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ADAPTIVE CLINICAL DESIGNS/ADAPTIVE METHODS
Adaptive Design in Clinical Research
Radical Change in Clinical Development
Selecting the Optimal Sample Size: Initial Realism or Adaptive Re-estimation
Are You Ready for Adaptive Clinical Development? Part 1 of 2
Are You Ready for Adaptive Clinical Development? Part 2 of 2
Recent Advances in Adaptive Clinical Trial Designs
Solving Complex Problems in Clinical Trial Supply Management
Novel Statistical Issues from the Regulatory Biostatistician’s Viewpoint
Future Advancements in Models and Algorithms for the Optimization of Clinical Trial Recruitment
Integrating Market Perspectives into R&D Strategy
APPROVAL PATHWAYS FOR PRODUCTS TO TREAT RARE DISEASES
Biomarkers in Drug Development: What a Project Manager Needs
to Know and Do to Enhance Project Value
Global Oncology Product Development: Strategies for Successful
Selection of Patient Populations and Study Endpoints in Early
Phase Clinical Development
Arsenic and Old Lace II: Newer Aspects of QT Study Design,
Sample Size, FDA Feedback, and Oncology Considerations
Clinical Trial Data and Coding Processes
Harmonization of Requirements for the Preclinical Development of
Anticancer Drugs
Targeted Disease Approach Using Natural Health Products
Integrating Clinical Research with Clinical Care
BIOTECHNOLOGY
Facilitating the Regulatory Approval of Products for Public Health
Emergencies: Emerging Infectious Diseases or Intentional Terrorist
Acts
Recent Advancement of Novel Biotechnology in the Asian Pacific Region
Hot Topics in Biotechnology
Gene Therapy Regulations for EU Clinical Trials
RNA Therapeutics: Bringing the Future of Biological and Medical
Innovation to Today
Current Experiences in Stem Cell Therapies
Biosimilars/Follow-on Biologics
Biotechnology-derived Products and the Immune System:
Management of the Effects of the Interaction(s)
Nanotechnology Task Force: Regulating Nanotechnology Products
Adding Value to Resource-constrained, Early-stage Biotechnology
Product Development from the Regulatory Perspective
Using Systems Biology to Advance Knowledge-based Drug
Development
Understanding the Regulation of Advanced Therapy Medicinal
Products in Europe
Biotechnology Venture Roundtable
An Honest Look at the eClinical Process: How Biotechnology Can
Learn from Best Practices Outside the Industry
Industry Insights: Forging Partnerships with NIH-sponsored Clinical
Trials and Networks
Becoming a Sponsor of Choice for Clinical Investigators
Issues and Case Studies in Safety Data Migration
How Much Information Technology Do Early Stage Biotechnology Firms Need?
Outsourcing Strategies and Trial Management in Asia
The State of Clinical Outsourcing: Results from a 2008 Industry
Survey with a Focus on Transforming Business Relationships
between Sponsors and CROs
Developing a Balanced Matrix and Maturing Product Development Teams
Identification of Opportunities between CRO and Pharma for
Synergistic Application of Lean Six Sigma
Enterprise Project Management in Pharmaceutical R&D: The Journey Continues
The Evolving Role of Project and Alliance Managers at Each Stage
of Product Development
Establishment of a Regulatory Function in a Startup
Biotechnology/Pharmaceutical Company
EU Variation Regulations Update
Review of ICH Q5AQ5E Guidances and Experiences
CBER Safety Initiatives's (Blood, Tissue, Vaccines)
Changing Procedures for Conducting Clinical Trials in Europe
New Strategies for Successful Licensing Acquisitions
Biotechnology R&D in Developing Countries: A Public-private
Partnership between the Ludwig Institute, a Brazilian
Entrepreneurship, and Health Institutes
CLINICAL AND REGULATORY CONSIDERATIONS FOR
PERSONALIZED MEDICINES
Drug Diagnostic Co-development: Implications for Biomarker
Validation and Personalized Medicine
Personalized Medicine and Its Impact on Drug Development and
Commercialization
Personalized Medicine: 2008 Update
Accelerating Research: Integrating Clinical Research with Clinical
Care
Emerging Clinical Documents for Medical Writers
COMBINATION DEVICE AND THERAPEUTIC PRODUCTS
Modernization of FDA Postmarket Adverse Event Information Management
FDA Draft Guidance: Protecting the Rights, Safety, and Welfare of
Study Subjects
Issues and Case Studies in Safety Data Migration
Recent Advancement of Co-development of Medical Devices and
Drugs in the Asia-Pacific Region
Dealing with Potential Geno-toxic Impurities (GTIs) Especially in
FDC (Fixed Dose Combination) Drug Products for Global Clinical
Trials
RAHP Gold: Device Track Masters
CRITICAL PATH INITIATIVE
The Impact of FDAAA and Health Information Technology
Interoperability Activities on Drug Safety, Implementation of
Standards, and Data Stewardship Principles
The Intersection of CDISC Standards with Research Site Processes
Facilitating the Regulatory Approval of Products for Public Health
Emergencies: Emerging Infectious Diseases or Intentional Terrorist
Acts
Recent Advancement of Novel Biotechnology in the Asian Pacific Region
Hot Topics in Biotechnology
Nanotechnology Task Force: Regulating Nanotechnology Products
Imaging Biomarker Data Management
Tools for Integration of Biomarkers
Drug-induced Liver Injury (DILI): How Well Do Preclinical and
Clinical Studies Predict Hepatotoxicity?
