2018 PDA Europe Events Booklet by Parenteral Drug Association

2018 PDA Europe Events Continue Your Journey

TABLE OF CONTENTS

Page

Content

Date

Welcome to PDA Europe

The Success of PDA Europe

PDA Conference Formats – New Ways of Interaction

Parenteral Packaging – Welcome to Rome

27 – 28 February

Vaccines – Welcome to Málaga

24 – 25 April

Virus Forum – Welcome to Florence

8-9 May

Annex1 – Welcome to Dublin

17 May

Pharmacopoeia Conference – Welcome to Vienna

29-30 May

Advanced Therapy Medicinal Products – Welcome to Amsterdam

5-6 June

3rd PDA Europe Annual Meeting – Welcome to Berlin

26-27 June

Pharmaceutical Microbiology – Welcome to Berlin

15 – 16 October

Visual Inspection Forum – Welcome to Berlin

23 – 24 October

Outsourcing & Supply Chain - A 360° View – Welcome to Seville

6-7 November

Project Management in the Pharmaceutical Industry – Welcome to Berlin

22 November

Workshop on Monoclonal Antibodies – Welcome to Seville

27-28 November

Pharmaceutical Freeze Drying Technology – Welcome to Seville

27-28 November

PDA Education Program

PDA Membership

Why Exhibit at a PDA Event For latest info: pda.org/pda-europe

twitter.com/pdaonline

Subject to change

twitter.com/PDA_Europe

LinkedIn.com/company/PDA

... with our 2018 Events in Europe “Education is the most powerful weapon you can use to change the world”. This wisdom by Nelson Mandela well describes the essence of the work PDA has been doing throughout the past 70 years since its inception in 1946. A milestone in this development was the establishment of PDA Europe in 2006. The Parenteral Drug Association, as a non-for-profit organization, creates awareness and understanding of important issues facing the pharmaceutical and biopharmaceutical industries, and delivers education for these communities. Following PDA’s mission of Connecting People, Science and Regulation, PDA Europe has developed 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 efficiently and most effectively. The PDA Europe Exchange Meeting Format (p. 30-33) combines different 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, is one of the core objectives of PDA Europe.

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

Kerstin Wilken, PhD Director Programs & Education wilken@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

Teresa Schubach Manager, Programs & Events schubach@pda.org

PDA is a global organization and so are our conferences. This year’s Pharmaceutical Microbiology (p. 22) conference will take place simultaneously in in Europe and the United States. We will simulcast selected sessions in an effort of providing our attendees a truly global experience. The 2018 Education Program presents various training courses with revised content together with completely new ones - a highlight is the cooperation with local universities like Clausthal-Zellerfeld, where PDA Europe supports courses focused in biopharmaceutical manufacturing. In 2017, we were able to welcome more than 3,200 participants from 47 countries to our conferences, workshops and training courses. All events in 2018 will once more provide you with a variety of opportunities for exchange and networking with representatives of international authorities and organizations, industry experts, suppliers as well as universities and research institutions. Join us in 2018 to experience events focused on presenting new perspectives on innovative technologies, updates on regulatory changes guidances and to give you practice-oriented expert advice.

Creixell Espilla-Gilart Manager Marketing espilla@pda.org

Nadjeschda Gomez-Stahl Manager, Exhibition & Sponsorship gomez@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

The team at PDA Europe is looking forward to welcoming you to our events in 2018!

Falk Klar, PDA Europe

THE SUCCESS OF PDA EUROPE

CONFERENCE ‘16

1590%

‘06

ATTENDEES

205

‘06

800%

279

‘16

COMPANIES

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.

EXHIBITION

55%

FERE N CO

6 4%

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.

2.17

3.257

U R D A L NCE

PAR

Established in 2006, it coordinates the association´s activities from its office in Berlin, Germany.

IT I

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ON *

B O R ERS H OLD ET HAN 10 >7 6C ount ries ar

47 COUNTRIES Regulators

UG AS

E 1946

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

Academics

I AT

Industry

ENCE *

CONTINUE THE

PDA EUROPE

HISTORY

E D A

E S L R R O I N E E AS B

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TRAINING

I A R

PR OLE

NG *

M PE ME

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‘16 ‘06

2000%

501

STUDENTS

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.

