1. Program
30th
April - 1st May 2013
Manchester Grand Hyatt,
San Diego, USA
Researched and Produced by:

2. DAY 1, 30th April 2013 (Tuesday)
REGISTRATION AND BREAKFAST
CHAIR'S WELCOME ADDRESS
Keith Horspool, Ph.D.
VP, Pharmaceutical Development
Boehringer Ingelheim
OVERCOMING THE PATENT CLIFF
Lifecycle Management - Paradigm Shifts Toward More Effective Development and Commercialization
r Comparing and contrasting the development model of today to that of 10 years ago
r Examining roadblocks toward game changing innovation and delivery routes
r Overcoming the patent cliff and maintaining a competitive edge over generics
r Improving clinical trial timelines - why is it taking so long?
r Helping scientists, formulation and development teams become highly efficient
Riccardo Panicucci, Ph.D.
Global Head, Chemical and Pharmaceutical Profiling
Novartis
ACADEMIC-GOVERNMENT PARTNERSHIPS
Bioavailability and Solubility - Improving Sustained Release Formulations through Nanotechnology
r Developing high absorption and sustained release formulations that last from 24 hours to 1 week
r New hydro gels and macroscopic dosage forms - exploring applications to HIV/AIDS and cancer medicines
r Developing methods for the design, fabrication and evaluation of drug and diagnostic delivery technologies
r Looking internationally for ground breaking research in stability and commercial scale-up
r Where will nanotechnology be in the next 5 years? - Steps to formulating Class 4 drugs
Fatih M. Uckun, M.D., Ph.D.
Professor, Research Pediatrics at Children's Center for Cancer and Blood Diseases, Children's Hospital Los Angeles
University of Southern California
Patrick J. Sinko, Ph.D.
AVP, Research and Professor II in the Ernest Mario School of Pharmacy
Rutgers University
Peter S. Kim, M.D.
Deputy Director, Therapeutics Research Program
National Institutes of Health
Piotr Grodzinski, Ph.D.
Director, NCI Office of Cancer Nanotechnology Research
National Cancer Institute
INTERACTIVE WORKSHOP
Techniques for Enabling Better Treatments through Oral Drug Delivery
Keeping up with industry pressures to bring more drugs to market and faster
Enabling the development of better treatments through proven technologies and
techniques
INTERACTIVE WORKSHOP
First-in-Human Formulation Strategies - New Paradigms Challenging the Status Quo
Assessing formulation and manufacturing techniques available to development teams
Understanding the drawbacks and benefits of preclinical, in vitro and in silico methods
Translational Pharmaceutics - What is it? How can it help?
07:30-08:00
08:00-08:05
08:05-08:40
08:40-09:25
09:25-10:00

3. Enhancing solubility through modifying release profiles of oral drug delivery formulations
Michael Valazza
VP, Business Development
Catalent Pharma Solutions
Case studies on Enabled First-in-Human studies
Mark Egerton, Ph.D.
Managing Director
Quotient Clinical
PRE-ARRANGED ONE-TO-ONE MEETINGS AND REFRESHMENTS
SMALL MOLECULE - API CHARACTERIZATION
Case Study: One-Year Progress Report on Initiatives to Further Integrate API
Characterization in Development
r Applying predictive and simulation modeling in formulation and delivery
r Utilizing particle engineering and predictive pharmaceutical modeling to predict form
and performance
r Exploring how to best capture early phase data, analyze and forward screen to assess
risk
r Readily accessing necessary tools for data comparison in development - The
Cambridge Crystal Database
r Balancing the challenge of becoming smarter and faster while maintaining compliance
Val Harding, Ph.D.
VP, Global Pharmaceutical Science R&D
Pfizer
BIOLOGICS - ANTI-CANCER AND ANTI-FIBROTIC THERAPIES
Case Study: Rapid Establishment of Biologics at Gilead Sciences
r Building a biologics portfolio from the ground-up to advance Gilead's product pipeline
r Addressing the challenges and benefits of operating in a small group with end-to-end
CMC responsibilities
r Improving tech transfer from process development to clinical drug substance and drug
product fill/finish operations
r Case studies on antibody production and managing complex relationships with external
partners
Scott Sellers, Ph.D.
