The Parenteral Drug Association presents: st PDA Europe Annual … · 2016-05-27 · The Parenteral...

1st PDA Europe Annual Meeting

The Parenteral Drug Association presents:

T H E F U T U R E I N I N J E C T A B L E S

2016

30 June - 1 July Root Cause Investigation

30 June - 1 July Development of Pre-Filled Syringes

30 June Test Methods for Pre-Filled Syringes

30 June Cleaning and Disinfection

30 June How to Find the Right GMP for APIs

europe.pda.org/AnnualMeeting2016

28-29 June 2016 Estrel Hotel Berlin

Berlin | Germany

Gold SponsorPlatinum Sponsor Silver Sponsor Media Partner

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LETTER FROM THE CHAIR

Dear Friends, Colleagues, Collaborators and Peers,We are all witnessing a paradigm shift in scientific, technical and regulatory approaches to healthcare. Innovative technologies raise the quality and safety of our manufacturing and distribution processes and offer increased efficiencies and flexibilities. Regulatory oversight is becoming increasingly risk based and strives for convergence on a global scale. Our industry is evolving towards an increasingly agile and flexible manufacturing mode that can accommodate shifting demands, deliver innovative therapies, and master current and future healthcare challenges. 21st century manufacturing will be light years away from the traditional approaches we were accustomed to.

On 28-29 June 2016, PDA Europe’s first Annual Meeting The Future in Injectables will provide you with a first-hand opportunity to stay current and apprehend future advances in modern sterile manufacturing and quality oversight. We will offer you a very unique program with new and exciting topics, specifically aimed at reflecting innovative approaches and cutting edge technologies.

Renowned industry leaders and regulators will share their experience with you in daily plenary sessions and a series of parallel tracks. The opening plenary session will focus on strategies developed by partakers in healthcare to strive in the context of globalization and rapid scientific innovation. Concurrent sessions are designed to address many of the current challenges our industry and regulators faces. They will feature over thirty presentations with practical examples and case studies, and offer the perfect blend of industry updates, educational topics, technical advances and trends in regulatory oversight. We will dive deeply into continuous manufacturing, flexible facilities, modern analytical technologies, automation and robotics, blow-fill-seal technology, big data processing and ‘industry 4.0’, serialization and product tracking implementation, data integrity, innovative injection devices, and – last but not least – the related regulatory aspects. The conference will conclude with an outlook to the future of our industry, covering facilities, manufacturing and therapies of the future in a global context.

Opportunities to interact with speakers, industry peers, regulators, exhibitors and PDA leadership will be plenty. They include extended networking breaks, interactive roundtable discussions with PDA chapters from Europe and Japan and a very special European networking reception on the evening of June 28th.

As an extended offer, on June 30th and July 1st PDA Europe will be hosting several in-depth training courses that are designed to complement topics presented at the conference.

PDA Europe’s first Annual Meeting The Future of Injectables shows once again PDA’s commitment to bringing manufacturing technology advances to the forefront and facilitating discussions between industry, suppliers and regulators. You will leave the conference richer, both in terms of knowledge and relationships, which will benefit your career and organization.

Mark your calendars now and plan to join us in Berlin/Germany from June 28th to July 1st, 2016.

On behalf of the program planning committee and PDA staff, I look forward to welcoming you there!

Ursula Busse, PhD MBA, Novartis Group Quality Conference Chairwoman

http://europe.pda.org/AnnualMeeting2016

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1 Ursula Busse, Conference Chair, Novartis

2 Jette Christensen, Novo Nordisk

3 Véronique Davoust, Pfizer

4 Derek Duncan, LIGHTHOUSE

5 Gabriele Gori, GSK

6 Eric Meier, Novartis

7 Thomas Pospiech, Optima Pharma

8 Stephan Rönninger, Amgen

9 Mihaela Simianu, Amgen

10 Ryan Smith, Sight Machine

11 Jochen Strube, Clausthal University of Technology

12 Georg Roessling, PDA Europe

S C H E D U L E A T A G L A N C E

28 June 29 June

9:00 – 19:00 7:30 – 17:30

1st PDA Europe Annual Meeting Conference, Exhibition

30 June 9:00 – 17:00 Test Methods for Pre-filled Syringe Systems

One-Day-Training Course

30 June 9:00 – 18:00 Cleaning and Disinfection One-Day-Training Course

30 June 9:00 – 17:30 How to Find the Right GMP for APIs One-Day-Training Course

30 June 01 July

9:00 – 18:00 9:00 – 16:30

Root Cause Investigation Two-Day-Training Course

30 June 01 July

9:00 – 17:45 9:00 – 16:30

Development and Manufacturing of Pre-filled Syringes

Two-Day-Workshop

For latest information, please visit: europe.pda.org/AnnualMeeting2016

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P R O G R A M P L A N N I N G C O M M I T T E E

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P R O G R A M P L A N N I N G C O M M I T T E E

1 Ursula Busse, Conference Chair, Novartis

2 Stephan Rönninger, Amgen

3 Jette Christensen, Novo Nordisk

4 Derek Duncan, Lighthouse

5 Gabriele Gori, GSK

6 Eric Meier, Novartis

7 Thomas Pospiech, Optima Pharma

8 Mihaela Simianu, Amgen

9 Ryan Smith, Sight Machine

10 Jochen Strube, Clausthal University of Technology

11 Georg Roessling, PDA Europe

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CONFERENCE AGENDA

Tuesday, 28 June

9:00 Welcome: Opening Remarks, Introduction & PDA Awards Georg Roessling, PDA Europe Ursula Busse, Novartis, Conference Chair

Opening Plenary Moderator: Ursula Busse, Novartis

9:15 The Quality Journey: From Good to Great Martin van Trieste, Amgen

9:45 A Question of Trust – Hard Won, Easily Lost John Johnson, NSF Health Sciences

10:15 Overcoming the Divide of Excellence & Quality Thomas Friedli, University of St. Gallen

10:45 Coffee Break, Poster Session & Exhibition,European Chapter Activity

11:15 Regulatory Considerations for Continuous Manufacturing: EU Perspective

Jean-Louis Robert, European Medicines Agency, Chair of the CHMP/CVMP Quality Working Party

11:45 The International Role of PIC and PIC/S in Harmonizing Inspections Paul Hargreaves, MHRA, PIC/S

12:15 Q&A, Discussion

12:45 Lunch Break, Poster Session & Exhibition,European Chapter Activity

13:40 Transition to Parallel Tracks

P A R A L L E L T R A C K S

Rooms A B C

TRACK A TRACK B TRACK CSession 1 Continuous Manufacturing

& Flexible Facilities TestingLifecycle Management

and Innovation:Are they Mutually Exclusive?

