SAN2014 Meeting

30 January 2014 - 02 February 2014

It is our great pleasure to welcome you to the conference website of the 2014 Meeting of the Society of Applied Neurosciences (SAN), jointly organized with the National Initiative Brain and Cognition (NIHC). The conference will be held from January 30th to February 2nd, 2014 in the Royal Dutch Jaarbeurs in Utrecht (The Netherlands). Confirmed keynote speakers include Niels Birbaumer, John Gruzelier, Pascal Fries, Katya Rubia and Thomas Schlaepfer. Further keynote and invited speakers will be announced later.

Royal Dutch Jaarbeurs, Utrecht, Netherlands

SAN2014 Meeting

30 January 2014 - 02 February 2014

It is our great pleasure to welcome you to the conference website of the 2014 Meeting of the Society of Applied Neurosciences (SAN), jointly organized with the National Initiative Brain and Cognition (NIHC). The conference will be held from January 30th to February 2nd, 2014 in the Royal Dutch Jaarbeurs in Utrecht (The Netherlands). Confirmed keynote speakers include Niels Birbaumer, John Gruzelier, Pascal Fries, Katya Rubia and Thomas Schlaepfer. Further keynote and invited speakers will be announced later.

Royal Dutch Jaarbeurs, Utrecht, Netherlands

Practical Applications of NMR in Industry Conference (PANIC)

03 February 2014 - 05 February 2014

Practical Applications of NMR in Industry Conference (PANIC) was initiated to provide an interactive forum for discussion of the latest developments in the use of NMR for practical applications to real problems faced by scientists in industry and research institutions. The emphasis is the practicality of the solution and “getting the job done”. The forum will provide a venue for presentation of practical applications, and workshops for discussion of real-world experiences relevant to current product development needs with an opportunity to share case studies to drive further development of NMR technology. Solution-state, solid-state, time-domain, and zero-field applications are all equally welcome at PANIC. The forum also will provide a venue for industrial, regulatory, government, and academic scientists to meet, network, and participate in exchanges of knowledge for mutual education in and advancement of the use of NMR techniques.

Hilton Charlotte University Place, Charlotte, NC, USA

Practical Applications of NMR in Industry Conference (PANIC)

03 February 2014 - 05 February 2014

Practical Applications of NMR in Industry Conference (PANIC) was initiated to provide an interactive forum for discussion of the latest developments in the use of NMR for practical applications to real problems faced by scientists in industry and research institutions. The emphasis is the practicality of the solution and “getting the job done”. The forum will provide a venue for presentation of practical applications, and workshops for discussion of real-world experiences relevant to current product development needs with an opportunity to share case studies to drive further development of NMR technology. Solution-state, solid-state, time-domain, and zero-field applications are all equally welcome at PANIC. The forum also will provide a venue for industrial, regulatory, government, and academic scientists to meet, network, and participate in exchanges of knowledge for mutual education in and advancement of the use of NMR techniques.

Hilton Charlotte University Place, Charlotte, NC, USA

Practical Applications of NMR in Industry Conference (PANIC)

03 February 2014 - 05 February 2014

Practical Applications of NMR in Industry Conference (PANIC) was initiated to provide an interactive forum for discussion of the latest developments in the use of NMR for practical applications to real problems faced by scientists in industry and research institutions. The emphasis is the practicality of the solution and “getting the job done”. The forum will provide a venue for presentation of practical applications, and workshops for discussion of real-world experiences relevant to current product development needs with an opportunity to share case studies to drive further development of NMR technology. Solution-state, solid-state, time-domain, and zero-field applications are all equally welcome at PANIC. The forum also will provide a venue for industrial, regulatory, government, and academic scientists to meet, network, and participate in exchanges of knowledge for mutual education in and advancement of the use of NMR techniques.