Senior Research Scientist II, Biologics Development
Gilead Sciences
INTERACTIVE WORKSHOP
Capitalizing on Microfluidic Technology to Enhance Drug Formulations
r Utilizing new technologies to determine the process variables of drug formulations
r Developing drug delivery formulations with a high degree of uniformity, solubility, tailored
release, benign processes and reproducibility
r Combining all process critical equipment into one compact and robust apparatus that is
easy to control and ready to use in environments that meet pharmaceutical standards
Robin de Bruijn
Founder & CTO
EmulTech
INTERACTIVE WORKSHOP
Overcoming the Solubility Hurdle and Reducing Time to Market
Transforming Class 2 and 4 compounds into usable Class 1 drugs through the
deployment of the NanoActive Technology
Implementing high throughput screening cascade to generate hits within days
Predicting in-vivo performance of Super-APIs from well-established in-vitro assays
Establishing development and optimization process - focusing on final dosage from
compatibility
Examining fully industrialized production process from discovery application to cGMP
production scale
Katalin Ferenczi
Principal Business Development Manager
Druggability Technologies Holdings
SMALL MOLECULE - HUMAN VS. ANIMAL PRODUCT DEVELOPMENT
Lessons to be learnt from Animal Health Development
r What unique safety goals must be met for animal health products?
r What are the parameters that animal product formulators have to reach?
r Comparing and contrasting human and animal health product development timelines
r New opportunities for novel, cost-effective delivery technologies for animal health
products
James E. Freeman
VP, Laboratory Sciences, Veterinary Medicine R&D
Zoetis
Martin Folger, Ph.D.
Head, Pharmaceutical Development
Boehringer Ingelheim Vetmedica GmbH
Robert Waranis, Ph.D.
Head, Formulation Development and Pharmaceutical Technology
Merial, a Sanofi company
BIOLOGICS - PK/PD STUDIES OF HIGH DOSE FORMULATIONS
Case Study: Assessing Immunogenicity in Single Dose and Multiple Dose Studies
Why is immunogenicity observed in a fraction of individuals and not all the population?
Does high dose formulation induce immune tolerance?
Examining the impact of immunogenicity on PK profiles of large molecules
Understanding responses to strength, onset and longevity and its impact on PK studies
Comparing and contrasting clearance of novel drug constructs compared to full human
monoclonal antibodies
Addressing the need for a universal method to overcome inconsistencies in reporting
types of ADA responses that impact PK/PD
Vibha Jawa, Ph.D.
Principal Scientist, Clinical Immunology
Amgen
10:00-11:45
11:45-12:20
12:20-12:55
12:55-13:30
13:30-14:30

4. NETWORKING LUNCH
PANEL DISCUSSION - IMPROVING DEVELOPMENT RELATIONSHIPS
Reducing Costs and Risk in Drug Development Partnerships
r Overcoming hurdles of partner communication and data management
r Balancing partnerships in early drug development with measures to minimize risk
r How do we better manage the development lifecycle and risk sharing with partners?
MODERATED BY
Elizabeth Thomas
Editor
American Pharmaceutical Review, Pharmaceutical Outsourcing
Frank Diana, Ph.D.
VP, Pharmaceutical Development
Endo Pharmaceuticals
Jessica Ballinger
Senior Director, Protein Pharmaceutical Development
Biogen Idec
Keith Horspool, Ph.D.
VP, Pharmaceutical Development
Boehringer Ingelheim
Riccardo Panicucci, Ph.D.