27 May 2016



CONFERENCE AGENDA

Moderators: Mihaela Simianu, Amgen Jette Christensen, Novo Nordisk Ursula Busse, Novartis

Session 1 Continuous Manufacturing& Flexible Facilities Testing

Lifecycle Management and Innovation:

Are they Mutually Exclusive?

13:45 Concepts and Solutions for Continuous Manufacturing

Eric Meier, Novartis

Attribute Focus to Achieve the Quality Target Product Profile (QTPP)

Rohini Deshpande, Amgen

Challenges of Pharma Industry with Lifecycle Approach

Anders Vinther, Sanofi Pasteur

14:15 Process Development and Engineering Challenges for Future Manufacturing of Biologics

Jochen Strube, Clausthal University

Post Approval Lifecycle Manage-ment of Analytical Control Systems

Emma Ramnarine, Genentech / Roche

From QbD to Lifecycle Management: Regulatory Perspective of Guide-lines that should Encourage Innovation - Opportunities and Challenges

Jean-Louis Robert, European Medicines Agency, Chair of the CHMP/CVMP Quality Working Party

14:45 Traceability in Continuous Manufacturing

Jochen Thies, Glatt Group

All-in-One Solution for Parenteral Containers CCI Testing and Headspace Gas Verification

Andrea Simonetti, Bonfiglioli Engineering

Recent Initiatives put Forward by the WHO to Facilitate Post-Approval Change Management for Vaccines

DianLiang Lei, WHO

15:15 Q&A, Discussion Q&A, Discussion Q&A, Discussion



Rooms A B C

TRACK A TRACK B TRACK CSession 2 Automation & Robotics Testing Blow-Fill-Seal

Moderators: Masahiro Akimoto, OtsukaStephan Rönninger, Amgen

Jette Christensen, Novo Nordisk Georg Roessling, PDA Europe

16:15 Nanoparticle Technology in Phar-maceutical Applications

Sanshiro Nagare, Nara Machinery

Testing of Final Product during Scale Up: Lessons Learned

Derek Duncan, LIGHTHOUSE

Speaker to be confirmed



CONFERENCE AGENDA

Session 2 Automation & Robotics Testing Blow-Fill-Seal

Moderators: Masahiro Akimoto, OtsukaStephan Rönninger, Amgen

Jette Christensen, Novo Nordisk Georg Roessling, PDA Europe

16:45 A New Generation Packaging Line for Filled Product in Carton with Integrated Dividers

Hiroaki Mizuno, Omori Machinery

CCIT Technology on BFS Containers: From the High Speed Testing Prospective, the Testing Reliability and the Validation Approach

Jaime Combo, Wilco

Basic Principles and Regulatory Requirements for BFS Technology including Qualifications and Validation Aspects

Christoph Bohn, Holopack Packaging Technology

17:15 Overview of the Low Voltage Electron Beam Sterilization System and its Benefits

Koji Kawasaki, AirEX

In-Line Automated Visual Particle Inspection of BFS Containers for Injectable Drug Products

Heino Prinz, rommelag

Specific Aspects for Manufacturing and Autoclaving of BFS Products

Martin Haerer, Holopack Packaging Technology

17:45 Moderator:Masahiro Akimoto, Otsuka

Roundtable DiscussionBusiness Opportunities Japan

Session Speakers

Moderator:Gabriele Gori, GSK Vaccines

Roundtable Discussion Final Product Control:CCIT & Visual Inspection– Do we need it? What will Annex 1 bring?

Session Speakers

Experience with Filling of Biological Products with Cool BFS Technology

Otto Schubert, Maropack

18:30 End of Day 1

19:00 Joint Departure & Networking Event @ Pier13


Summer in BerlinNetworking Event


Meeting Point: Hotel Estrel - PDA Registration Desk

Shuttle Bus leaving at 19:00hShuttle Bus returning to the Estrel Hotel 22:30hDress Code: Casual Summer Look

Please confirm your attendance at the PDA Registration Desk. If you have any dietary requirements, please let us know.

Pier 13 | Tempelhofer Damm 227 | Tempelhofer Hafen | 12099 Berlin

SPECIAL ACT:

HEAR THE FIRST PDA BAND PLAYING.


CONFERENCE AGENDA

Wednesday, 29 June

7:30 Welcome Coffee

M O R N I N G R O U N D T A B L E S

8:00 MEET THE PDA CHAPTERS

PDA has 24 Chapters around the world with local programs and resources to help you stay informed, interact with your peers, and facilitate exchange with the pharmaceutical and biopharmaceutical industry. Meet six of these chapters in this morning session and get to know the chapter presidents and industry peers in your region!