Hilton Charlotte University Place, Charlotte, NC, USA

Bioinformatics for Big Data: How Applications of Big Data will Drive Research Forward

10 February 2014 - 12 February 2014

Moscone North Convention Center, San Francisco, CA, USA

Parallel Trade

10^th – 11^th February 2014

Marriott Hotel Regents Park, London, UK

SMi’s 8th annual conference on Parallel Trade returns in 2014. The event will cover the latest regulation in the industry and offer guidance on compliance and best practice. Using data to manage parallel trade; anti-counterfeiting and competition law; building best practice processes; effective supply chain management; and differing perspectives from throughout the supply chain are just a selection of topics which will be featured. Leading pharmaceutical companies, legislative bodies and wholesalers will be speaking about their challenges and practical solutions to minimise loss and drive business performance. The event represents an excellent means for knowledge sharing and learning about case studies across the industry.

Senior management personnel will be speaking about their successes and analysing recent cases. This event promises to be a high quality practical event with plenty of opportunity for debate and offers you step-by-step guidance on the complex issue of parallel trade.

Key benefits to attend:

This 2 day event represents an excellent opportunity for delegates to hear from leading experts. Professionals from across the pharmaceutical industry and beyond will be in attendance. The diverse selection of speakers and delegates from around the world will give added value to this event, helping you manage your challenges and drive forward your solutions in a different and effective way. There will be unrivalled networking opportunities and space to reflect on your current business challenges.

Attend this event and learn the following:

• Understanding legal parallel trade and the non-licensed supply chain

• Challenge the differing perspectives on parallel trade

• How to use data to manage parallel trade

• Scrutinise effective supply chain management

• Analyse how to build best practice processes driven by the impact of parallel trade

New for 2014:

• How to comply with current and forthcoming pharmaceutical legislation

• Gain a diverse perspective on parallel trade from Johnson & Johnson Diabetes Solutions Companies

• Discuss the impact of government policies on parallel trade in Europe

• Perspective of traders – putting the spotlight on best practice within industry

• Kay panel discussion with LEO Pharma and Biogen Idec plus parallel trade industry experts Don Macarthur and Panos Kanavos

Key featured speakers:

• Craig Stobie, Global Life Sciences Sector Manager, Domino Uk Limited

• Dick Saunders, Commercial Manager, Johnson & Johnson Diabetes Solutions Companies

• Eric Noehrenberg, Director, Public Affairs for Market Access, Shire Pharmaceuticals Group Plc

• Hélène Juramy, Case Handler, European Commission

• Janice Haigh, Practice Leader, Market Access, Quintiles

• Joe Van Den Bergh, Director, Jeron Medical Limited

• Maarten Van Baelen, Medical Affairs Manager, European Generic Medicines Association

• Panos Kanavos, Reader, International Health Policy, London School of Economics and Political Science

• Dimitrios Karageorgiou, Secretary General, Panhellenic Pharmacists Association, Greece

What last year’s attendees said about the conference:

‘Good topics, up to date’ Novartis Pharma AG

‘Janice Haigh’s workshop was excellent’ Merck

‘Thought provoking, high energy and relevant’ Ernst and Young LLP

‘Very interesting, really good speakers’ AstraZeneca

Plus attend a half-day post – conference workshop:

Parallel Trade management strategies, hosted by Janice Haigh, Practice Leader, Market Access, Europe, Quintiles Consulting. Wednesday 12^th February, 8.30am – 12.30pm, Marriott Regents Park, London, UK.

Bioinformatics for Big Data: How Applications of Big Data will Drive Research Forward

10 February 2014 - 12 February 2014

Moscone North Convention Center, San Francisco, CA, USA

Parallel Trade

10^th – 11^th February 2014

Marriott Hotel Regents Park, London, UK

SMi’s 8th annual conference on Parallel Trade returns in 2014. The event will cover the latest regulation in the industry and offer guidance on compliance and best practice. Using data to manage parallel trade; anti-counterfeiting and competition law; building best practice processes; effective supply chain management; and differing perspectives from throughout the supply chain are just a selection of topics which will be featured. Leading pharmaceutical companies, legislative bodies and wholesalers will be speaking about their challenges and practical solutions to minimise loss and drive business performance. The event represents an excellent means for knowledge sharing and learning about case studies across the industry.