Global Head, Chemical and Pharmaceutical Profiling
Novartis
BIOLOGICS - IMPROVING M&S CAPABILITIES
Model-Based Quantitative Approaches in Formulation Development - Pushing the
Envelope of Regulatory Acceptance
r Examining "near-miss" translation of BE results
r Using PK/PD models to predict the effect on clinical outcome in situations of minor
excursion beyond BE bounds
r Case studies - leveraging data to predict the effect of Cmax excursion on the clinical
outcome
r Assessing regulatory responses: Successes and failures to convince regulators
Thomas Kerbusch, Ph.D.
Executive Director, Modeling and Simulation
Merck & Co.
INTERACTIVE WORKSHOP
Enhancing Solubility through the Micronization (Nanonization) of API
r Exploring opportunities, challenges and applications for Micronization (Nanonization) of
API
r Understanding the fundamentals and methodology of utilizing 'Bead Mills' to increase
the solubility of API
r NETZSCHE DeltaVita®: Critical design parameters and units available
r Real world applications utilizing Micronization of API to nanoscale
Randall Smith
President
NETZSCH Premier Technologies
INTERACTIVE WORKSHOP
Rapid Trace Impurity Control and Resolution
r Understanding the sources of unqualified trace impurities
r Approaches to impurity structure elucidation and identification
r Case study: Screening for unqualified impurities in late-stage product
r Navigating roadblocks to correct and control impurities or degradant formation
Clare L. Murray, Ph.D.
Director, Integrated Pharmaceutical Solutions
Scynexis
PRE-ARRANGED ONE-TO-ONE MEETINGS AND REFRESHMENTS
SMALL MOLECULE - PROCESS VALIDATION AND TECH TRANSFER
Best Strategies for Commercialization and Rapid Product Introduction
r How can drug development and manufacturing groups work together to correct
inefficiencies in technology transfer?
r Avoiding roadblocks in the process - what are the preferred techniques?
r Integrating development and manufacturing teams to reduce time to market
r Overcoming process validation challenges for technology transfer
Shabbir Anik, Ph.D.
SVP, Technical Operations
Onyx Pharmaceuticals
BIOLOGICS - VACCINE TECHNOLOGIES AND DEVELOPMENT
Creating Universal Vectors for Therapeutic Recombinant Viral Vaccines
r Case study - Phase 1 human clinical results of genetically modified killed whole-HIV
vaccine
r Prime-boost vaccine development using two different serotypes of recombinant
vesicular stomatitis viruses
r Developing therapeutic vaccines to clear chronic HCV infection, and asymptomatic HIV-
positive patients
r Examining cellular immune responses against HIV and HCV proteins
Chil-Yong Kang, Ph.D.
14:30-15:05
15:05-15:40
15:40-17:00
17:00-17:35

5. DAY 2, 1st May 2013 (Wednesday)
Professor of Virology, Department of Microbiology and Immunology
Western University
KEYNOTE PRESENTATION - CONTINUOUS MANUFACTURING
Continuous Manufacturing in Pharma - Advancing Science and Technology to Improve Product Development
Implementing a strategy for continuous processing for formulated products
Assessing new technologies, operational impacts, trends and drivers
Addressing the challenges and benefits of continuous processing
What facility designs are required for successful deployment for continuous manufacturing?
Discussing the application of continuous processing with a QbD framework
Matthew Ling, Ph.D.
Manager, Continuous Manufacturing, Formulation Sciences Group
AstraZeneca
CHAIR'S CLOSING REMARKS
Keith Horspool, Ph.D.
VP, Pharmaceutical Development
Boehringer Ingelheim
NETWORKING DRINKS RECEPTION
Sponsored by
NETWORKING AND BREAKFAST
CHAIR'S OPENING REMARKS AND REVIEW OF DAY ONE
Keith Horspool, Ph.D.
VP, Pharmaceutical Development
Boehringer Ingelheim
KEYNOTE PRESENTATION - PROCESS OPTIMIZATION AND LIFECYCLE MANAGEMENT
Driving a Culture of Innovation to Break Past Development Barriers and Formulate Products for Unmet Medical Needs
r Examining milestones of formulation and drug delivery key to MedImmune's success
r Gaining a competitive edge on the competition through utilizing drug delivery technologies
r Uncovering future trends for the development and application of prefilled syringes and other devices
r Finding new technologies that enable lifecycle management opportunities
Andrew Donnelly, Ph.D.