Data as per year 2016 * The data provided represents a conservative estimate

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

INDUSTRY

SUPPLIER

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.

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

27-28 February 2018 Marriott Rome Park Hotel

Rome | Italy

Marriott Rome Park Hotel via Colonnello Tommaso Masala 54 Rom 00148 Italy +39-06-658821

The Parenteral Drug Association presents:

Parenteral Packaging Container CIosure Best Practices Throughout the Product Life Cycle

PDA Europeâ&#x20AC;&#x2122;s Conference has become a must-attend event for all professionals in the Parenteral Packaging arena. Join us in Rome, Italy on 27-28 February 2018 to continue and further deepen scientific advancements and our ongoing professional discourse of latest on primary packaging technologies and business trends. This conference and the accompanying exhibition address quality of components and contÂainers, container closure development and integrity testing as well as aspects of processing, product distribution and storage.

For registration and further information: www.pda.org/EU/parpack2018

24-25 April 2018 Melia COSTA DEL SOL

Málaga | Spain

Hotel Melia COSTA DEL SOL Paseo Marítimo, 11 29620 Torremolinos Malaga, Spain +34 952 386677

Vaccines The Parenteral Drug Association presents:

The PDA Europe Vaccines conference provides an overview of vaccine development & life cycle management, their impact and future. The conference will address new trends in vaccine development and life cycle management, including (1) use of platform technologies, (2) prior knowledge, (3) development of novel vaccines comprising therapeutic vaccines and cancer vaccines, and (4) considerations on accelerated development scenarios. In this context, Quality by Design principles have now been embedded in various aspects of vaccine development and beyond. The conference will provide an overview of the applicability of QbD in various aspects, from product, analytics and process standpoint and considerations during life cycle management, as well as touch base on newer trends in the regulatory field such as ICHQ12.

For registration and further information: pda.org/EU/Vaccines2018

15-16 May 2018 Hilton Florence Metropole

Florence | Italy

Hilton Florence Metropole Via del Cavallaccio 36 Florence, 50142 Italy +39-055-78711

The Parenteral Drug Association presents:

Virus Forum Advanced Technologies for Virus Detection & Clearance in Biological Products

The Virus Forum conference was established in 2001 and it has been taking place alternatively in the USA and Europe. The Forum is 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 safety of biotechnology, plasma-derived and cell-derived medicinal products. The Forum stands out for giving attendees a unique opportunity for interactive discussion and benchmarking. PDA fosters an exchange of information between industry and regulators, improving the understanding and acceptance of new techniques, highlight new and emerging risks and explain new regulatory approaches.

For registration and further information: pda.org/EU/Virus2018

17 May 2018 Crowne Plaza Dublin â&#x20AC;&#x201C; Blanchardstown

Dublin | Ireland

Crowne Plaza Dublin Blanchardstown Town Centre Dublin 15, Ireland +353 1 897 7777

Annex 1 The Parenteral Drug Association presents:

The long-awaited draft of the revised Annex 1 has finally been released for discussion! The documentâ&#x20AC;&#x2122;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.

For registration and further information: pda.org/EU/Annex2018

29-30 May 2018 Hotel Renaissance Vienna

Vienna | Austria

Hotel Renaissance Vienna Ungargasse 60 1030 Vienna, Austria 43 1-71175 0

The Parenteral Drug Association presents:

Pharmacopoeia Conference

Convergence, Harmonization & The Future Direction of Pharmacopoeias

PDA Europe is happy to announce the inaugural edition of the Pharmacopoeia Conference in 2018. A pharmaceutical product submitted and marketed in different countries or economic regions must comply with the respective pharmacopoeias legally binding in those countries and regions. Typically, however, international pharmacopoeias differ in the quality requirements for the same product. Compliance, therefore, becomes a major challenge for pharmaceutical companies, resulting in the need to develop and maintain labor-intensive and costly processes. PDA has invited several representatives from the most relevant pharmacopoeias to share approaches to international convergence, harmonization & the future direction of pharmacopoeias with respect to the overall framework of regulations and guidelines. On the other hand, the Pharmaceutical Industry will provide insights into their best-practices to effectively and efficiently implement international pharmacopoeial requirements. Join us in Vienna for the first edition of this conference!

