2nd Annual Bioequivalence and Bioavailability Studies - Full Agenda LEARN MORE http://www.bioequivalenceevent.com/redForms.aspx?id=532198&pdf_form=1?&shownewswindow=1&utm_source=PharmaIQ&utm_medium=SMO&mac=PMIQ_Slideshare&utm_campaign=Slideshare&utm_term=pdf

1. presents the 2nd Annual Register and pay before 24th June and save up to €450
Bioequivalence
BioavailabilityStudies
Two Day Conference: 20th – 21st September 2011
&
Pre-Conference Workshop Day: 19th September 2011
Location: Four Points by Sheraton, Brussels, Belgium
Speed time to market by ensuring regulatory compliance, biowaiver approval
and successful bioequivalence studies for modified release products
The only event in Europe that will help you to: Don’t miss the opportunity
to engage with top European
Explore strategies to ensure compliance and speed time to regulators including:
market: Tamás Paál, National Institute for Pharmacy
Christoph Baumgärtel, Head of Department,
Directorate and Kevan Cassidy, Rosemont Pharmaceuticals Safety and Efficacy Assessment of Human
discuss the EMA bioequivalence guidelines one year on Medicinal Products, AGES, Austria
Save development time and speed approval through successful Tamás Paál, Senior Advisor, National
Institute for Pharmacy Directorate,
biowaiver applications, gain expert guidance from Ivana Hungary
Taševská, State Institute for Drug Control Marcus Savsek, Pharmaceutical Assessor,
Ensure you have the correct strategies in place to comply BfArM, Germany
with the draft modified release guidelines: unravel the key Ivana Taševská, Pharmaceutical Assessor,
Department of Pharmaceutical Evaluation,
changes and the implications for industry with Christoph State Institute for Drug Control,
Baumgärtel, AGES Czech Republic
Implement effective modelling and simulation tools to translate Along with a wealth of industry
bioequivalence results into clinical relevance with an exclusive case case studies, including:
study from Thomas Kerbusch, Merck/MSD Marcus Brewster, Distinguished Research
Perfect your comparative study design to ensure first time Fellow, Pharmaceutical Research, Johnson
& Johnson, Belgium
approval with expert advice from Sandra van Os, Synthon Kevan Cassidy, Clinical Director, Rosemont
Pharmaceuticals, UK & Co-chair, EGA
Pre-Conference Workshop Day: 19th September Bioequivalence Working Group
Don’t miss out on our interactive pre-conference workshop day – these workshops Jiri Hofmann, Clinical Development Manager,
represent a unique opportunity to discover essential solutions to establishing the Zentiva, Sanofi-Aventis Group,
optimal solubilising delivery techniques, gain expert advice on using biowaivers in Czech Republic
practice and understanding biostatistical relevance of variability in 2 stage Thomas Kerbusch, Senior Director
approaches. Engage in hands-on practical sessions led by: (Technical Lead Innovation, Implementation &
Marcus Brewster, Distinguished Jean-Michel Cardot, Department Impact of M&S), Merck, Sharp & Dohme,
Research Fellow, Pharmaceutical of Biopharmaceutics and the Netherlands
Research, Johnson & Johnson, Pharmaceutical Technology,
Belgium University d’Auvergne, France Filippos Kesisoglou, Research Fellow,
Merck & Co, US
Anders Fuglsang, Consultant, Helmut Shütz, CEO,
FuglsangPharma, Germany BEBAC, Austria Sandra van Os, Head of Clinical Operations,
Synthon BV, the Netherlands
Vit Perlik, Senior Clinical Development
Interactive Formats: get involved in our lively regulatory panel Manager, Zentiva, Sanofi-Aventis Group,
discussion, get down to the root of the problem with our focused Czech Republic
roundtable sessions and learn what is really happening from your Jean-Michel Cardot, Department of
peers during our extended networking session Biopharmaceutics and Pharmaceutical
Technology, Université d’Auvergne, France
Anders Fuglsang, Consultant,
What past attendees have said about this event: Fuglsang Pharma, Denmark
“Very good to hear the assessors views on the matter.” Abbott Helmut Schütz, Director, BEBAC, Austria
+44 (0)20 7368 9300 www.bioequivalenceevent.com ENQUIRE@IQPC.CO.UK

2. Pre-Conference Workshop Day Monday 19th September 2011
Maximising the Efficiency of Bioequivalence & Bioavailability Studies through
Biowaiver Applications, Improved Drug Delivery Systems and Bioanalytical Guidance
Setting up a BE study: from design to approval
By attending this workshop, participants will discover how to successfully plan and perform bioequivalence studies.
You will come away with a greater understanding of:
A • The history of bioequivalence testing: lessons from the past which have influenced modern-day studies
• Current bioequivalence study strategies: which study design and when?