Head, Drug Delivery and Device Development, Formulation Sciences
MedImmune
SMALL MOLECULE - DEVELOPMENT BEST PRACTICES BIOLOGICS - TRENDS IN BIOSIMILAR DEVELOPMENT AND
REGULATORY PATHWAY
17:35-18:10
18:10-18:15
18:15-19:15
07:30-08:00
08:00-08:10
08:10-08:45
08:45-09:20

6. From Basic Research to Market Introduction - Setting Best Practices to Enhance
Productivity and Efficiency
r Working as a team to improve organizational development to solve drug delivery and
technology needs for the new and existing products
r Opening lines of communication between all R&D, formulation and manufacturing
partners
r Avoiding costly delays through continuous transfer of knowledge and technology
r Developing strategies for tech transfer from lab to pilot and from pilot to commercial
production
r Defining and measuring success throughout the process
Laman Alani, Ph.D.
VP, Pharmaceutical Products and Technology Development
Alcon Laboratories
Breaking into Biosimilars - What does it Mean to be a Global Player in Biosimilars?
r What clinical phases can be skipped when manufacturing a generic of an approved
product?
r Teva's journey in creating and filing BLA's for Neutroval and Balugrastim
r Leading developments of Teva's pipeline - BioSimilars and BioBetters
r Addressing the challenges of achieving bioequivalence
r Looking to Europe for an abridged knowledge of bringing biosimilars to market
r Demystifying the regulatory pathway for biosimilars
David Shen, Ph.D.
VP, Global Head of Biologics Development; Head, Teva-Lonza Joint Steering Committee
Teva Pharmaceuticals
INTERACTIVE WORKSHOP
Intelligent Deployment of High Resolution Analytics and Informatics to Improve
Pharmaceutical Development and QC Processes
r Deploying high resolution analytical tools in late-stage development and QC
r Simplifying data acquisition, automating data processing and managing information
r Generating customized reports without the use of external software to format and
communicating results
r Simplifying and reducing costs for analytical lab compliance
Robert F. Burgoyne
Director, Americas Field Marketing
Waters Corporation
INTERACTIVE WORKSHOP
Patient-Centric Drug Formulation Principles - Balancing Formulation Requirements and
Patients' Treatment Needs
Providing an overview of challenges experienced during formulation
Developing patient-centric oral drug therapies using versatile drug delivery technologies
Successfully navigating drug development pathways
Case studies - taste-masking, orally disintegrating tables and formulation techniques to
preserve efficacy
Ensuring acceptance among niche patient populations
Anthony Recupero
Senor Director, Licensing
Aptalis Pharmaceutical Technologies
Michael Gosselin
Manager, Formulations
Aptalis Pharmaceutical Technologies
MORNING REFRESHMENTS AND NETWORKING
SMALL MOLECULE AND BIOLOGICS - ADVANCES IN DRUG DELIVERY
DEVICES
Panel Discussion: Expanding Developments in Drug-Eluting Devices and Ocular
Pharmaceuticals
r Investigating the opportunities and challenges in developing drug-eluting devices
r Capitalizing on the latest treatment advances in age-related macular degeneration and
diabetic macular edema
r Analyzing drug-eluting devices to treat and monitor diabetes
r Identifying common bottlenecks and interdisciplinary challenges
r What will ophthalmic drug delivery look like in the future?
Andrew Luk, Ph.D.
Senior Director, New Technologies, R&D
CooperVision
Chris Rhodes, Ph.D.
