berlin MohrenstraĂ&#x;e 30 10117 Berlin, Germany +49-30-20230 0 www.hilton-berlin. hotel-in-berlin.org/en/

Education Program Available For registration and further information: pda.org/eu-AnnualMeeting2017

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PDA Europe Conference, Exhibition

Advanced Therapy Medicinal Products Present and Future Developments in ATMPs

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27-28 June 2017 Valencia | Spain

WELCOME TO VALENCIA This yearâ&#x20AC;&#x2122;s Conference on Advanced Therapy Medicinal Products (ATMPs) will be held in Valencia, Spain from 27-28 June 2017.

ATMPs provide exciting and promising new concepts for therapy. This conference will cover a broad variety of essential biological information. The aim and scope of this meeting are to present and future developments in Gene and Cell Therapies, as well as the manufacturing and clinical implementation of ATMPs. This meeting has established itself among a distinct circle of international experts, regularly attended by leading representatives coming from government agencies (EMA/ CAT, EU Commission, etc.), academia and industry. Over the course of these two days, attendees will gain insights into current approaches by European regulators, and several of the leading industry and academic experts will share their unique perspectives and experiences. We look forward to welcoming you to beautiful Valencia!

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Hotel SH Valencia Palace Paseo Alameda, 32 46023 Valencia, Spain Tel: +34 96 337 50 37 hotel-valencia-palace.com/en/

AREAS AND TOPICS OF INTEREST Development | Manufacturing | QA | QC | Business Development | Regulatory Affairs of biopharmaceuticals | Gene & Cell Therapy | Academics | Engineering | Laboratory Science | Information Technology |

VENUE

Education Program Available

For registration and further information: pda.org/eu-ATMPs2017

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PDA Europe Conference, Exhibition

Pharmaceutical Freeze Drying Technology How to Answer the Growing Demand and Increase Flexibility in Lyophilization

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Copy right courtesy of GEA Group

19-20 September 2017 Cologne | Germany

WELCOME TO COLOGNE The aim of PDA Europeâ&#x20AC;&#x2122;s Freeze-Drying Conference is to foster an intensified and science-based discussion between experts from all areas of lyophilization: development, production, regulatory affairs and health authorities. Get in touch with these highly qualified and diverse professionals at 11th PDA Europe Pharmaceutical Freeze Drying Technology Conference in Cologne, Germany, 19 â&#x20AC;&#x201C; 20 September!

During the last ten years, freeze-drying of biopharmaceuticals has become a routine procedure, yet the freeze-drying process remains complex. This meeting provides updates of various technical and regulatory aspects regarding lyophilization.

Speakers from the pharmaceutical industry, manufacturers and regulatory agencies share their knowledge and give insights into this process, deepening the understanding of its underlying physicochemical principles as well as explaining freeze-drying techniques and the efforts to implement them on a big scale. As an attendee of this conference, you get to know current and novel concepts of freeze-drying, and you get to connect and exchange ideas with experts and fellow attendees. The friendly yet professional atmosphere of this meeting provides abundant opportunities for networking. So come and join us in Cologne!

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AREAS AND TOPICS OF INTEREST VENUE API Development & Production | Pharmaceutical Development and Production | Process Engineering | Process Development | QC & QA | Container Development | Quality Control Production/ Manufacturing | Information | Technology/ Information Systems | Project/Facility Engineering | Manufacturing Process/ Packaging | Marketing/Sales | Consulting

Lindner Hotel City Plaza Magnusstrasse 20 50672 Cologne Tel: +49 221 2034-700 lindner.de/en/colognehotel-city-plaza

Education Program Available For registration and further information: pda.org/EU-FreezeDrying2017

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PDA Europe Conference, Exhibition

PDA Europe Exchange Series 09 / 17 Meet, Exchange and Connect

Particles in Injectables

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Taking place concurrently to the 10th Monoclonal Antibodies Workshop

BUY ONE TICKET, ACCESS BOTH EVENTS!

26-27 September 2017 Berlin | Germany

WELCOME TO BERLIN 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. Please turn next page for a detailed overview of this workshop. Both events and its respective Education Program will join forces as part of the PDA Europe Exchange Series 09/17. This new conference format gives you the chance to "Meet, Exchange and Connect" with colleagues, peers and professionals from different backgrounds around the globe and participate in both conferences with just one meeting ticket.

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.

VENUE AREAS AND TOPICS OF INTEREST Sofitel Berlin KurfĂźrstendamm Augsburger Strasse 41 10789 Berlin, Germany Tel: +49 30 800 999 0 Fax: +49 30 800 999 99 H9387@SOFITEL.COM

Pharmaceutical/Biopharmaceutical Clinicians | Scientists | Doctors | Pharmacists | Quality | Research & Development | Process Development | Regulatory Affairs | Laboratory | Science |

Education Program Available For registration and further information: pda.org/eu/exchange-09

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PDA Europe Exchange Series 09 / 17 Meet, Exchange and Connect

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10th Workshop on Monoclonal Antibodies Taking place concurrently to Particles in Injectables conference

BUY ONE TICKET, ACCESS BOTH EVENTS!