ITALY / SWITZERLAND (TESSIN)

FRANCE UK IRELAND ISRAEL JAPAN

I N T E R E S T G R O U P M E E T I N G T E C H T R A N S F E R ( T T I G )

8:00 • Scope and Activities• Technical Report #65• TT IG current picture

- Membership, Geographic distribution, Expertise onboard

• Goals for 2016 & Next steps• Q&A, Discussion

IG Leader:Mirko Gabriele, Patheon


Rooms A B C

TRACK A TRACK B TRACK CSession 3 Big Data Processing / Industry 4.0 Regulatory Track Technical Track

Moderators: Georg Roessling, PDA Europe Gabriele Gori, GSK Vaccines Mihaela Simianu, Amgen

9:10 Industry 4.0 - Readiness for Pharmaceutical Companies

Andreas Traube, IPA Fraunhofer Institute

What an Inspector Needs to Know About Assessment

Kevin O’Donnell, Health Products Regulatory Authority, Ireland (HPRA)

Serialization Requirements in Europe

Véronique Davoust, Pfizer

9:40 Technology Road Map Industry 4.0

Francisco Herrador, Altran

Challenges in Pharmaceutical Industry-SME Perspective

Andreas Sachse, CPL SACHSE

Serialization and Product Tracking Implementation in a Global Environment

Michael Ritter, Novartis

27 May 2016



CONFERENCE AGENDA

Session 3 Big Data Processing / Industry 4.0 Regulatory Track Technical Track

10:10 Manufacturing & Big Data: Approaches for Pharma

Toni Manzano & Pep Gubau, BigFinite

Import of Pharmaceutical Products: Annex 21, OECD Guideline

Stephan Rönninger, Amgen

Track and Trace Implementation in Iran

Akbar Abdollahi, IFDA



11:25 Transition to Parallel Tracks


Rooms A B C

TRACK A TRACK B TRACK CSession 4 Modern Analytical Techniques Data Integrity Drug Administration

Moderators: Derek Duncan, LIGHTHOUSE Stephan Rönninger, Amgen Eric Meier, Novartis

11:30 Predictive Modelling and Real-time Analytics Applied to Fill and Finish Operations

Cenk Undey, Amgen

DI – A Criminal Act? Overview, Clarification, Definition

Anil Sawant, Merck & Co.

Innovative Drug Delivery

Ian Thompson, Ypsomed Delivery Systems

12:00 Digital Transformation for Biotech-nology: A Big Data Approach to Manufacturing Analytics

Ryan Smith, SightMachine

Data Integrity for Computer Systems – A Bumpy Road to Compliance

Wolfgang Schumacher, Roche

Smart Medication–Where Electronics meet Drug Delivery

Markus Bauss, SHL Connect

12:30 Automated Media Fill Inspection

David Brueckner, Roche

Data Integrity – A Holistic Approach

Madlene Dole, Novartis

Best Practice in Glass Handling During Ddevice Development and Commercialization

Thomas Schoenknecht, SHL Medical


13:15 Lunch Break, Poster Session & Exhibition,European Chapter Activity



CONFERENCE AGENDA

Session 5 : Closing Plenary - Future Developments Moderator: Ursula Busse, Novartis

14:15 Past & Future of Injectable Dosage Forms for Biologics – Quo vadis, Parenteralia?

Hanns-Christian Mahler, LONZA

14:45 Necessities and Possibilities of New Manufacturing and Facility Design Maik Jornitz, G-Con Manufacturing

15:15 Requirements and Opportunities for the “Parenteral Facility of the Future”

Morten Munk, NNE Pharmaplan


16:15 Challenges for Medical Treatment in Future Samvel Azatyan, WHO

16:45 Panel Discussion: The Future of Injectables

Participants:• Hanns-Christian Mahler, Lonza

• Samvel Azatyan, WHO

• Paul Hargreaves, MHRA and Chair of PIC/S

• Steven Lynn, Novartis (and former FDA)

17:30 Closing Remarks, End of Conference & Farewell Coffee

15-16 November 2016 Olivia Balmes HotelBarcelona | Spain

Register by 15 Oct 2016 and SAVE!

2016 PDA Europe

Outsourcing & Contract Manufacturing


14 NovemberRisk-based Approach for Prevention and Management of Drug Shortages

15-16 NovemberConference, Exhibition

17 November Quality by Design for Biopharmaceuticals

17-18 NovemberRoot Cause Investigation



During all coffee and lunch breaks, you have the opportunity to visit the Poster Session located in the Exhibition Area. Poster presenters will be happy to welcome you and answer your questions.

Shlomo Sackstein, Biopuremax

Biopuremax- Pretreatment Water System

Kavita Ramalingam lyer, Merck Sharp & Dohme Corp.

Annex 2 and a Case Study Enabling Risk-Based Biopharmaceutical Facility Design Approaches

Paul Lopolito, STERIS Corporation

A Scientific Approach to Maintain your Stainless Steel Surfaces

POSTER SESSION

This Poster Session is still open for your proposal. Please submit directly to Sylvia Becker at [email protected]

Elizabeth Rivera, STERIS Corporation

Cleaning Validation Concerns for Continuous Manufacturing

Christa Jansen-Otten, West Pharmaceutical Services

Component Selection Strategies for PFS: Risk Mitigation, Performance and Larger Injection Volume Driving Innovative Solutions


mailto:becker%40pda.org?subject=

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ESTREL HOTEL & CONGRESS CENTERBERLIN



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Table Top (3 x 2 m)

C: Chapter / Table Top (2 x 2 m)

Diamond Sponsor (4 x 2 m)

Platinum Sponsor (3 x 2 m / 4 x 2 m)

Gold Sponsor (3 x 2 m)

Silver Sponsor (3 x 2 m)

Buffet/Coffee Station

FLOOR PLANESTREL HOTEL BERLIN

cGMP Processing of Sterile Products Afton Scientific



CONFERENCE AGENDA

www.terumo-gps.com

Global Pharmaceutical Solutions

Sensitive biopharmaceuticals? We take the challenge

• Drug delivery solutions & technologies for injection and infusion

• Expert platforms in pharmaceuticals, polymers, coatings, precision and miniaturization technologies

• Uncompromised Quality and Regulatory Affairs support

• Committed to improved drug delivery and patient comfort

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The Parenteral Drug Association presents...