Senior management personnel will be speaking about their successes and analysing recent cases. This event promises to be a high quality practical event with plenty of opportunity for debate and offers you step-by-step guidance on the complex issue of parallel trade.

Key benefits to attend:

This 2 day event represents an excellent opportunity for delegates to hear from leading experts. Professionals from across the pharmaceutical industry and beyond will be in attendance. The diverse selection of speakers and delegates from around the world will give added value to this event, helping you manage your challenges and drive forward your solutions in a different and effective way. There will be unrivalled networking opportunities and space to reflect on your current business challenges.

Attend this event and learn the following:

• Understanding legal parallel trade and the non-licensed supply chain

• Challenge the differing perspectives on parallel trade

• How to use data to manage parallel trade

• Scrutinise effective supply chain management

• Analyse how to build best practice processes driven by the impact of parallel trade

New for 2014:

• How to comply with current and forthcoming pharmaceutical legislation

• Gain a diverse perspective on parallel trade from Johnson & Johnson Diabetes Solutions Companies

• Discuss the impact of government policies on parallel trade in Europe

• Perspective of traders – putting the spotlight on best practice within industry

• Kay panel discussion with LEO Pharma and Biogen Idec plus parallel trade industry experts Don Macarthur and Panos Kanavos

Key featured speakers:

• Craig Stobie, Global Life Sciences Sector Manager, Domino Uk Limited

• Dick Saunders, Commercial Manager, Johnson & Johnson Diabetes Solutions Companies

• Eric Noehrenberg, Director, Public Affairs for Market Access, Shire Pharmaceuticals Group Plc

• Hélène Juramy, Case Handler, European Commission

• Janice Haigh, Practice Leader, Market Access, Quintiles

• Joe Van Den Bergh, Director, Jeron Medical Limited

• Maarten Van Baelen, Medical Affairs Manager, European Generic Medicines Association

• Panos Kanavos, Reader, International Health Policy, London School of Economics and Political Science

• Dimitrios Karageorgiou, Secretary General, Panhellenic Pharmacists Association, Greece

What last year’s attendees said about the conference:

‘Good topics, up to date’ Novartis Pharma AG

‘Janice Haigh’s workshop was excellent’ Merck

‘Thought provoking, high energy and relevant’ Ernst and Young LLP

‘Very interesting, really good speakers’ AstraZeneca

Plus attend a half-day post – conference workshop:

Parallel Trade management strategies, hosted by Janice Haigh, Practice Leader, Market Access, Europe, Quintiles Consulting. Wednesday 12^th February, 8.30am – 12.30pm, Marriott Regents Park, London, UK.

Bioinformatics for Big Data: How Applications of Big Data will Drive Research Forward

10 February 2014 - 12 February 2014

Moscone North Convention Center, San Francisco, CA, USA

9th Annual Sales Force Effectiveness in Pharma

12 February 2014 - 14 February 2014

Vienna, Austria

9th Annual Sales Force Effectiveness in Pharma

12 February 2014 - 14 February 2014

Vienna, Austria

9th Annual Sales Force Effectiveness in Pharma

12 February 2014 - 14 February 2014

Vienna, Austria

Advances and Progress in Drug Design

17 February 2014 - 18 February 2014

This exciting event will focus on new approaches and will offer attendees the chance to hear from leading industry experts on lead optimisation strategies, SBDD, FBDD and phenotypic screening. SMi's annual conference on drug design in 2014 will provide attendees with a broad perspective on the industry and will focus on lead optimisation strategies, discussion of fragment based drug design, new approaches in structure based drug design and the role of water in drug design. This comprehensive event will bring together key industry experts to discuss, debate and share ideas and challenges facing the drug design arena.