• The role of noncompartmental analysis (NCA) in pharmacokinetics and PK-based study design
• Best practice in statistical design and analysis
Helmut Schütz, CEO, BEBAC, Austria 10.30 – 13.30
Approaches for drug solubilisation
By attending this interactive workshop, participants will gain in-depth insights into the aspects of formulating poorly water-soluble drug
candidates and the use of solubilising drug delivery technologies.
You will come away with expert guidance on:
• Preformulation approaches for determining the extent of enablement needed to engender useful oral bioavailability for
a poorly soluble drug candidate
B • Assays to provide information on drug candidate biopharmaceutical fitness
• Decision trees on solubilising technique and where they add the most value for both new compounds as well as life-cycle
management opportunities
• Overview of currently marketed solubilising drug delivery systems including but not limited to the use of cyclodextrins,
nanosuspension and related dosage forms and solid dispersions
• Hybrid technologies and drug-device combinations for poorly water-soluble drugs
• Developmental considerations including impacts on cost, quality and cycle time
• Potential technologies that may impact future applications and horizon-scanning approaches
Marcus Brewster, Distinguished Research Fellow, Pharmaceutical Research, Johnson & Johnson, Belgium 10.30 – 13.30
Power and intra-subject variability in 2 stage approaches
to bioequivalence approval
C Details to be released shortly.
Visit www.bioequivalenceevent.com for further updates.
Helmut Schütz, CEO, BEBAC, Austria & Anders Fuglsang, Consultant, FuglsangPharma, Germany 14.30 – 17.30
Biowaivers in practice: understanding the practicalities of biowaivers
and harnessing their time and cost saving benefits
By attending this hands-on workshop, participants will identify and overcome the obstacles to securing a biowaiver.
You will come away with further clarification on:
D • What a biowaiver is
• Differences between biowaivers and surrogates of in vivo studies
• Types of biowaivers
• Practical applications
- In drug development
- For generics
- BCS biowaivers - Limitations of biowaivers
- IVIVC based biowaivers • Legal points in the EU and US
Jean-Michel Cardot, Department of Biopharmaceutics and Pharmaceutical Technology,
University d’Auvergne, France
14.30 – 17.30
+44 (0)20 7368 9300 www.bioequivalenceevent.com ENQUIRE@IQPC.CO.UK

3. Conference Day 1 Tuesday 20th September 2011
08.15 Registration and Coffee 14.20 The role of BCS in drug development programmes
• Use of BCS, DCS and BCDDS in compound selection and early testing
09.00 Pharma IQ’s Welcome and Opening Remarks from Chairperson
CASE • Biopharmaceutical assessments and BCS
GETTING TO GRIPS WITH THE BIOEQUIVALENCE STUDY • Expert case studies showcasing successful use of BCS in
GUIDELINES TO ENSURE FIRST TIME APPROVAL drug development
09.10 Industry experience with the EMA bioequivalence guideline Marcus Brewster, Distinguished Research Fellow,
• Has the bar for generic entry been raised? Pharmaceutical Research, Johnson & Johnson, Belgium
CASE • Practical examples of successful use of the updated guidelines 15.00 Networking Refreshment Break
STUDY • The industry wish-list: highlighting the opportunities and limitations
of the guidelines and what industry wants to see in the future 15.30 REGULATORY PANEL DISCUSSION: Your chance to ask all of your
crucial questions and get the answers you need.
INTERACTIVE
Kevan Cassidy, Clinical Director, Rosemont Pharmaceuticals,
UK & Co-Chair, EGA Bioequivalence Working Group In this session, participants will have the opportunity to ask regulators
specific questions about guidance including compliance issues,
09.50 The new EMA bioequivalence guideline one year on: biowaiver applications, FDA guidelines, bioanalysis and modified release
a regulatory perspective products. The panel will address the key regulatory considerations,
REGULATOR
• Clearing the confusion: key areas of misunderstanding practical approaches and time saving solutions to planning, conducting
• Useful strategies to ensure compliance and speed time to market and submitting your studies.