PDA Education Program

30 June 2016Test Methods for Pre-filled Syringe Systems One-Day Training Course

30 June 2016Cleaning and Disinfection One-Day Training Course

30 June 2016How to Find the Right GMP for APIs One-Day Training Course

30 June - 01 July 2016Root Cause Investigation Two-Day Training Course

30 June - 01 July 2016Development and Manufacturing of Pre-filled Syringes Two-Day Workshop



ONE-DAY TRAINING COURSE

Who Should Attend:

This course will be beneficial to individuals work-ing in Product Development, Quality Management, Regulatory Affairs and Manufacturing of syringe systems and related delivery devices

Learning Objectives:

Upon completion of this course, you will be able

• To understand the pros and cons of the different materials used for the Pre-filled Syringe

• To apply existing standards and monographs for specific syringe testing

• To explain the testing rationales used for test meth-ods at different stages

• To create a own testing plan according to your spe-cific application

Horst Koller, CEO, HK Packaging Consulting GmbH

Prior to becoming a consultant, Horst worked for Abbott Diagnostic and SCHOTT Pharmaceutical Packaging with a total of more than 20 years industry experience. His consulting company is focussing on Technical, Regulatory and QM-Support around Primary and Sec-ondary Packaging Systems including Medical Devices. He is an active member within the technical ISO Committees TC76 and TC84 as well as an active speaker on international conferences. He holds an Engineering degree in Biotechnology from the University of Applied Sciences in Mannheim / Germany.

OverviewPre-filled Syringes (PFS) are used for different applications and throughout many therapeutic areas. They are available in glass and polymer, with and without needles already pre-attached to the syringes. Pre-filled Syringes fulfill two tasks: storage container and delivery device in one and the same system.The more components are used in such systems the more complex it will get, additionally if such Pre-filled Syringes are used in Auto-injectors or other delivery devices.

This one-day course will cover a short introduction into common materials used for the development and manufacturing of syringe systems. The main focus is on the test methods which are relevant for the different stag-es of a Pre-filled Syringes.

Test Methods for Pre-filled Systems



TRAINING COURSE AGENDA

27 May 2016

Thursday, 30 June 2016 9:00 – 17:00

9:00 Welcome

9:15 Introduction to Syringe Systems & Components• Polymer Syringes• Glass Syringes• Rubber Components and Closures

10:15 Luer Cone and Luer Lock Compliance Testing for Glass and Polymer Syringes

11:00 Coffee Break

11:30 Requirements for the Empty Sterile Sub-assembled Syringe Ready for Filling• Cone Breakage• Flange Breakage• Leakage

12:30 Lunch Break

13:30 Requirements for the Empty Sterile Sub-assembled Syringe Ready for Filling (continued)• Break-loose and Gliding Forces• Needle Penetration• Particulate Matter• Endotoxins

14:30 Requirements for Finished Pre-filled Syringes • Pharmacopeia• FDA

15:30 Coffee Break

16:00 Additional Testing for Use in Delivery Devices• Auto-Injectors

17:00 End of Training Course




Peter Koger, Technical Sales Manager International, Veltek Associates Inc.

Peter Koger MSc. has been active in life science for over 35 years. First 12 years were spend in different laboratories in microbiology and the remainder working for various international organizations, active in the life science/pharmaceutical industry. For about 20 years Peter has been a technical resource to the pharmaceutical industry in relation to viable monitoring, cleaning & disinfection, and other aspects related to Aseptic Manufacture and Contamination Control. Since 2002, he is a frequent industry speaker and since 2004, Peter has been a faculty member of PDA and other training institutes. Peter worked with several companies to help them get to best practice

level in Cleaning & Disinfection. Since 2005, Peter is working with Veltek Associates Inc., a leading manufacturer of sterile disinfectants, detergents, viable monitoring equipment and several other innovative products focused on Contamination Control in the Pharmaceutical and Biotech industry. In his role, Peter is Technical Sales Manager responsible for Europe and part of Asia.

Cleaning and DisinfectionA practical approach

Who Should Attend:

• Production management• Operators responsible for/involved in C&D• Quality/Microbiology management• Quality personnel involved in C&D


At the end of the workshop attendees should be able to develop or evaluate an existing cleaning and disinfection program in line with regulatory expectations and facility’s requirements for contamination control of classified areas.

Overview

This interactive course deals with all aspects of cleaning and disinfecting a sterile manufacturing facility. The information shared will encompass Regulatory aspects, Environmental Monitoring, Contamination sources, Selection of disinfectants and cleaning agents, the Validation and how they should be used properly.

Thursday, 30 June 2016 9:00 – 18:00

9:00 Welcome & Introduction

Subject Introduction | General Framework | Directives / Guidelines / Expectations

10:30 Coffee Break

Environmental Monitoring and Risk Analysis | Root Cause of Contamination

12:30 Lunch Break

13:30 Selection criteria | Validation | Means and Methods

15:30 Coffee Break

Practical Approach | Supplies and Tools | Case Studies




Advanced aseptic packaging in one operation cycleReliable – Simple – Cost-Effective

bottelpack® Technology:• Integrated clean room US-class 100• Recognized by GMP, FDA, JP …• Aseptic packaging of liquids, creams, ointments …• Endless container designs in PE, PP…

Your benefits:• Tamper-proof packaging• Easy to open• Simple to use• Shatter-proof, no splinter hazard

www.rommelag.com

rommelag agP.O. Box · CH-5033 Buchs, SwitzerlandPhone: +41 62 834 55 55 Fax: +41 62 8345500E-mail: [email protected]

rommelag Kunststoff-MaschinenVertriebsgesellschaft mbHP.O. Box 1611 · D-71306 Waiblingen, GermanyPhone: +49 7151 95811-0 Fax: +49 7151 15526E-mail: [email protected]

rommelag USA, Inc.27905 Meadow Drive, Suite 9Evergreen CO 80439, USATel: +1.303. 674.8333 Fax: +1.303.670.2666E-Mail: [email protected]

rommelag Trading (Shanghai) Co., Ltd. Room 104~107,1st Floor, No.510 Zhongshan South 2nd Road,Xuhui District, Shanghai, 200032 P.R. ChinaPhone: +86 21 5153 4967, +86 21 5153 4968 Fax No.: +86 21 5153 4969E-mail: [email protected]

ADV_3in1_EN_164x235mm_2015.indd 1 05.10.15 16:45



An ICH Q7 expert working group member instructs


Who Should Attend:

This course is designed specifically for those in-volved or interested in the manufacturing of APIs, the suppliers to API manufacturers or CMOs of APIs. The targeted audience comes from:

• Quality• Production• Logistics • Engineering


Upon completion of this course, the attendee will be able to:

• Avoid an over-interpretation of the GMP requirements in API manufacturing

• Know the keywords of the ICH Q7 guideline and how to interpret the guideline correctly

• Know the different responsibilities of quality and production

• Realize the additional GMP requirements for Bio-technology APIs

• Understand the meaning of ‘critical’ and its impact on quality processes

• Determine at which point in API manufacturing GMP needs to be applied

• Know how materials are re-used in a correct manner• Know what needs to be documented and which

departments are involved

Lothar Hartmann, Ph.D., Managing Director, IQP Consulting

Lothar Hartmann served at Hoffmann-La Roche in numerous functions nationally and globally. Lothar acted as Global Head of “Pharma-ceutical Quality Systems & External Relations”, interacting with regulatory health authorities and associations, and as “Global Head of Knowledge Management”. He also acted as Head of Quality at Crucell Berne, a Johnson & Johnson Group of Companies, before he built up his own company ‘IPQ Consulting’. Lothar Hartmann served for more than 10 years on the board of APIC/CEFIC as Vice-Chairman. In this function, he was nominated for the ICH Q7a Expert Working Group, writing the worldwide-harmonized GMPs for APIs. In this effort,

he also was FDA awarded in May 2004. He also founded and chaired the internationally recognized EBEs BioManufacturing Working Group for a number of years. Lothar is co- and lead-author of various documents published by CEFIC/APIC and EBE (European Biopharmaceutical Enterprises). He also served on the “Board of Directors” of PDA, chaired the European Interest Group on Quality Systems and was co-founder of PDA’s “Paradigm Change in Manufacture” (PCMO) project which had the objective to address practical solutions for the day-to-day business of the new paradigm of ICH Q8 – Q11. Lothar Hartmann graduated from the Technical University of Berlin.

OverviewWhen API manufactures received their own GMP guideline by ICH, an important step was reached since there are significant differences between GMP requirements for Drug (Medicinal) Products and those for APIs.

This course will provide practical guidance of key aspects laid down in the ICH Q7 guideline. It will clarify and lay out the appropriate GMP standard to be applied by API manufacturers. In particular, it will address GMP related topics of quality, production, logistics, engineering and biotechnology.

PDA Europe is proud to offer participants this unique opportunity to receive first-hand knowledge, interpretation and understanding of ICH Q7, and to ask questions to one of the ICH Q7 authors.

How to Find the Right GMP for APIs:




27 May 2016

Thursday, 30 June 2016 9:00 – 17:30

9:00 Welcome & Expectation Round of Participants

9:30 Regulatory Environment for APIs

10:00 Quality

10:30 Coffee Break

11:00 Workshop (Draw Flowchart for Handling Deviations/Investigations)

11:30 Discussion of Outcome of Workshops

12:00 Keywords of ICH Q7

12:30 Lunch Break

13:30 Documentation

14:00 Workshop (Key Items of Major SOPs)

14:30 Discussion of Outcome of Workshops

15:00 Coffee Break

15:30 General GMPs for Production, Logistic & Engineering

16:00 Re-use of Materials

16:30 Special Requirements for Biotechnology

17:00 Final Discussion Round




TWO-DAY TRAINING COURSE

Who Should Attend:

Alumni of this program typically (though not exclu-sively) have a background in:

• Quality• Risk management• Regulatory affairs• Compliance• Manufacturing• Product development• CAPA• Supply chain & purchasing• Production• Engineering• Project management• R&D• Fraud management• and more


Upon completion of the workshop, participants will able to immediately, effectively, and efficiently apply the methodology to:

• Identify the technical root cause(s), that is, the change(s) that occurred.

• Identify systemic root cause(s), that is, any underlin-ing breakdown in the organizations broader systems that allowed the change(s) to occur.

• Implement a comprehensive corrective and/or pre-ventive action plan to restore performance.

• Implement a control plan to minimize and/or pre-vent recurrence.

Rob Weaver, President of Weaver Consulting

Founded in 2003, Weaver Consulting is a two-person enterprise comprised of Tom Weaver and Rob Weaver. They are quality and oper-ations improvement consultants who focus their business exclusively on root cause analysis. With a combined 40+ years’ experience and a client base that expands worldwide, they have helped organizations across a multitude of highly regulated industries, including pharmaceutical, medical device, aerospace, defense, financial services, food & beverage, consumer products, automotive, telecom-munications, semiconductors, and many more, successfully implement their premier root cause analysis methodology, Root Cause

Investigation for CAPA. Both Tom and Rob held titles of Vice President in their respective careers before joining the firm, Tom with Baxter Healthcare and Rob with Wells Fargo & Company.

OverviewRoot Cause Investigation for CAPA is an informative, practical, and engaging two-day workshop teaching a system-atic, science based, and proven methodology ideal for investigating any performance change. Examples: change in the performance of a product (tangible or intangible), machine or equipment, work process or system (physical or virtual), escalated customer complaints, etc. Based upon 40+ years’ experience, the methodology integrates problem solving techniques from Total Quality Management (TQM), Six Sigma, Kaizen, DMAIC (define, measure, analyze, improve, control), as well as other problem solving and process improvement techniques.

On day one, the participants are introduced to the seven step root cause investigation methodology. An Investi-gation Roadmap is provided to guide the participants through the steps and suggest appropriate tools. After each step is presented leveraging an instructor case study, the participants immediately apply the learning on their own case study (which is based upon a real life investigation). On day two, several hours are devoted to strength-ening the participants’ skills leveraging the methodology through practice on another, more complex, real life case study. As the participants work on this case study they will compare their work with that of the investigation conducted by the real team.

Participants will be emailed a set of electronic templates. These templates, plus the investigation roadmap, guide the investigator through the methodology and provide the basis for documentation.