Marriott Regents Park Hotel, London, UK

13th annual Advances and Progress in Drug Design

17th February to 18th February 2014, London, United Kingdom

SMi are proud to present the 13th annual Advances and Progress in Drug Design conference, convening in Central London on Monday 17 and Tuesday 18 February 2014. This exciting event will focus on new approaches and will offer attendees the chance to hear from leading industry experts on lead optimisation strategies, SBDD, FBDD and phenotypic screening.

SMi's annual conference on drug design in 2014 will provide attendees with a broad perspective on the industry and will focus on lead optimisation strategies, discussion of fragment based drug design, new approaches in structure based drug design and the role of water in drug design. This comprehensive event will bring together key industry experts to discuss, debate and share ideas and challenges facing the drug design arena.

Advances and Progress in Drug Design

17 February 2014 - 18 February 2014

This exciting event will focus on new approaches and will offer attendees the chance to hear from leading industry experts on lead optimisation strategies, SBDD, FBDD and phenotypic screening. SMi's annual conference on drug design in 2014 will provide attendees with a broad perspective on the industry and will focus on lead optimisation strategies, discussion of fragment based drug design, new approaches in structure based drug design and the role of water in drug design. This comprehensive event will bring together key industry experts to discuss, debate and share ideas and challenges facing the drug design arena.

Marriott Regents Park Hotel, London, UK

13th annual Advances and Progress in Drug Design

17th February to 18th February 2014, London, United Kingdom

SMi are proud to present the 13th annual Advances and Progress in Drug Design conference, convening in Central London on Monday 17 and Tuesday 18 February 2014. This exciting event will focus on new approaches and will offer attendees the chance to hear from leading industry experts on lead optimisation strategies, SBDD, FBDD and phenotypic screening.

SMi's annual conference on drug design in 2014 will provide attendees with a broad perspective on the industry and will focus on lead optimisation strategies, discussion of fragment based drug design, new approaches in structure based drug design and the role of water in drug design. This comprehensive event will bring together key industry experts to discuss, debate and share ideas and challenges facing the drug design arena.

Physiologically-Relevant Cellular Models for Drug Discovery

19 February 2014 - 21 February 2014

Traditional drug screening relies on monolayer cell culture, which is not always predictive of natural physiological state, where the complex microenvironment consists of various cell types that interact in 3-dimensional structures. As the cost of drug development rises, there is increasing pressure for more predictive in vitro models for functional analysis and compound characterization. Cambridge Healthtech Institute’s Inaugural Physiologically-Relevant Cellular Models for Drug Discovery meeting will focus on the latest advances in 3-D cellular models, complex co-culture systems, and simple model organisms for functional analysis studies and compound screening/characterization.

Marriott San Diego La Jolla, La Jolla, CA, USA

Physiologically-Relevant Cellular Models for Drug Discovery

19 February 2014 - 21 February 2014

Traditional drug screening relies on monolayer cell culture, which is not always predictive of natural physiological state, where the complex microenvironment consists of various cell types that interact in 3-dimensional structures. As the cost of drug development rises, there is increasing pressure for more predictive in vitro models for functional analysis and compound characterization. Cambridge Healthtech Institute’s Inaugural Physiologically-Relevant Cellular Models for Drug Discovery meeting will focus on the latest advances in 3-D cellular models, complex co-culture systems, and simple model organisms for functional analysis studies and compound screening/characterization.

Marriott San Diego La Jolla, La Jolla, CA, USA

Cell & Gene Therapy Conference

20 February 2014 - 21 February 2014

Treatment of disease using cell and gene therapy is now a reality. With emerging technologies and new clinical trials being developed and launched at a growing rate, this meeting will discuss the evolving regulatory challenges and pre-clinical requirements, the development and applications of cell and gene therapy, immune responses, as well as business model and commercial milestones.

