Pre-filled Syringes Conference 2019,

Innovations & Developments : A Decade at a Glance

26-27 February 2019

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Applications for Speaker Positions for 2019 Open

 

Prefilled syringes (PFS) constitute one of the fastest growing segments of the injectable drug delivery device market.  The administration of therapeutic drugs via injection is an indespensable delivery method for numerous drugs critical to patient health and well-being. A prefilled syringe is defined as a single-dose packet of vaccine to which a needle has been fixed by the manufacturer.  Typically metal and glass have been common in the past, however there has been a shift towards plastic and disposable syringes, so the needle is protected and cannot be reused (prefilled disposable systems).

 Estimates show that the global prefilled syringes market , is likely to reach sales of  6.9 billion by 2018, growing at a compound annual growth rate of 13.8% from 2012 to 2018 . Many examples of drugs packed into prefilled syringes are vaccines, blood stimulants, therapeutic proteins, erythoprotein.

The pharmaceutical market promises high potential for prefilled syringes, however production costs are high and manufacturing is complex.  Industrial pressure arising concerning pharmacovigilance and reducing cost suggest there are still challenges to overcome.

Why you should attend this conference:

 

08:30 – Coffee and registration – An opportunity to meet and to network with your conference colleagues. 

09:30 – Chairperson opening remarks
Sabrina Daw, Commercial Director, Lexicorp
 

Innovations & Developments: A Decade at a Glance

 

DEVELOPMENT & ENHANCEMENT IN DESIGN & MANUFACTURING 

 

09:40 – EU regulation of pre-filled syringes

 

09:40 – Prefilled Syringes and Packaging 

TBC


10:20 – Digital Health for Drug Delivery

TBC

11:00 – Morning Coffee/Tea & Discussion

11:30 –  Risk mitigation strategies and documentation for extractable, leachable and interactions in PFS 

CARSTEN WORSOE, Principal Scientist, NovoNordisk

QUALITY & SAFETY OF PRE-FILLED SYRINGES

11:50 – Enhancing prefilled syringe compoenent quality

BRAM JONGEN, Head of R&D , Datwyler Sealing Solutions

12:30 – Networking luncheon

Safety Challenges related to prefilled syringes

13:40 – Panel Discussion - The safety challenges in relation to prefilled syringes

Moderator:


Panellists:
TBC
FRANZ KAINZ, Vice President, Sterile Contract Manufacturing Services, Fresenius Kabi
 

14:20 – Clearance and approval designs considerations

Andrew Fielden, Chemistry Operations Director,  Smithers Rapra Ltd


15:10 – Afternoon Tea/Coffee

15:30  Industrial termination sterilization of heat and radiation senitive products by low temperature VHP (Vaporized Hydrogen Peroxide) 

AMIT KHANNA, Application Project manager, Team Lead, STERIS

16:10 – The future of safety systems for pre-filled syringes, with case study


16:50 – Chairperson’s closing remarks and end of conference

17:00 – 18:00 – Networking Drinks Session

 

 

 

 

 

08:30 – Coffee and registration – An opportunity to meet and to network with your conference colleagues.

09:30 – Chairperson opening remarks
Sabrina Daw, Commercial Director, Lexicorp

REGULATORY CONSIDERATIONS  & COST EFFICIENCY

 

09:40 – EU regulation of pre-filled syringes

FABIEN ROY, Counsel Life Sciences , Hogan Lovells



10:20 – Formulation aspects in PFS development of biologics 

TBC

 

10:50 – Morning Coffee/Tea & Discussion


11:10 – International recommendations and regulations for successful drug approval

Moderator:
FRANZ KAINZ, Vice President, Sterile Contract Manufacturing Services, Fresenius Kabi

Panellists:

TBC

11:50 – Connected Medical Devices

TBC


12:30  Networking luncheon

CURRENT MARKET DYNAMICS PROSPECTS FOR THE FUTURE

13:30 – Benefits and hurdles of device development

Moderator:
Andrew Fielden, Chemistry Operations Director,  Smithers Rapra Ltd


Panellists:
STEVEN LYNUM, President and Member of the Board of Directors, Panasonic Healthcare Corporation


14:10 – A prefilled syringe commercialization strategy

STEVEN LYNUM, President and Member of the Board of Directors, Panasonic Healthcare Corporation

14:50 – Connected Health and regulated combination products

Neil Williams, Director Front End Innovation-head of Connected Health, Medicom innovation Partner Ltd

15:20 – Afternoon Tea/Coffee

15:40 – Consider design factors and material selection

MAX CAMBRAS, Strategic Advisor in Life Sciences, L.E.K Consulting


16:20 – Panel Discussion: Evaluate new technology and market development

Moderator:


Panellists:
TBC
STEVEN LYNUM, President and Member of the Board of Directors, Panasonic Healthcare Corporation

17:00  17:10 – Chairperson’s closing remarks and end of the conference

Key Speakers

Sabrina Daw, Commercial Director, Lexicorp  (Conference Chair)

Andrew Feilden, Chemistry Operations Director, Smithers Rapra Ltd

Max Cambras, Strategic Advisor in Life Sciences, L.E.X consulting

Carsten Worsoe, Principal Scientist, NovoNordisk

Franz Kainz, VP Contract Manufacturing for Sterile Pharmaceutical for Fresenius Kabi

 

 

Paul Upham, Senior Principal, Genentech

Neil Williams, Director Front- End Innovation- Head of Connected Health, Medicom Innovation Partner

Fabien Roy, Counsel Life Sciences, Hogan Lovells

Amit Khanna, Application Project Manager, Team Lead, Steris

 

Bram Jongen, Head of R&D, Datwyler Sealing Solutions

Steven Lynum, President & Member of the Board of Directors, Panasonic Healthcare Corporation (PHC)

 

 

1st degr
1st degree coSterile Contract Manufacturing Services at Fresenius Kabi

And Many More....................................................

 

 

 

 

Workshops: 27th Feb, 2019

08:30 – Coffee and registration – An opportunity to meet and to network with your conference colleagues. 

09:30 – Chairperson opening remarks
Sabrina Daw, Commercial Director, Lexicorp

Masterclass A: Prefilled Syringes & Parenteral Contract Manufacturing- Product Differentiation is critical. 

Date: 27th Feb, Time 09:45-16:00

Masterclass Leader: 

STEVEN LYNUM, President & Member of the Board of Directors ,  Panasonic Healthcare Corporation (PHC)

 

Masterclass B: The next generation of quality and safety of Prefilled Syringes

Date: 27th Feb, Time 09:45-16:00

Masterclass Leader: 

 

 

 

Masterclass C: Prefilled Syringes: it is not as simple as cost or regulatory considerations alone

Date: 27th Feb, Time 09:45-16:00

Masterclass Leader: 

 

 

About L.E.K. Consulting

L.E.K. Consulting is a global management consulting firm that uses deep industry expertise and rigorous analysis to help business leaders achieve practical results with real impact. We are uncompromising in our approach to helping clients consistently make better decisions, deliver improved business performance and create greater shareholder returns. The firm advises and supports global companies that are leaders in their industries — including the largest private and public sector organizations, private equity firms and emerging entrepreneurial businesses. Founded in 1983, L.E.K. employs more than 1,200 professionals across the Americas, Asia-Pacific and Europe. For more information, go to www.lek.com.

 

 

 

About Smithers

 Smithers offers a range of testing services for the medical and pharmaceutical industries, supporting you at every part of your path to market. Our services help clients demonstrate compliance to regulatory guidance or specifications set out by the FDA, EMA, MHRA, USP, ASTM and ISO:

* Pharmaceutical and Medical Device Chemical Analysis

*Drug Delivery Device and Accessories Testing

* Healthcare Product and Packaging Validation

*Support Demonstrating Regulatory Compliance

*Material Selection, Characterisation and Testing

Our experience team provides excellent guidance on polymer and packaging materials to support clients in meeting design specififcations. Working in compliance with international standards, we rountinely develop and validate product test methods and provide independent measurement and assessment of qualification and rountine batch conformation.