26-27 September 2017 Sofitel Berlin KurfĂźrstendamm Berlin | Germany

WELCOME TO BERLIN This year, PDA celebrates the 10th anniversary of the Workshop on Monoclonal Antibodies, taking place in Berlin, Germany, 26 – 27 September, highlighting the achievements of this successful format over the past ten years. The Workshop will be part of the PDA Europe Exchange Series 09/17. The Series gives you the chance to “Meet, Exchange and Connect” with colleagues, peers and professionals from different backgrounds around the globe and participate in both series events - see Particles in Injectables conference in the previous page - with just one meeting ticket.

The 10th PDA Europe Monoclonal Antibodies Workshop will once again feature presentations about the latest developments, brought to you by international industry and regulatory experts, including a broad update on regulatory considerations. Aside from presentations, there will be various case studies and panel discussions regarding upstream and downstream process development, control strategy design, antibody related products and technological innovations. Traditionally, PDA Europe's Monoclonal Antibodies Workshop is an event which allows its attendees to interact intensely with colleagues, regulators, industry leaders and experts. So come to Berlin and use this chance to get involved!

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VENUE

AREAS AND TOPICS OF INTEREST

Sofitel Berlin Kurfürstendamm Augsburger Strasse 41 10789 Berlin, Germany Tel: +49 30 800 999 0 H9387@SOFITEL.COM

R&D | Development | Manufacturing | QA/QC | Business Development | Regulatory Affairs

Education Program Available For registration and further information: pda.org/eu-Monoclonals2017

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PDA Europe Conference, Exhibition

Pharmaceutical Cold & Supply Chain Logistics GxP Compliance to Secure Temperature-Controlled Supply

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10 â&#x20AC;&#x201C; 11 October 2017 Prague | Czech Republic

WELCOME TO PRAGUE Save the date for the 12th edition of the Pharmaceutical Cold & Supply Chain Logistics Conference which will take place 10â&#x20AC;&#x201C;11 October 2017 in Prague, Czech Republic.

Here, you will meet experts from every stage in the supply chain who will share their knowledge on topics such as air and ocean freight, crossing borders, transport risk mitigation, temperature monitoring, and last mile distribution.

After a medicine is manufactured, it may have to travel thousands of miles/kilometers before reaching its destination, be it a hospital, a pharmacy or a doctor. To ensure product quality and efficacy, the appropriate temperature needs to be monitored and ensured throughout every step of the journey.

The PDA Europe Pharmaceutical Cold & Supply Chain Logistics Conference has proven to be the ideal event to learn everything about the various risks and hazards involved along this path, and how to manage them according to GMP and GDP regulation. As an attendee, you can expect knowledge acquisition through presentations by excellent speakers as well as lively discussions for you to contribute to, and of course there will be plenty of opportunities for personal networking and exchange of ideas.

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NH Prague City Mozartova 261/1 15000 Prague nhpraguecity@ nh-hotels.com

AREAS AND TOPICS OF INTEREST API Development & Production | Pharmaceutical Development and Production | Process Engineering | Process Development | QC & QA | Container Development | Packaging | Manufacturing | Transportation and Logistics | Airlines | Cold Storage | Wholesale/Retail Pharmacy | Suppliers of Cold Chain Solutions | Cold Supply Chain | Logistic Service Providers/Carriers | Warehouse | Quality Release | Quality Assurance

VENUE

Education Program Available

For registration and further information: pda.org/eu-ColdChain2017

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PDA Europe Conference, Exhibition

The Universe of Pre-filled Syringes & Injection Devices The Must-Attend Event for the Pharmaceutical and Biopharmaceutical Industry

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7-8 November 2017 Vienna | Austria

WELCOME TO VIENNA During the last decade, PDA’s Universe of Pre-filled Syringes and Injection Devices has become the must-attend meeting for everyone working in the field, and is now the world’s largest conference on this subject. We are looking forward to welcoming you to the 14th edition of this event, to be held 7-8 November 2017 at the Austria Center in Vienna, Austria.

There is a continued process in the pharmaceutical and biopharmaceutical industry to improve the application of injectables. Starting from primary packaging solutions to devices with increased functionalities, new concepts are being developed to better serve patient needs. Innovations cover a broad range like new materials, new devices, smart devices, special application systems for challenging formulations. Together with these innovations, new manufacturing, handling and testing requirements need to be developed. Furthermore, regulatory demands are constantly changing too, posing challenges to everyone involved in pharmaceutical science, technology and manufacturing of parenterals.

PDA's The Universe of Pre-filled Syringes and Injection Devices brings together industry and regulatory experts annually to share their experiences, new developments, regulatory considerations, trends and best practices. Do not miss the opportunity to gain access to and network with key decision makers from the pharmaceutical industry as well as suppliers and manufacturers.