Improving the Quality and Implementation of Medical Imaging in
Clinical Trials: Industry/Academia/Government Consortia
Current Challenges and Future Solutions in the Development of
Therapeutic Options for Patients with Community acquired
Pneumonia (CAP): Clinical and Regulatory Perspectives
Standards Shock Therapy: Demystifying the Current and Future
Roles of CDISC and HL7 Standards for Clinical Research and
Regulatory Submissions
FDA and CDISC eSubmission Pilots
How Much Information Technology Do Early Stage Biotechnology Firms Need?
Consortium Efforts in Safety Biomarker Discovery and Qualification
Biomarkers in Drug Development: What a Project Manager Needs
to Know and Do to Enhance Project Value
Women’s Health under the FDA Critical Path Initiative
Facilitating Global Pediatric Drug Development: An Assessment of
Recent Experience
Critical Path Update for 2008
US-EU Agreement: Administrative Regulatory Simplification, the Next Phase?
Innovative Medicines and the EMEA
One-year Experience after FDA Guidance on the Target Product
Profile
Genomic (Surrogate) Biomarker in Therapeutic Trials
MULTINATIONAL CLINICAL TRIALS INCLUDING DEVELOPING COUNTIRES
Effective Working with Investigative Sites: Essentials for Clinical
Trial Conduct in the Emerging World
Conducting Clinical Trials in China
Leveraging Technology to Build an IT Infrastructure for Global Clinical Trials
Emerging Clinical Documents for Medical Writers
Outsourcing Strategies and Trial Management in Asia
Outsourcing to India and China: Managing R&D Projects
The Next Generation of Project Managers: PMs as CEOs
Doing the Project Planning for Large Multinational Clinical Trials
Regulatory Strategies in Latin America: New Conquest for
Pharmaceutical Companies for Timely Submissions and Project
Startups in Mexico and Other Latin American Countries
Regulatory Requirements for Conducting Clinical Trials in India,
China, and Russia
Dealing with Potential Geno-toxic Impurities (GTIs) Especially in
FDC (Fixed Dose Combination) Drug Products for Global Clinical
Trials
Public-private Partnership on Clinical Research in the Asia-Pacific Region
Multiregional Clinical Trials: Evaluating the Pros and Cons
PATIENT RECRUITMENT AND RETENTION
Accelerating Research: Integrating Clinical Research with Clinical Care
Proof-of-concept Clinical Trials and Achieving Enrollment Goals
through Centralized Recruitment Tools
Restructuring Protocol Design to Fit the Needs of the Research Subject
Global Patient Recruitment and Retention: Identifying and
Overcoming Barriers to Accelerate Patient Recruitment and
Retention Worldwide
The Third Annual Session on Investigator Budgets and
Reimbursement: The Impact on Patient Enrollment and Retention
The Six Risk Areas of Clinical Trial Patient Enrollment
Subject Recruitment in the US: Is It a Losing Proposition?
The Keys to Establishing Best Practices for Accelerated Study Startup
Patient Recruitment Strategies and Sites’ Perspectives
Data-driven Patient Recruitment: Tools for Early Planning and
Predictive Management
Global Oncology Product Development: Strategies for Successful
Selection of Patient Populations and Study Endpoints in Early
Phase Clinical Development
Site Relationship Management (SRM) Initiatives for Improving Site Performance
Going “Glocal”: The Trend in Global Patient Recruitment and Retention
Thirty Ways to Increase Enrollment at Your Site
Addressing the Adverse Impact of Increasing Protocol Complexity
on Study Conduct Performance
Patient Enrollment: Underrepresented Populations
Becoming a Sponsor of Choice for Clinical Investigators
Understanding Clinical Trial Volunteer Experiences and Physician
Referrals to Clinical Trials
Accelerated Recruitment Strategies for Global Megastudies
Electronic Data Capture as a Strategy to Enhance Complete Data
Capture, Site Satisfaction, and Participation in Registries and
Observational Studies
Meeting Clinical Research Challenges in India
Outsourcing to India and China: Managing R&D Projects
PEDIATRICS
Facilitating Global Pediatric Drug Development: An Assessment of
Recent Experience
Emerging Clinical Documents for Medical Writers
Pediatric Drug Development
Incentives and Rewards for Innovation in Pharmaceutical Development
BPCA Reauthorized: What's Next?
Innovative Approval Paths Are Needed for Products that Treat Rare Diseases
Innovative Medicines and the EMEA
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