• Ensuring drug safety: CMD(h) referrals in 2010 Tamás Paál, Senior Advisor, National Institute for Pharmacy
Tamás Paál, Senior Advisor, National Institute for Pharmacy Directorate, Hungary
Directorate, Hungary Marcus Savsek, Pharmaceutical Assessor, BfArM, Germany
10.30 Extended Networking & Refreshments Ivana Taševská, Pharmaceutical Assessor, Department of
Bring plenty of business cards to exchange in a series of one-on-one Pharmaceutical Evaluation, State Institute for Drug Control,
INTERACTIVE
meetings with your fellow attendees. Your mission - discuss one of the Czech Republic
following things with each person you meet: ASSESSING AND EVALUATING THE ROLE OF IVIVC
1. Biggest challenge in bioequivalence testing IN BIOEQUIVALENCE
2. Outsourcing strategies: choosing your CRO
3. Biowaiver success stories
16.10 Application of IVIVC to bioequivalence testing
• Reducing time and money: predicting bioequivalence from in vitro
11.20 An overview of the EU guideline on the validation of dissolution tests
bioanalytical methods • Internal versus external validation of IVIVC: ensuring success of
REGULATOR
• Understanding the differences between the EU and US your model
• Highlighting the typical areas of non-compliance and strategies • Role of IVIVC in generic drug product development and approval
to avoid these pitfalls Jean-Michel Cardot, Department of Biopharmaceutics and
• Integration with the principles of GLP Pharmaceutical Technology, University d’Auvergne, France
• Lessons from Crystal City: how to handle incurred sample reanalysis
Marcus Savsek, Pharmaceutical Assessor, BfArM, Germany
16.50 Closing Remarks from Chairperson and End of Day One
SUCCESSFULLy IMPLEMENTING QBD
12.00 PANEL DISCUSSION: Applying Quality by Design principles
to BE/BA studies
In this session, participants will have the opportunity to ask specific
questions regarding the application of QbD to BE/BA studies. The panel
will address key issues including: Does quality by design add value to
BE/BA studies? How to identifying and overcome the specific issues of
applying QbD to biogeneric drug development, how to successfully
implement quality by design and achieve optimal results
12.40 Networking Lunch
EFFECTIVE APROACHES TO BIOWAIVER SUCCESS
13.40 Tips from the regulators for successfully securing a biowaiver
What others have said
• Interpreting the guideline and understanding the approval process about Pharma IQ events:
REGULATOR
to maximise biowaiver application success
• Successful use of analytical methods to secure a biowaiver “Great mix of presenters
• Improving first time approval: understanding what is and what
isn’t eligible covering a comprehensive
Ivana Taševská, Pharmaceutical Assessor, Department of
Pharmaceutical Evaluation, State Institute for Drug Control,
range of topics-well done.
Czech Republic Superb networking opportunity.”
Pfizer
+44 (0)20 7368 9300 www.bioequivalenceevent.com ENQUIRE@IQPC.CO.UK

4. Conference Day 2 Wednesday 21st September 2011
08.15 Registration and Coffee C) Dealing with combination and highly variable products
In a market where drug development is moving further away from simple
08.50 Pharma IQ’s Welcome and Opening Remarks from Chairperson
compounds, this session provides an opportunity to evaluate the
INVESTIGATING BEST PRACTICE IN STUDy DESIGN challenges of developing combination and highly variable products.
TO SPEED TIME TO MARKET Topics for discussion include: further clarification of the EU and US
stance on scaling, why do we worry about outliers? Justification of fixed
09.00 Perfecting the two stage study design
dose combinations (FDC) and current thinking on data exclusivity of FDC
• What are the benefits of using a two stage design?
Vit Perlik, Senior Clinical Development Manager, & Jiri Hofmann,
• Successfully controlling type 1 error rate
Clinical Development Manager, Zentiva, Sanofi-Aventis Group,
• Challenges and solutions for determining optimal sample size
Czech Republic
• Replicate designs: can they be combined with two stage designs?
• Case examples of two stage studies 12.50 Networking Lunch
Helmut Schütz, CEO, BEBAC, Austria
13.50 Challenges in the design of comparative bioavailability studies:
09.40 Bioequivalence approaches to highly variable drugs and experiences from industry
highly variable drug products CASE • Parent drug or metabolite?
• Reference scaling versus widening of the confidence intervals STUDY • Cross over or parallel design?
• EMA position on the evaluation of replicate studies • Patients vs. volunteers?
• Dealing with outliers: use of outlier checks and understanding - High variability
when and why outliers should be excluded - Pilot studies
Jiri Hofmann, Clinical Development Manager, Zentiva, Sanofi-Aventis Sandra van Os, Head of Clinical Operations, Synthon BV,
Group, Czech Republic the Netherlands
10.20 Networking Refreshment Break EFFECTIVE MODELLING, SIMULATION AND DISSOLUTION
TOOLS TO ESTABLISH BIOEQUIVALENCE
10.50 Seeking approval for nasal hybrids/generics: don’t try this
at home! 14.30 Translating (non-) bioequivalence results to clinical (IR)
• Regulatory situation in EU and US relevance through integrated modelling and simulation of
• Relevance of a stepwise approach to approval in EU CASE PK/PD- efficacy/safety
• Pitfalls associated with PK and PD evaluations STUDY • Regulatory aspects of modelling and simulation
Anders Fuglsang, Consultant, FuglsangPharma, Germany • Models to link pharmacokinetics to pharmacodynamics to efficacy
and safety
11.30 Combination products: why do we combine and what are the • Simulating clinical relevance of PK findings
implications for bioequivalence studies? • Leveraging competitor data
CASE • Understanding the legal framework
STUDY
• Examples from industry
• Fixed dose combinations – space for innovation?