Hyatt Regency Mission Bay San Diego, CA, USA

4th Ubiquitin Research and Drug Discovery Conference

Date: February 20-21, 2014

Venue: San Diego, CA

This premier conference will host an exciting group of professionals from the academic, biotech, pharmaceutical, and business communities, and will focus on drug discovery aspects within the ubiquitin pathway. A balance of both academic and industry experts will facilitate discussion on the following areas:

I. Deubiquitinating Enzymes as Drug Targets
II. Novel Drug Targets in the Ubiquitin System
III. Ubiquitin-like Modifications – New Opportunities
IV. Ubiquitin Pathways in Neurobiology
V. Ubiquitin Proteasome System and Oncology
VI. Proteasome Structure and Function

6th Ocular Diseases Drug Discovery Conference

Date: February 20-21, 2014

Venue: San Diego, CA

The conference continues to offer presentations on novel and innovative therapeutics in ocular drug development and discovery. This forum allows for excellent networking, the exchange of ideas, and sharing of challenges; all with a united common goal of bringing new and innovative treatments to patients in the area of ophthalmology.

The conference features the following topics:
Session: Novel Targets, Developments and Technologies
Session: Novel Drug Delivery Methods to the Anterior and Posterior Segments
Session: Clinical Development Advances & Updates
Session: Safety Assessment and Regulatory Landscape in Ocular Drug Development
Session: Short Presentations
Panel Discussion: BD, Investments and Potential for Collaborations
Panel Discussion: Safety and Regulatory in Ocular Development

The Ocular Diseases & Drug Development Conference promotes the discovery of ocular disease drug development by bringing together leading scientists, researchers and experts to discuss and collaborate on the latest research and development, safety assessment, regulatory issues and drugs in development for combating and curing age-related macular degeneration (AMD), diabetic retinopathy, glaucoma, DME, uveitis and other ocular diseases.

2nd Annual Corporate Compliance and Transparency in the Pharmaceutical Industry

20 February 2014 - 21 February 2014

Berlin, Germany

2nd Orphan Drugs Research & Commercialization Conference

20 February 2014 - 21 February 2014

We invite you to the 2nd Orphan Drugs Research & Commercialization Conference, happening February 20-21, 2014 in San Diego, CA. This meeting provides a forum for all stakeholders, from researchers, industry leaders, patient advocacy organizations, and regulatory experts to gather and share different perspectives on how to best guide the field forward. The program will include presentations on the latest scientific research, such as RNAi therapeutics and gene therapy; pricing and reimbursement challenges; clinical endpoints; and much more. Sessions for this year's meeting include: I. Emerging Therapeutics in Rare Diseases II. Engaging with All Stakeholders III. From the Clinic to the Markets IV. Overcoming Post-Approval Challenges

Hyatt Regency Mission Bay, San Diego, CA, USA

Physiologically-Relevant Cellular Models for Drug Discovery

19 February 2014 - 21 February 2014

Traditional drug screening relies on monolayer cell culture, which is not always predictive of natural physiological state, where the complex microenvironment consists of various cell types that interact in 3-dimensional structures. As the cost of drug development rises, there is increasing pressure for more predictive in vitro models for functional analysis and compound characterization. Cambridge Healthtech Institute’s Inaugural Physiologically-Relevant Cellular Models for Drug Discovery meeting will focus on the latest advances in 3-D cellular models, complex co-culture systems, and simple model organisms for functional analysis studies and compound screening/characterization.

Marriott San Diego La Jolla, La Jolla, CA, USA

Cell & Gene Therapy Conference

20 February 2014 - 21 February 2014

Treatment of disease using cell and gene therapy is now a reality. With emerging technologies and new clinical trials being developed and launched at a growing rate, this meeting will discuss the evolving regulatory challenges and pre-clinical requirements, the development and applications of cell and gene therapy, immune responses, as well as business model and commercial milestones.