Former Chief Technology Officer
SKS Ocular
George Baklayan
Director, Pharmaceutical Development
Bausch + Lomb
BIOLOGICS - INNOVATION IN PEPTIDE AND PROTEIN THERAPEUTICS
Developing an Injectable Formulation for a Poorly Water Soluble Molecule
r Assessing the potential opportunity lost with poorly soluble molecules
r Case study - Preclinical through clinical investigation of a Roche oncology compound
r Examining platforms and examples for handling poorly soluble compounds
r Achieving the target product profile for such molecules and risk assessment
Farooq Qureshi, Ph.D.
Research Leader & Senior Principal Scientist, Global Formulation Research
Roche
09:20-09:55
09:55-10:55
10:55-11:30

7. Laman Alani, Ph.D.
VP, Pharmaceutical Products and Technology Development
Alcon Laboratories
Thierry Nivaggioli, Ph.D.
Director, Drug Delivery Product Technology
Genentech
INTERACTIVE WORKSHOP
NLAB Silica - Not for any Poorly Solubles but for the Rocks and Brick Dusts
How does NLAB Silica differ from other technologies like lipids, polymers and
nanomilling?
Mechanism behind increased solubility: lock in of the drug in an amorphous state, even
API spread out and molecular dissolution from nano-sized pores
Showcase dramatically increased solubility and sustained release
Uncovering which APIs are suitable for the technology
Next generation applications of mesoporous silica carriers
Andreas Bhagwani
Nanologica
CEO
INTERACTIVE WORKSHOP
Solubility Enhancement Platforms - Bridging API Synthesis and Formulation
Development
r Enhancing API solubility through particle engineering technologies
r Amorphous solid dispersions: screening to select the best performing and stable
formulation and process scale-up
r Nanoparticles technology: combination of particle design technologies for advanced
formulations
r Streamlining tablet formulation development and manufacturing capabilities
r Applying QbD in solid dispersion and nanoparticles process development
Eunice Costa, Ph.D.
Scientist, Drug Product Development
Hovione
SMALL MOLECULE - ENHANCING DRUG BIOAVAILABILITY AND
SOLUBILITY
Challenges and Opportunities in Developing Intravenous Crystalline Nanotechnology
r Approaches for formulating crystalline nanosuspensions
r Overcoming issues of poor solubility and erratic absorption
r Our story of finding the right particle size and toxicokinetic profile
r Looking internationally for inspiration in breakthrough nanotechnologies
Nicholas Barker, Ph.D.
VP, Pharmaceutical Sciences
Cubist Pharmaceuticals
RX-TO-OTC SWITCH
Creation of Value after Loss of Exclusivity for Rx Drugs
How can Rx-to-OTC switch extend a branded product and create value after Rx loss of
exclusivity?
Examining critical considerations for evaluating the switch of Rx compounds to OTC
Understanding how drug delivery technology, route of administration and formulation
enables "switchability"
Extending the lifecycle of molecules for the creation of value to consumers
Joseph Reo, Ph.D.
Head, Lifecycle Management, Rx-to-OTC Switch Center of Excellence
Merck Consumer Care
THEMED LUNCH
What Makes Formulation-Minded
People Turn to Powder in a
Capsule?
Timothy Scott
President
Pharmatek
THEMED LUNCH
Bioavailability Enhancement – An
Integrated Approach to Solving
Bioavailability Enhancement from
Formulation to Process
Development to Market
Michael Sarmento
Director, Business Development,
Modified Release Technologies
Catalent Pharma Solutions
Michael Valazza
VP, Business Development
Catalent Pharma Solutions
THEMED LUNCH
Captisol-Enabled® Repurposed
Compounds - Maximizing Safety
and Improving Solubility, Stability,
Bioavailability and Dosing of APIs
Glenn Dourado
Director, Business Development
Ligand Pharmaceuticals
James D. Pipkin, Ph.D.
Senior Director, New Product
Development
Captisol
THEMED LUNCH
Size and Shape Analysis for
Formulators: How Can we Gain a
Greater Understanding of our
Particles?
Jon Mole
EVP
Sirius Analytical
THEMED LUNCH
Can Automated Technologies be
used to Accelerate DOE Studies
for Drug Substance and Drug
Product Development?