Root Cause Investigation for CAPA




Thursday, 30 June 2016 9:00 – 18:00

9:00 Welcome & Introduction• Define technical CAPA problem• Common investigation mistakes• Investigation Roadmap template• Introduce 1st participant real life case study

10:00 Step 1: Define the Performance Problem• Introduce instructor case study• Problem statement• Problem description

10:30 Coffee Break

11:00 Step 1 Continued• Problem description continued• Workshop• Flow chart process(es) being investigated & identify key

inputs• Workshop• Time of events• Team charter including performance & cost savings goals

12:00 Lunch Break

13:00 Step 2: Collect Data• Determine data needed• Data collection tools & techniques• Data measurement plan• Workshop

15:00 Coffee Break

15:30 Step 3: Identify Possible Causes• Time of changes• Differences between Is & Is Not facts• Workshop• Changes associated with identified differences• Review risk analysis• Brainstorming techniques• Workshop

16:30 Step 4: Test Possible Causes• Test possible causes against facts• Summarize testing leveraging contradiction matrix• Historical perspective of investigations• Workshop

17:30 Step 5: Identify Technical & Systemic Root Causes• Verify assumptions• Conduct studies/experiments• Identify technical root cause(s)

18:00 End of Day 1

27 May 2016

Friday, 1 July 2016 9:00 – 16:30

9:00 Step 5 Continued• dentify systemic root causes

9:30 Step 6: Determine Corrective/Preventive Actions• Mistake proofing techniques• Variation reduction & optimization techniques• Corrective/preventive actions• Acceptance criteria

10:30 Coffee Break

11:00 Step 6 Continued• Risk mitigation• Control plan• Workshop

11:45 Step 7: Verify Corrective/Preventive Actions• Implement & measure corrective/preventive actions• Evaluate control plan• Determine additional preventive actions

12:00 Lunch Break

13:00 Second Participant Real Life Case Study• Introduction• Workshop to develop problem statement, problem

description, identify possible causes• Workshop to collect data• Workshop to test possible causes

15:00 Coffee Break

15:30 Second Participant Real Life Case Study Continued• Workshop to determine corrective/preventive actions

including risk mitigation, control plan, acceptance criteria

13:00 Closing Remarks• Compare/contrast this investigation methodology

with traditional approach• Shortcuts• Simple investigations• Difficult investigations• Investigation report• Return on investment• references

16:30 End of Course



Including hands-on exercises with equipment for processing, inspection and control

TWO-DAY WORKSHOP

Who Should Attend:

This course offers valuable insights and updates for anyone involved in development, production, quality, and purchasing of pre-filled syringes and relevant equipment


You will learn how:

• Processes involved in primary packaging manufac-turing, filling and processing influence quality

• Relevant equipment can be used to achieve reproducible quality


Overview

This two-day workshop will provide an overview of relevant practical aspects and trends of developing and processing pre-sterilized primary packaging systems. It will also focus on hot topics such as aseptic environments, particulates, silicone and single-use filling. In addition to theoretical insights, participants will have the opportunity to use equipment and perform testing by themselves in hands-on sessions. Processing steps, inspection and quality aspects will be demonstrated using state-of-the-art technology.

Moderator: Christa Jansen-Otten, Director Marketing PFS Europa, West Pharmaceutical Systems Horst Koller, CEO, HK-Packaging Consulting

Speaker: Simone Biel, Field Marketing Specialist SU, Merck Millipore Josef Veile, Technical Director, Groninger Patrizia Wenzel, Sales Manager, Biesterfeld Spezialchemie

Faculty



WORKSHOP AGENDA

27 May 2016

Thursday, 30 June 2016 9:00 – 17:45

9:00 Welcome and Introduction Christa Jansen-Otten, West

9:15 Market Overview and Trends in Primary Packaging:• Global & Regional Pharmaceutical Market / Injectable Market /

Challenges / Changes in Manufacturing / Devices

Christa Jansen-Otten, West

9:45 The Complete Process to Manufacture Pre-filled SyringesFrom Washing to Packaging, Part I:• Machine and Equipment / Bulk and Ready to Use Concepts /

IPC / RABS and Isolators

Josef Veile, Groninger

10:45 Coffee Break

11:15 The Complete Process to Manufacture Pre-filled SyringesFrom Washing to Packaging, Part II:• Machine and Equipment / Bulk and Ready to Use Concepts /

IPC / RABS and Isolators

Josef Veile, Groninger

11:45 Silicone: “The Chemistry Behind It” / Chemical and Physical Aspects Patrizia Wenzel, Biesterfeld Spezialchemie

12:15 Lunch Break

13:15 Single-Use in Final Filling:• Process Design • Quality Considerations

Simone Biel, Merck Mllipore

14:00 A Comparision of Pre-filled Syringes Filling Operations in RABS and Isolators

M+P speaker

14:45 Coffee Break

15:15 Hands-On Training using Industry Equipment:• Silicone distribution (rap.ID)• Siliconization (Groninger)• Silicone chemical/physical aspects (Biesterfeld)• Single Use (Merck Millipore)• Filling (Groninger)

hands-on exercises

17:15 Q & A

17:45 End of Day 1



Friday, 1 July 2016 9:00 – 16:30

9:00 Material, Manufacturing, Process and Quality Effects on Glass:• Polymers / Coating / Multilayer

Horst Koller, HK Packaging

9:45 Elastomeric Closures for Pre-filled Syringe and Cartridge Applications: • Manufacturing / Requirements / Coatings / Quality / Extractable /

Regulatory / Adopted Packaging

Christa Jansen-Otten, West

10:45 Coffee Break

11:15 Comparing Different Solutions on Nested Containers• BD / Gerresheimer / NIPRO / OMPI / Schott / West


11:45 Q&A on Nested Packaging Horst Koller, HK Packaging

12:00 Development and Regulatory Aspects of Primary Packaging Material: • Transfer from Vial into Syringe


13:00 Lunch Break

14:00 Hands-On:• Stoppering (Groninger)• Particle Identification (rap.ID)• Primary Packaging (West)• Packaging and Components (HK Packaging)

Practical Training provided by various suppliers

16:00 Open Discussion

16:30 End of Workshop

WORKSHOP AGENDA



20-21 September 2016 Radisson Blue es. Hotel

Rome | Italy

Register by 20 August 2016

and SAVE!