Hyatt Regency Mission Bay San Diego, CA, USA

4th Ubiquitin Research and Drug Discovery Conference

Date: February 20-21, 2014

Venue: San Diego, CA

This premier conference will host an exciting group of professionals from the academic, biotech, pharmaceutical, and business communities, and will focus on drug discovery aspects within the ubiquitin pathway. A balance of both academic and industry experts will facilitate discussion on the following areas:

I. Deubiquitinating Enzymes as Drug Targets
II. Novel Drug Targets in the Ubiquitin System
III. Ubiquitin-like Modifications – New Opportunities
IV. Ubiquitin Pathways in Neurobiology
V. Ubiquitin Proteasome System and Oncology
VI. Proteasome Structure and Function

6th Ocular Diseases Drug Discovery Conference

Date: February 20-21, 2014

Venue: San Diego, CA

The conference continues to offer presentations on novel and innovative therapeutics in ocular drug development and discovery. This forum allows for excellent networking, the exchange of ideas, and sharing of challenges; all with a united common goal of bringing new and innovative treatments to patients in the area of ophthalmology.

The conference features the following topics:
Session: Novel Targets, Developments and Technologies
Session: Novel Drug Delivery Methods to the Anterior and Posterior Segments
Session: Clinical Development Advances & Updates
Session: Safety Assessment and Regulatory Landscape in Ocular Drug Development
Session: Short Presentations
Panel Discussion: BD, Investments and Potential for Collaborations
Panel Discussion: Safety and Regulatory in Ocular Development

The Ocular Diseases & Drug Development Conference promotes the discovery of ocular disease drug development by bringing together leading scientists, researchers and experts to discuss and collaborate on the latest research and development, safety assessment, regulatory issues and drugs in development for combating and curing age-related macular degeneration (AMD), diabetic retinopathy, glaucoma, DME, uveitis and other ocular diseases.

2nd Annual Corporate Compliance and Transparency in the Pharmaceutical Industry

20 February 2014 - 21 February 2014

Berlin, Germany

2nd Orphan Drugs Research & Commercialization Conference

20 February 2014 - 21 February 2014

We invite you to the 2nd Orphan Drugs Research & Commercialization Conference, happening February 20-21, 2014 in San Diego, CA. This meeting provides a forum for all stakeholders, from researchers, industry leaders, patient advocacy organizations, and regulatory experts to gather and share different perspectives on how to best guide the field forward. The program will include presentations on the latest scientific research, such as RNAi therapeutics and gene therapy; pricing and reimbursement challenges; clinical endpoints; and much more. Sessions for this year's meeting include: I. Emerging Therapeutics in Rare Diseases II. Engaging with All Stakeholders III. From the Clinic to the Markets IV. Overcoming Post-Approval Challenges

Hyatt Regency Mission Bay, San Diego, CA, USA

Quality by Design

24^th – 25^th February 2014

Marriott Hotel Regents Park, London, UK

Today more than ever regulatory guidance is increasingly focussing on the process robustness and product quality. The pharma world is also changing at an increasingly quickening pace. QbD philosophies must be quickly adapted for the development of any innovative products in order to ensure overall integrity.

QbD as a systematic approach enables products and process understanding and control, based on comprehensive science and quality risk management schemes. By understanding a product i.e. by formulation and processes in great detail, systematic approaches can be developed from an early stage to design quality into a product.

This year we will focus on how PAT plays a pivotal role in delivering the successful implementation of QbD validation. Practical case studies will be submitted associated with the potential pitfalls of practical applications, and how to avoid these hurdles. Practical approaches to QbD implementation in solid dosage forms and covering design as an end to end format.

2014 will see us focus on regulatory guidance from the FDA and MHRA and how we can deploy continuous process development - plant wide - into a previous operational plan.

Why attend this event:

• Employ QbD to design a formulation process. Harness raw material analysis and control strategy

• Utilise PAT tools and applications for pharmaceuticals, biopharmaceuticals and ATMPs

• Use risk assessment and management to best effect

• Accurately include QbD information in regulatory document filings, including those for ICH Q8 and ASTM E 2500

• Apply multivariate data analysis to maximise product development and patient outcomes

Key featured speakers:

• Julian Morris, Technical director, Centre for Process Analytics & Control Technology

• Andreas Schreiner, Head Validation Manufacturing Science & Technology, Novartis