For registration and further information: pda.org/EU/pharma2018

5-6 June 2018 Novotel Amsterdam Schiphol Airport

Amsterdam | The Netherlands

Novotel Amsterdam Schipol Airport Taurusavenue 12 2132 LS Hoofddorp +31 20 721 9180

The Parenteral Drug Association presents:

Advanced Therapy Medicinal Products

After many years of pioneering activities in cell and gene therapy with some ups and many downs, the field accelerated all of a sudden with a number of major industry and investor activities. PDA Europeâ&#x20AC;&#x2122;s ATMPs conference has become a fixture in the calendar for all professionals working in the field of cell and gene therapy based drug products. The conference offers a professional discussion forum for current themes around Advanced Therapy Medicinal Product. PDA invites representatives from the industry, research organizations and regulatory authorities to discuss the many challenges involved in the development, testing, production and registration of ATMPs - the most innovative and important field for advancement of our community. Join the discussion and shape the future of healthcare with PDA and celebrate with us a special milestone in 2018: the 10th Anniversary of this conference!

For registration and further information: pda.org/EU/atmps2018

26-27 June 2018 Marriott Hotel

Berlin | Germany

Berlin Marriott Hotel Inge-Beisheim-Platz 1 10785 Berlin, Germany +49 30 220000

The Parenteral Drug Association presents:

3 PDA Europe Annual Meeting rd

Global Healthcare of the Present & the Future

Following the success of the PDA’s US Annual Meeting, taking place annually since 1951, PDA initiated the European Annual Meeting in 2016 to celebrate PDA Europe’s 10th Anniversary. The Annual Meeting brings together members and those-soon-to-be with the current scientific and regulatory topics in the pharmaceutical industry. PDA has grown quite a bit since 1951, counting more than 10.000 individual members worldwide in 2017. PDA members are spread around the world and so the association’s activities. With PDA Europe coordinating all the activities in this continent since 2006, there is a growing membership in this continent as a result. In the 10th anniversary of the foundation of the Europe office, PDA organized the first European Annual Meeting to respond the demand for a central meeting for all European members, following the model of the US event. The third edition of the EU Annual Meeting will continue last year’s motto on Global Healthcare of the Present and the Future. You can expect a program connecting topics such as current demands in the global healthcare industry, big data issues as well as promising personalized medicine and medicinal products. Check the website for further updates on the program.

For registration and further information: pda.org/EU/Annual2018

15-16 October 2018 Marriott Hotel

Berlin | Germany

Berlin Marriott Hotel Inge-Beisheim-Platz 1 10785 Berlin, Germany +49 30 220000

The Parenteral Drug Association presents:

Pharmaceutical Microbiology Simulcast Conference

15-16 October | Berlin | Germany 15-17 October | Bethesda | USA Pharmaceutical Microbiology is an essential part of any aseptic manufacturing process. Environmental monitoring, bioburden control and sterility testing are key elements that must be considered in terms of securing product quality. Microbiology is not only essentially important in terms of product sterility, it also plays a major role in manufacturing medical products. Crucial medicines are made of microbiological products, for example vaccines, antibiotics and hormones. Â Complex manufacturing processes, such as fermentation or cell culture are used in production. These products represent an on-going challenge that shapes the future of medicine. The PDA Pharmaceutical Microbiology conference will feature presentations and case studies, accompanied by poster presentations as well as an exhibition showcasing technologies and trends in this exciting and diverse field, fostering a professional exchange amongst its participants. In 2018, this conference will be a truly global event! Taking place simultaneously in two different regions of the world, it will bring together industry, academic and regulatory experts to discuss Microbiology and its vast spectrum of possibilities. The conference will be complemented by an extensive Education Program. Check our website for the most recent updates.