Smithers laboratories are UKAS ISO 17025 accreditied.  We work with clients to provide work to cGMP principles.  We are members of Internaional Safe Transit Association (ISTA) and the Bioprocessing Systems Alliance (BPSA)

https://www.smithersrapra.com/

 

 

Media Partners

PharmaVOICE magazine provides commentary about the challenges and trends impacting the life-sciences industry, covering a range of issues from molecule through market. PharmaVOICE's more than 25,000 BPA-qualified subscribers are also kept abreast of the latest trends through additional media resources, including WebSeminars, Podcasts, Videocasts, and White Papers.

SelectScience.net is the leading online product and application publication for laboratory scientists featuring the latest news, application articles, videos, product directory and product reviews. Membership is fast, free and provides access to all of the SelectScience services. SelectScience.tv is a unique video news channel for laboratory application and product information.

 

 

PharmiWeb.com is the leading jobs and news portal for the pharmaceutical, biotech and life sciences sector. Constantly updated with the latest events, features, news and thousands of jobs from all the leading employers in the sector. PharmiWeb.com is brought to you by innovative online publisher and e-business solutions provider, PharmiWeb Solutions.

 

Genetic Engineering & Biotechnology News (GEN)  is the most authoritative and widely read biotechnology news publication in the world.  Published 21 times a year, GEN's unique news and technology content  focus includes  the entire  bioproduct life cycle from early-stage R&D to applied  research and bioprocess through to commercialization. GENis  the only publication that  provides  the full  range of the biotechnology market coverage  in areas such as omics, drug and biomarker discovery, bioprocessing, clinical research, molecular diagnostics, and biobusiness.  For a free subscription, go to http://www.genengnews.com/subscriptions.aspx

 

 

Life sciences business intelligence firm Cutting Edge Information offers customized consulting and a growing library of targeted and insightful primary/secondary research reports that its competition cannot. Executives at more than 400 pharmaceutical and biotech firms have used Cutting Edge Information’s comprehensive, original pharmaceutical and benchmarking data and consulting services to make critical decisions on issues of both strategy and tactics.

 

GBI is an information, applications, and services company focused on the healthcare industry. Leveraging data from across the healthcare value chain, GBI creates web and mobile applications that enable individuals and organizations to make better decisions and communicate more effectively.

Hilton Hotel Kensington, Holland Park Avenue, W11 4UL, 

Expect a warm welcome the moment you arrive at Hilton London Kensington. Were're located in the leafy district of Holland Park, 30 minutes from Healthrow Airport, with excellent transport linksinto Central London and three different tube lines nearby.  Step inside the hotel and you'll find stylish rooms and suites, fantastic dining and first-class facilities for business and recreation everything you need for a remarkable stay in the capital.

HILTON_HOTEL_KENSINGTON

Phone:
 

Email:
info@lexicorp.co.uk

Accommodation is NOT included in the registration fee.

 

Registration Options 

There are various ways in which to register for a conference:-

  1. By Cheque made payable to: Lexicorp Ltd.  Send with completed booking  form to :Lexicorp Ltd, 160 Kemp House, City Road London, EC1V 2NX
  2. Bank Transfer: 
    Name Account:  LEXICORP LTD
    Name Bank:       BARCLAYS
    Address:            42 WELLFIELD ROAD CARDIFF CF24 3YR
    Account No: 73471853
    Account Sort Code: 201817
    IBAN:  IBAN GB32 BARC 2049 8113 0847 60
    Swift:   BARCGB22

 

Lexicorp Limited. Registered in England and Wales. Company number: 7526475

Registered office: 160 Kemp House, City Road, London, EC1V 2NX