2016 PDA Europe 9th Workshop on Monoclonal Antibodies

pda.org/EU/MAB2016

Ensuring mAbs’ Quality – Current Considerations for Control Strategy Design

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

22 September Elastomers

22-23 September CMC Regulatory Compliance for Biopharmaceuticals

22-23 September Extractables and Leachables

22-23 September Introduction to Aseptic Processing Principles

22-23 September Statistics of Production Monitoring and Capability



INFORMATION

V E N U EEstrel BerlinSonnenallee 22512057 BerlinGermanyTel.: + 49 (0) 30 683 10Mail: [email protected]://www.estrel.com/en/hotel.html

Housing at the selected hotel will be in high demand, so we strongly recommend making your reservations early.

CO NTAC T I N FO R M ATI O NConference InquiriesMelanie DeckerDirector Events & [email protected]

Conference Program InquiriesSylvia BeckerManager Programs & [email protected]

Registration & Customer CareTel: + 49 30 [email protected]

Education Program InquiriesElke von LaufenbergManager Training & [email protected]

Exhibition/Sponsorship Inquiries Creixell Espilla-GilartManager Exhibition & Sponsorship [email protected]

G E N E R A L A D D R E S SPDA Europe gGmbHAm Borsigturm 6013507 Berlin, GermanyTel: + 49 30 4365508-0Fax: + 49 30 [email protected]

CO N F E R E N C E R EG I S TR ATI O N H O U R SMonday, 27 June: 9:00 – 18:00Tuesday, 28 June: 8:00 – 18:00Wednesday, 29 June: 7:00 – 17:00

CO U R S E R EG I S TR ATI O N H O U R SThursday, 30 June: 8:00 – 16:30Friday, 01 July: 8:30 – 12:00

TO E X H I B ITExhibition and Sponsorship Opportunities are available. PDA meetings and conferences are a great opportunity for your company to gain on-site exposure in front of high-ly-qualified, upper-level professionals in the pharmaceuti-cal and biopharmaceutical industry. Exhibit at PDA events and let your company’s products or services become a valuable tool or resource for our attendees. Please see the Exhibition Floor Planorg go to: europe.pda.org/AnnualMeeting2016

S PEC I A L R EQU I R E M E NT SIf you require special accommodations to fully par- ticipate, please attach a written description of your

needs with your registration form. Specific questions can be directed to [email protected].

Special offer: Discounted travel with Lufthansa Group Airlines

Lufthansa Group Par tner Airlines of fer a comprehensive global route network linking major cities around the world. We offer spe-cial prices and conditions to par ticipants, visitors, exhibitors, in-vited guests as well as employees of the Contracting par tner and their travel companions. To make a reser vation, please click on www.lufthansa.com/event-booking_en and enter the access code DEZZYGX in the "Access to Your Special Lufthansa Offer" area. This will open an online booking platform that will automatically calcu-late the discount offered or provide you with an even better offer if another promotional fare is available.

NOTE: Pop-ups must be enabled otherwise the booking platform window will not open.

These promotional fares are also available through your IATA / ARC travel agent. Travel agents can obtain ticketing instructions by send-ing an email to [email protected] and providing the access code as a reference.

https://goo.gl/maps/Q99HdV8HPf12

D I R EC TI O N S

© Google For directions click

on the picture, scan the QR-code or go to


https://goo.gl/maps/Q99HdV8HPf12


Helpful Hints When Registering for PDA Europe Events

M A K I N G I T E A S I E R F O R B OT H O F U S

Registration cannot be completed by sending Purchase Order alone. A Purchase Order is only accepted if a complete registration form is enclosed or follows very soon.

4 Purchase Orders

1 Please include your member ID number on registration form if available/known

If uncertain about your member ID number and/or your membership status, call or email us.+49 (0)30 43 655 08-10 [email protected]

2 Do not send money in advance

Please wait until we send our invoice to you. It is helpful to reference our invoice number in your bank transfer details.

6 Please state the correct billing address on the registration form

This is particularly important if billing address and site address are different. Contact your accounting depart-ment for correct address and company name. There could be special requirements for accounting. Changes in the billing address (if induced by participating company) will be charged 25,- € if imposed 3 weeks prior to the start of the event.

9 Substitutions

If a participant is unable to attend, substitutions are welcome at any time. Changes are free of charge until 3 weeks prior to the start of the event. After this date, there will be a charge of € 50 per name change.

7 Confirmation of your registration

Credit card charges are confirmed immediately if successfully approved.Bank transfers are confirmed upon receipt of full payment.

8 Refund/Credit Notes

Refunds to credit card can be done immediately if payment had been done by credit card and details are available. Refunds to bank accounts can be done if payment had been done by bank transfer and the following details are provided: a) Name of your bank b) IBAN number c) Swift/BIC code

3 Complete and sign the event registration form

Please note the registration and cancellation policies at the bottom of the form.

5 Please state VAT ID number if European-based Company

This number starts by your country code(example: PDA Europe’s VAT ID number = DE254459362)

THANK YOU FOR YOUR COOPERATION!



Registration Form − Page 1

PDA Europe Conference, Exhibition, Workshops, Training Courses

1st PDA Europe Annual Meeting28 June - 01 July | Berlin | Germany

Your registration is only complete upon filling in and submitting both pages of this form.

1 RegistrationNo PDA membership included

Please mark here if your company is an exhibitor to this event and you will receive the conference ticket at the special price of 1295 Euro per ticket. No further discounts are applicable with this option (as PDA Membership Discount or Group Ticket discount).