For registration and further information: pda.org/EU/PharmaMicro

23-24 October 2018 Marriott Hotel

Berlin | Germany

Berlin Marriott Hotel Inge-Beisheim-Platz 1 10785 Berlin, Germany +49 30 220000

The Parenteral Drug Association presents:

Visual Inspection Forum Visual inspection, and especially the detection of particles, remains at the center of many discussions regarding product manufacturing control, quality assurance and regulatory compliance and it continues to be an important element of the manufacturing process and the quality assurance of injectable products. Since 2000, PDA has organized the Visual Inspection Forum to discuss new technical and regulatory developments in this field. This meeting alternates between the United States and Europe. In its European turn in 2018, the forum will provide a platform to present and discuss new developments in the field of visual inspection, including a basic understanding of the sampling and inspection process, special aspects of biotech products, practical aspects of manual and automated methods and the regulatory and compendia requirements that govern them. The Forum will be completed with an extensive Education Program, check the website for further updates. See you in Berlin!

For registration and further information: pda.org/EU/VIF2018

6-7 November 2018 Hotel MeliĂ Sevilla

Seville | Spain

Hotel MeliĂ Sevilla Calle Dr. Pedro de Castro, 1, 41004 Seville, Spain

The Parenteral Drug Association presents:

Outsourcing & Supply Chain – A 360° View The procedure of manufacturing and distributing pharmaceutical products from production to patient access is a highly complex process involving many different players. To achieve their common goal of providing patients with high quality medicine in sufficient quantities, all these players need to converge successfully. PDA Europe has designed a new conference with the objective to cover the whole supply chain from raw materials to last-mile distribution. One main topic of this event will be the interaction and dependencies between all the functions involved, such as developers, suppliers, manufacturers, logistics and storage companies, as well as testing labs. Only a few big players can execute all these functions with their own resources – the reality has proved that smaller companies must outsource or partner with other companies to succeed. With this conference, PDA offers a new platform for all professionals involved in this field to explore and discuss new developments and opportunities. One of the highlights of the event will surely be the new interactive session, integrated within the conference’s main program, where all interested parties will have the opportunity to interact with potential partners to discuss possible projects. Join us and be a part of this exciting interplay.

For registration and further information: pda.org/EU/2018Outsourcing

22 November 2018 Hotel Marriott Courtyard

Berlin | Germany

Courtyard by Marriott Berlin Axel Springer Str. 55 10117 Berlin, Germany +49-30-800 928 0

The Parenteral Drug Association presents:

Project Management Challenges & Possibilities

Process development, tech transfer, installation of new manufacturing lines, building of facilities and many more projects in the pharmaceutical industry greatly benefit from the proficiency of skilled Project Managers. Although general standards for performance of PM, such as ISO 21500 are available, the pharmaceutical industry has not yet defined a tailored best practice to capture the unique challenges within this industry. This new and innovative PDA event will provide a forum to discuss current practise, the advantages industry standards can offer and the outlook on future trends.

For registration and further information: pda.org//EU/PM2018

27-28 November 2018 Hotel MeliĂ Sevilla

Seville | Spain

Hotel MeliĂ Sevilla Calle Dr. Pedro de Castro, 1, 41004 Seville, Spain

The Parenteral Drug Association presents:

Workshop on Monoclonal Antibodies

Three decades after the licensure of the first monoclonal antibody, interest remains strong in this product class. An estimated 300 compounds are currently in various stages of clinical development for treatment of cancers, inflammatory and autoimmune diseases and other disorders. The intense focus on monoclonal antibodies has in turn driven significant developments in the chemistry, manufacturing and control aspects associated with commercial production. The PDA Workshop offers an overview on all these developments, inviting speakers from both the manufacturing as well as regulatory side. The workshop takes place annually since 2007, and it stands out as one highly interactive event with presentations, case studies and panel discussions. In 2018, the workshop will be, together with the Freeze Drying Conference, part of the PDA Exchange Series Format. Take advantage of this innovative format to PDA meet, exchange and connect with other professionals in the biopharmaceutical industry! H ES····

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For registration and further information: pda.org/EU/MABS2018

27-28 November 2018 Hotel MeliĂ Sevilla

Seville | Spain

Hotel MeliĂ Sevilla Calle Dr. Pedro de Castro, 1, 41004 Seville, Spain

The Parenteral Drug Association presents:

Pharmaceutical Freeze Drying Technology

The Freeze Drying conference started in 2007 and since then, it has been fostering science- based discussion between experts in the particular area of lyophilization. In the past, some people believed that pharmaceutical freeze drying may just be a fashionable trend, soon replaced by liquid formulation that is fully stable over years. Looking at the current market, however, freeze dried products are well established and continue to grow in quantity. The PDA conference presents in its yearly update to the industry current examples of this evolutionary process, from the industrial equipment, process understanding and formulation design. The conference and its accompanying program offer you many ways to interact: Hear from experts in the conference sessions, see the advancements on technology at the exhibition and learn on freeze drying specific topics in the training courses. In 2018, the Freeze Drying conference will be with the Monoclonal Antibodies Workshop part of the PDA Exchange Series Format. Take advantage of this innoPDA vative format to meet, exchange and connect with other professionals in the biopharmaceutical industry! H ES····

··

···EXC

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E GE S

For registration and further information: pda.org/EU/FreezeDrying2018

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 handson experience to drive expertise,awareness, and innovation

Customized in-house training courses and workshops available

2 01 8 PDA EU RO PE E D U C ATI O N PRO G R A M 25–28 February Downstream Processing (DSP) Purification of Biomolecules 27 February 1 March

CBP - Continuous Bioprocessing of Biomolecules

1 March

Container Closure Development

1-2 March

Container Closure Integrity Testing

1-2 March

Extractables & Leachables

28-29 June

Practical Approach to Quality Culture

28-29 June

Best Compliance Practices at the GMP Testing Laboratory

28-29 June

Test-Methods for Pre-filled Syringes Systems

4-5 September

Mastering Environmental Monitoring

10 April

Particle Identification in Parenterals

12-13 September Best Practices for Glass Primary Containers

11-12 April

An Introduction to Visual Inspection: A hands-on course

17-18 October

Rapid Microbiological Methods

Mastering Automated Visual Inspection

17-18 October

Best Practices and Points to Consider in Aseptic Processing

Quality Culture Transformation Resources

22 October

Particle Identification in Parenterals

25-26 October

An Introduction to Visual Inspection: A hands-on course

23-27 April

Freeze Drying in Practice

25-26 October

Mastering Automated Visual Inspection

7 June

Practical Application of PhaseAppropriate GMP & Quality to Clinical Development of ATMPs

More information – europe.pda.org

11-12 April

17-18 April

20-21 June

Temperature Controlled Distribution: An Interactive Walk Through

Subject to change

Seven Reasons to Join 36

Member Benefits Summary

View over 60 Technical Reports in our online TR Portal for free!

Network with regulators and industry experts through events , the new online discussion forum PDA ConnectSM and volunteering.

Read the latest research on the PDA Journal of Pharmaceutical Science and Technology website.

Catch up on industry and Association news with the PDA Letter.

Grow your local network and learn about issues affecting your region through chapter involvement.

Gain access to professional resources like our Online Membership Directory and PDA Career Center.

Take advantage of discounts on conferences, courses and books.

Join PDA today and boost Your career! pda.org/membership

Why Exhibit at a PDA Europe Event

POSITION YOUR BR AND AT T H E B E S T VALUE

Branding your company within the field As a non-for-profit organization PDA offers affordable exhibition and sponsorship opportunities adapted to all budgets

Platform for introducing new products or services Best ratio in high quality attendees and low cost for branding

MEET YOUR CUSTOMER

Attendance of industry leader during an event High volunteer engagement of speakers and Committee Members during the whole event

BEST CONNECTION TO THE R EG U L AT I O N AUTHORITIES

Get direct and personal feedback from the regulatory authorities PDA has more than 200 members in the regulatory field

Quality of Personal Contacts Very high personal exchange amongst members and no members - high value & quality networking through Membership

Contact Follow-Up The PDA Community has several interest groups, with industry and vendors, that give the pulse of what is needed and foster a vivid exchange before, during and after the event

For more information please contact Nadjeschda Gomez-Stahl Manager, Exhibition & Sponsorship expo-europe@pda.org +49 30 4365508-23

We look forward to meeting you in 2019!

Connecting People, Science and RegulationÂŽ