The Austria Center in Vienna has proven to be the ideal location for the European Edition of PDA’s The Universe of Pre-filled Syringes and Injection Devices, offering seemingly endless space and possibilities to create a very unique atmosphere, thereby contributing to the event's tremendous success in 2015. Austria's largest conference centre is located in the heart of the United Nations’ City Department of Vienna, only a few minutes from the center of one of Europe’s most vibrant cities.

Join us there, the perfect place to explore and get immersed in the pre-filled syringes universe!

AREAS AND TOPICS OF INTEREST Manufacturing | Quality | Research & Development | Process Development | Health Application Development | Regulatory Affairs | Engineering | Laboratory Science | Validation | Training | Quality Control Production/Manufacturing | Information | Technology/Information Systems | Project/Facility Engineering | Marketing/Sales | Consulting | Business Development

VENUE

Education Program Available

Austria Center Vienna Bruno-Kreisky-Platz 1 A-1220 Vienna acv.at

For registration and further information: pda.org/eu-UPS2017

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Outsourcing & Contract Manufacturing Establishing Effective Pharmaceutical Development and Manufacturing Partnerships

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21 â&#x20AC;&#x201C; 22 November 2017 Munich | Germany

WELCOME TO MUNICH The PDA Europe Outsourcing & Contract Manufacturing conference has been taking place since 2015 and has become a not-to-be-missed event for any professional interested in the field. This year’s event will take place from 21 – 22 November in Munich, Germany.

By featuring different industry approaches, the program focuses on the question of how to successfully collaborate on outsourcing of pharmaceutical products or services. Presentations are based on different case studies, which will provide insights into the elements needed for establishing an effective pharmaceutical development and manufacturing partnership. New types of collaborations and solutions will be presented, and engaging talks by internationally recognized experts will make this an exceptional event.

Join us this fall in Munich!

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AREAS AND TOPICS OF INTEREST VENUE

Roomers Landsberger Strasse 6880339 München Tel.: +49 89 2080393305 info@roomersmunich.com

Outsourcing | Strategic Sourcing | Global Supply | Purchasing | Technology Office | Pharmaceutical Development and Manufacturing | Analytical Functions | Business Development | Clinical Supply

Education Program Available

For registration and further information: pda.org/eu-Outsourcing2017

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Training & Education Program PDA

Education offers courses that are developed and taught by experts. They are uniquely targeted to professionals involved in the development and manufacture of quality pharmaceutical and biopharmaceutical products.

Facts that Make a Difference Up-to-date training courses and workshops taught by internationally renowned instructors Wide range of training courses with direct hands-on experience to drive expertise, awareness, and innovation Customized in-house training courses and workshops available

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2017 EDUCATION PROGRAM OVERVIEW

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16–17 February

Rapid Microbiological Methods

16–17 February

Practical Guide for Root Cause Investigations Methodology & Tool Kit

TC Porto, Portugal

13 March

Secondary Packaging for Parenterals

TC

13 March

Elastomers

TC

16 March

Container Closure Development

TC

16–17 March

Container Closure Integrity: Regulations, Test Methods, Application

TC

16-17 March

Extractables & Leachables

TC

16–17 March

Track and Trace: How to Implement Pharma Serialization, Tamper Evidence and the EU-Falsified Medicines Directive

TC

20 March

Particle Identification in Parenterals

TC

22–23 March

An Introduction to Visual Inspection: a Hands-on Course

TC

3–7 April

Praxis der Pharmazeutischen Gefriertrocknung – Course in German TC Osterode, Germany

3–4 May

Basics of Successful Auditing

TC Berlin, Germany

29 May

The Principles of Viral Safety of Biologics and Vaccines

WS

2 June

Virus Filtration

TC

12 June

Cleaning & Disinfection

TC

12 June

Supply Chain Strategies for API and Drug Product

TC

12 June

Quality by Design for Biopharmaceuticals

TC Berlin, Germany

15–16 June

Introduction to Aseptic Processing Principles

TC

15–16 June

Quality Culture

TC

26 June

Practical Applications of Phase-Appropriate GMP & Quality to Clinical Development of ATMP

TC

21 September

Application of a Risk-Based Approach to Freeze-Drying Processes TC

21–22 September

Development of a Freeze-Drying Process

TC

25 September

Particle Identification in Parenterals

TC

28-29 September

An Introduction to Visual Inspection: a Hands-on Course

TC

28 September

From Gene to Product – Tailormade Strategies for High Level Expression of Biologicals

TC

28 September

Testmethoden für vorbefüllte Spritzen – Course in German

TC

28–29 September

Best Compliance Practices im GMP Prüflabor– Course in German

28–29 September

CMC Regulatory Compliance for Biopharmaceuticals

TC Berlin, Germany TC

28–29 September

Extractables and Leachables

TC

28–29 September

DoE Basics for Validation by Design

TC

Subject to change

TC

Barcelona, Spain

Berlin, Germany

Dubrovnik, Croatia

Valencia, Spain

Cologne, Germany

Berlin, Germany

Shortlist 22 Mar 2017

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