Thomas Kerbusch, Senior Director, Technical Lead Innovation,
• Examples of clinical development strategies for combination products
Implementation & Impact of Modeling & Simulation, Merck/MSD,
Vit Perlik, Senior Clinical Development Manager, Zentiva,
the Netherlands
Sanofi-Aventis Group, Czech Republic
15.10 Networking Refreshment Break
12.10 BREAKOUT ROUNDTABLE DISCUSSIONS:
Participants will be able to choose one of the roundtables outlined 15.40 Optimising dissolution testing
below and spend 40 minutes discussing the points: • Modelling and simulation approaches to determine dissolution rates
• Assessing impact of dissolution on bioavailability
A) Regulatory expectations and submission criteria • Moving from dissolution studies to BE/BA studies
Delegates will have the opportunity to discuss challenges and solutions
Filippos Kesisoglou, Research Fellow, Merck & Co, US
for maximising biowaiver success directly with the regulators.
Topics discussed will include: where, when and how to apply for a ENSURING EFFECTIVE BIOEQUIVALENCE STUDIES FOR
biowaiver, regulatory expectations, submission criteria, examples of MODIFIED RELEASE PRODUCTS
successes and failures. 16.20 Development of modified release guidelines
Ivana Taševská, Pharmaceutical Assessor, Department of • Overview of current guidelines
REGULATOR
Pharmaceutical Evaluation, State Institute for Drug Control, • Understanding the key changes and what it will mean for industry
Czech Republic • Regulatory expectations and submission criteria
B) Simulating dissolution profiles Christoph Baumgärtel, Head of Department, Safety and Efficacy
This discussion will examine the latest modelling and simulation tools Assessment of Human Medicinal Products, AGES, Austria
and provide practical advice on how to use the generated profiles to 17.00 Closing Remarks from Chairperson and End of Conference
establish bioequivalence in vitro. Topics discussed will include: the
role of simulation in determining IVIVC, integrating dissolution profiles
into development strategies and examples of successes and failures.
Filippos Kesisoglou, Research Fellow, Merck & Co, US
+44 (0)20 7368 9300 www.bioequivalenceevent.com ENQUIRE@IQPC.CO.UK

5. About the Event
TOP 10 REASONS TO ATTEND
1. Receive regulatory clarification of the bioequivalence 6. Overcome the challenges of establishing bioequivalence
submission criteria to ensure compliance and speed for highly variable drugs
time to market
7. Address the implications for industry of the draft
2. Be prepared for the new modified release guidelines bioanalytical guidelines
3. Make informed decisions before starting your studies 8. Translate results to clinical relevance using modelling and
through effective use of in vitro testing and establishing IVIVC stimulation tools
4. Optimise study design by understanding the two stage approach 9. Interactive roundtable sessions - gain further in-depth
knowledge in your chosen subject area
5. Successfully secure a biowaiver with tips from the regulators
and clarification of the biopharmaceutical classification system 10. Interact and network with your colleagues and peers in
our dedicated networking sessions!
Media partners
Who Should Attend •
•
Clinical Pharmacology
PKPD
•
•
Analytical Science
Analytical R&D
Directors, senior managers and managers within • Clinical Development • Regulatory Affairs
pharmaceutical manufacturers, biotech and generics • Clinical Operations • Principal and Senior Scientists
companies and academic institutes with responsibility for: • Pre/Formulation
Maximise your Involvement:
Sponsorship and Exhibition Opportunities
The Pharma IQ Bioequivalence and Bioavailability Studies conference
About Pharma IQ will be the perfect platform for service providers to meet senior-
Continue your learning experience with Pharma IQ online. As level decision makers in the pharmaceutical/biopharmaceutical
well as playing host to a series of global events where leading and generics industry who are looking for solutions and services
industry experts and thought leaders share their experience, to improve efficiency of bioequivalence and bioavailability testing.
knowledge and strategic thoughts, Pharma IQ also offers an Contact Pharma IQ to discuss how to position your company in
online community for pharma & biotech professionals. Join now front of your participants who are keen to learn more about today’s
to network with your peers and access exclusive videos, podcasts technologies and services including Merck/MSD, Synthon BV,
and presentations from this and other Pharma IQ events. Rosemont Pharmaceuticals, Johnson & Johnson, Zentiva and many
more. For more information on the sponsorship opportunities
Join the community: http://Pharma-IQ.com/join.cfm
available please email sponsorship@iqpc.co.uk or phone
+44 (0) 207 368 9300.
+44 (0)20 7368 9300 www.bioequivalenceevent.com ENQUIRE@IQPC.CO.UK

6. Bioequivalence
BioavailabilityStudies & 5 Ways to Register
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Two Day Conference: 20th – 21st September 2011
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