• Marcel de Matas, Principal Scientist Formulation Science, AstraZeneca

• Frank Thielman, Operational Lead Inhalation New Solids, Novartis

• Martin Schubert, Head of Chemical Pharma Development, UCB

• Michel Ulmschneider, Senior Scientist, F Hoffman - La Roche A G

• Simeone Zomer, Technical Manager, GlaxoSmithKline

• Peter Boogaard, Director, Industrial Lab Automation

Plus an interactive half-day post-conference workshop: Successfully Implementing Quality by Design: An introductory Workshop QbD & PAT, hosted by Peter Boogaard, Founder, Industrial Lab Automation. Wednesday 26^th February 2014, 9.00am – 13.00pm, Marriott Hotel Regents Park, London, UK.

Quality by Design 24th February to 25th February 2014, London, United Kingdom

Today more than ever regulatory guidance is increasingly focussing on the process robustness and product quality. The pharma world is also changing at an increasingly quickening pace. QbD philosophies must be quickly adapted for the development of any innovative products in order to ensure overall integrity.

QbD as a systematic approach enables products and process understanding and control, based on comprehensive science and quality risk management schemes. By understanding a product i.e. by formulation and processes in great detail, systematic approaches can be developed from an early stage to design quality into a product.

This year we will focus on how PAT plays a pivotal role in delivering the successful implementation of QbD validation. Practical case studies will be submitted associated with the potential pitfalls of practical applications, and how to avoid these hurdles. Practical approaches to QbD implementation in solid dosage forms and covering design as an end to end format.

2014 will see us focus on regulatory guidance from the FDA and MHRA and how we can deploy continuous process development - plant wide - into a previous operational plan.

Quality by Design

24^th – 25^th February 2014

Marriott Hotel Regents Park, London, UK

Today more than ever regulatory guidance is increasingly focussing on the process robustness and product quality. The pharma world is also changing at an increasingly quickening pace. QbD philosophies must be quickly adapted for the development of any innovative products in order to ensure overall integrity.

QbD as a systematic approach enables products and process understanding and control, based on comprehensive science and quality risk management schemes. By understanding a product i.e. by formulation and processes in great detail, systematic approaches can be developed from an early stage to design quality into a product.

This year we will focus on how PAT plays a pivotal role in delivering the successful implementation of QbD validation. Practical case studies will be submitted associated with the potential pitfalls of practical applications, and how to avoid these hurdles. Practical approaches to QbD implementation in solid dosage forms and covering design as an end to end format.

2014 will see us focus on regulatory guidance from the FDA and MHRA and how we can deploy continuous process development - plant wide - into a previous operational plan.

Why attend this event:

• Employ QbD to design a formulation process. Harness raw material analysis and control strategy

• Utilise PAT tools and applications for pharmaceuticals, biopharmaceuticals and ATMPs

• Use risk assessment and management to best effect

• Accurately include QbD information in regulatory document filings, including those for ICH Q8 and ASTM E 2500

• Apply multivariate data analysis to maximise product development and patient outcomes

Key featured speakers:

• Julian Morris, Technical director, Centre for Process Analytics & Control Technology

• Andreas Schreiner, Head Validation Manufacturing Science & Technology, Novartis

• Marcel de Matas, Principal Scientist Formulation Science, AstraZeneca

• Frank Thielman, Operational Lead Inhalation New Solids, Novartis

• Martin Schubert, Head of Chemical Pharma Development, UCB

• Michel Ulmschneider, Senior Scientist, F Hoffman - La Roche A G

• Simeone Zomer, Technical Manager, GlaxoSmithKline

• Peter Boogaard, Director, Industrial Lab Automation

Plus an interactive half-day post-conference workshop: Successfully Implementing Quality by Design: An introductory Workshop QbD & PAT, hosted by Peter Boogaard, Founder, Industrial Lab Automation. Wednesday 26^th February 2014, 9.00am – 13.00pm, Marriott Hotel Regents Park, London, UK.