David Yamane
Product Marketing Director, Life
Science
Freeslate
INTERACTIVE WORKSHOP
Experimental Methods for Investigating Supersaturation, Dissolution and Precipitation Behavior of Poorly Soluble Drugs
Increasing bioavailability of drugs for GI absorption through the use of supersaturation
Using solid dispersions to enhance solubility and supersaturation
Evaluating the performance of solid dispersions through the use of dissolution assays
Utilizing Surface Dissolution Imaging and real-time particle size and shape measurement to enhance mechanistic understanding of solubility and dissolution
11:30-12:05
12:05-12:40
12:40-14:00
14:00-14:35

8. Jon Mole
EVP
Sirius Analytical
SMALL MOLECULE - INNOVATION IN SPRAY DRIED DISPERSIONS
Case Study: Expediting Inhalation Product Development by a Novel Cosuspension
Formulation Platform
r Examining spray-dried, low-density particles to deliver microcrystals by using standard
metered dose inhalers
r Focusing on the nature of fine particles and the barriers they create in respiratory
product development
r Using nature instead of fighting it - handling instability of fine particles
r Overcoming regulatory challenges without the need for a novel device
r Simplifying clinical development and removing CMC from the critical path
Sarvajna Dwivedi, Ph.D.
EVP, R&D and Co-Founder
Pearl Therapeutics
SMALL MOLECULE - IMPROVING POORLY SOLUBLE CANDIDATES
Overcoming the Development Trap - Examining Poor Solubility and Bioavailability of
NCEs
Exploring the benefits of bimodal mesoporous silica for poorly-soluble drugs
Examining new developments in inorganic carriers as a safe and effective option
Enhancing solubility with state of the art technologies
Dieter Lubda, Ph.D.
Head, R&D Excipients and Formulation
Merck KGaA
PANEL DISCUSSION - FUTURE FORECAST
Moving Forward - How is Drug Delivery and Formulation Evolving?
What will nanotechnologies, patch infusers, cloud networks, and biobetters look like in 2020?
What implications will these advances have in the drug delivery and development arena?
Improving solubility - what advances can we expect in the next 5 years?
How will outsourcing and emerging markets evolve partnerships and the development landscape?
Andrea Leone-Bay, Ph.D.
VP, Pharmaceutical R&D
MannKind Pharma
James J. Collins
VP, Packaging & Device Design and Development
Eli Lilly and Company
Jerry Murry, Ph.D.
VP, Small Molecule Process and Product Development
Amgen
William Rowe, Ph.D.
Associate Director, Formulation Development
Vertex Pharmaceuticals
Xiaoping Cao, Ph.D.
Technology and Sourcing Lead, Pharmaceutical Sciences Development Center in China
Pfizer
CHAIR'S CONCLUDING REMARKS AND CLOSE OF SUMMIT
Keith Horspool, Ph.D.
VP, Pharmaceutical Development
Boehringer Ingelheim
PLANT TOUR - PHARMATEK FACILITY
Buses will depart from the foyer at 4:25PM
Join Pharmatek for a tour of its manufacturing plant, a 60,000+ sq. ft., custom built facility with six cGMP manufacturing suites, analytical labs, formulation labs and dedicated space
for Highly-Potent and Cytotoxic (HP/C) compound development and manufacturing. There will be a cocktail and appetizer reception before the tour followed by a hosted dinner.
For more information concerning the facility tour please ask one of the World Trade Group staff members on-site or speak directly to a Pharmatek representative.
Kevin Rosenthal
Director, Manufacturing
14:35-15:10
15:10-15:55
15:55-16:00
16:00-19:00

9. Pharmatek

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April 30th-May 1st, 2013
VENUE DETAILS
Manchester Grand Hyatt
One Market Place, San Diego, California, 92101
Tel: (619) 232 1234
Web: www.manchestergrand.hyatt.com
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