*Discount for Exhibiting Companies

30 June One-Day Training Course Training Course Fee netto

Test Methods for Pre-filled Syringe Systems All Participants 695


How to Find the Right GMP for APIs All Participants 695


Cleaning and Disinfection All Participants 695

30 June - 01 July Two-Day Training Course Training Course Fee netto

Root Cause Investigation All Participants 1395

30 June - 01 July Two-Day Workshop Workshop Fee netto


All Participants 1495

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 course 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 25 March 2016 and save! EARLY BIRD DISCOUNT

28-29 June Conference only Conference Fee By 25 March 2016 After 25 March 2016

1st PDA Europe Annual Meeting PDA Member 995 1595Nonmember 1645 1895

Regulatory / Academic 700 800Discount for Exhibiting Companies (see below)*

This PDF-file provides an automatic fill-in function. Your signature, however, is needed in writing.


http://www.pda.org/Membership


Date Mandatory Signature

Your registration is only complete upon filling in and submitting both pages of this form.

3 Payment Options

Billing Address: Same as contact information address above. If not, please send your billing address to: [email protected]

By Bank Transfer Beneficiary: PDA Europe gGmbHIBAN: DE73 1007 0024 0922 8735 00 BIC (SWIFT-Code): DEUTDEDBBERBank Address: Deutsche Bank, Welfenallee 3-7, D-13465 Berlin, Germany

By Credit Card (one week prior to event)

American Express MasterCard VISA

For your credit card information safety:Please send your details by fax only.

Purchase Order

Purchase Order Number

Job Title *

Mailing Address

Substituting for(Ch e ck only i f you are subs t i tut ing for a pre v iously e nrolle d colleag ue; a nonme mb e r subs t i tut ing for me mb e r mus t pay t h e me mb e r ship fe e.)

* This information will be published in the conference attendee list. Should you not wish us to publish these details, please contact us.

1 Your Contact Information

PDA MemberName (Last, First, MI) *

ID Number

Country Email *

FaxBusiness Phone

Company* Department

City Postal Code

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

• 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 sub-mitting 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).

2 Information about Visa Matters

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. You must have a written confirmation (including invoice) to be considered enrolled in a PDA event. Please allow one week for receipt of confirmation letter. Payment must be received or guaranteed by Purchase Order or credit card details on 1st day of event, at the very latest. 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 per name change. REFUNDS: Refund requests must be sent to PDA Europe. If your written request is received on or before 28 May 2016, 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 4365508-66. DOCUMENTATION: With your signature you give complete picture usage right to PDA and allow to film your exhibition space and intervention in the event, including the recording of your presentation for video purposes (with your slides, voice and image). This right extends also to the use of the resulting images in film documentation for webinars and similar items produced by PDA.

PDA Europe VAT I.D.: DE254459362Your 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)

Registration Form − Page 2

PDA Europe Conference, Exhibition, Workshops, Training Courses

1st PDA Europe Annual Meeting28 June - 01 July | Berlin | Germany

4 WAYS TO REGISTER

ONLINE: europe.pda.org/AnnualMeeting2016FAX: +49 30 4365508-66EMAIL: [email protected] MAIL: PDA Europe, Am Borsigturm 60, 13507 Berlin, Germany

1234

This PDF-file provides an automatic fill-in function. Your signature, however, is needed in writing.


www.europe.pda.org

General InformationPDA Europe gGmbHAm Borsigturm 60 13507 Berlin, GermanyTel: +49 30 4365508-0Fax: +49 30 4365508-66

Conference InformationMelanie DeckerDirector Events & ExhibitionsTel: + 49 30 [email protected]

Training Course InformationElke von LaufenbergManager Training & EducationTel: + 49 30 [email protected]

LegendIG – Interest Group MeetingTC – Training CourseWS – Workshop

2 0 1 6 P D A E U R O P E A C T I V I T I E S & E V E N T S 31 May - 1 June

Current Challenges in Aseptic Processing, Potential Changes in EMA/PIC/S Annex 1 Revision

WS Berlin, Germany

6 June7-8 June9 June9 June

Viral Safety of ATMPs | Conference Advanced Therapy Medicinal Products | ConferencePractical Application of GMP for Development of ATMPsVirus Filtration

TCTC

Berlin, Germany

28-29 June30 June30 June30 June30 June - 1 July30 June - 1 July

1st PDA Europe Annual MeetingTest Methods for Pre-filled Syringe SystemsCleaning and Disinfection How to Find the Right GMP for APIsRoot Cause Investigation Development and Manufacturing of Pre-filled Syringes

TCTCTCTCWS

Berlin, Germany

20-21 September22 September22 September22-23 September22-23 September22-23 September22-23 September

9th Workshop on Monoclonal AntibodiesElastomersRecombinant Proteins: From Gene to Product CMC Regulatory Compliance for BiopharmaceuticalsExtractables and LeachablesIntroduction to Aseptic Processing PrinciplesStatistics of Production Monitoring and Capability

TCTCTCTCTC

Rome, Italy

27-28 September29 September29-30 September

Pharmaceutical Freeze Drying Technology | ConferenceApplication of a Risk-Based Approach to Freeze-Drying ProcessesDevelopment of a Freeze Drying Process

TCWS

Strasbourg, France

5-6 OctoberCurrent Challenges in Aseptic Processing, Potential Changes in EMA/PIC/S Annex 1 Revision

WS Dublin, Ireland

10 October11-12 October13-14 October

Interest Group Meeting Pharmaceutical Cold ChainPharmaceutical Cold & Supply Chain LogisticsGood Cold Chain Practices

IG

WS

Amsterdam, The Netherlands

24 October25-26 October27-28 October

Particle Identification in Parenterals Visual Inspection ForumAn Introduction to Visual Inspection: A Hands-on Course

TC

TCBerlin, Germany

8-9 November Data Integrity WS Berlin, Germany

14 November15-16 November17 November17-18 November

Risk-based Approach for Prevention and Management of Drug ShortagesOutsourcing & Contract Manufacturing | ConferenceQuality by Design for BiopharmaceuticalsRoot Cause Investigation

TC

TCTC

Barcelona, Spain

Subject to change For latest info: europe.pda.org Shortlist 27 May 2016

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