Quality by Design 24th February to 25th February 2014, London, United Kingdom

Today more than ever regulatory guidance is increasingly focussing on the process robustness and product quality. The pharma world is also changing at an increasingly quickening pace. QbD philosophies must be quickly adapted for the development of any innovative products in order to ensure overall integrity.

QbD as a systematic approach enables products and process understanding and control, based on comprehensive science and quality risk management schemes. By understanding a product i.e. by formulation and processes in great detail, systematic approaches can be developed from an early stage to design quality into a product.

This year we will focus on how PAT plays a pivotal role in delivering the successful implementation of QbD validation. Practical case studies will be submitted associated with the potential pitfalls of practical applications, and how to avoid these hurdles. Practical approaches to QbD implementation in solid dosage forms and covering design as an end to end format.

2014 will see us focus on regulatory guidance from the FDA and MHRA and how we can deploy continuous process development - plant wide - into a previous operational plan.

Next Gen: 8th Improving Bioavailabilty & Formulation Conference February 24-26, 2014, Philadelphia, PA

Strategies for Ensuring Optimum Solubility and Drug Viability

This summit investigates the core challenges to achieving maximum bioavailability in drug candidates as well as novel drug delivery solutions utilized to improve bioavailability, and expedite time-to-market of new chemical entities as well as reformulated therapeutics in the development pipeline.

For three days attendees will engage in workshops, panel discussions and case studies from distinguished representatives of companies such as Pfizer, Merck, Bristol-Myers Squibb, Astrazenenca, Regeneron and more.

Overall the main topics and themes to be discussed include:

• Ocular and Parenteral Drug Delivery
• Hot melt extrusion Technology/Spray-drying techniques
• High Throughput Robotics for Solubility Screening
• Lipid Excipients: how they work and when to use them
• Frequency Modulated Drug Delivery- bonds with metal to increase solubility and timed release of drug into tissue.
• Bioactive materials in nano-medicines
• Active vs Passive Targeting of Drug Delivery Systems

Next Gen: 8th Improving Bioavailabilty & Formulation Conference February 24-26, 2014, Philadelphia, PA

Strategies for Ensuring Optimum Solubility and Drug Viability

This summit investigates the core challenges to achieving maximum bioavailability in drug candidates as well as novel drug delivery solutions utilized to improve bioavailability, and expedite time-to-market of new chemical entities as well as reformulated therapeutics in the development pipeline.

For three days attendees will engage in workshops, panel discussions and case studies from distinguished representatives of companies such as Pfizer, Merck, Bristol-Myers Squibb, Astrazenenca, Regeneron and more.

Overall the main topics and themes to be discussed include:

• Ocular and Parenteral Drug Delivery
• Hot melt extrusion Technology/Spray-drying techniques
• High Throughput Robotics for Solubility Screening
• Lipid Excipients: how they work and when to use them
• Frequency Modulated Drug Delivery- bonds with metal to increase solubility and timed release of drug into tissue.
• Bioactive materials in nano-medicines
• Active vs Passive Targeting of Drug Delivery Systems

Next Gen: 8th Improving Bioavailabilty & Formulation Conference February 24-26, 2014, Philadelphia, PA

Strategies for Ensuring Optimum Solubility and Drug Viability

This summit investigates the core challenges to achieving maximum bioavailability in drug candidates as well as novel drug delivery solutions utilized to improve bioavailability, and expedite time-to-market of new chemical entities as well as reformulated therapeutics in the development pipeline.

For three days attendees will engage in workshops, panel discussions and case studies from distinguished representatives of companies such as Pfizer, Merck, Bristol-Myers Squibb, Astrazenenca, Regeneron and more.

Overall the main topics and themes to be discussed include:

• Ocular and Parenteral Drug Delivery
• Hot melt extrusion Technology/Spray-drying techniques
• High Throughput Robotics for Solubility Screening
• Lipid Excipients: how they work and when to use them
• Frequency Modulated Drug Delivery- bonds with metal to increase solubility and timed release of drug into tissue.
• Bioactive materials in nano-medicines
• Active vs Passive Targeting of Drug Delivery Systems