Utilization of Clinical Pharmacology Data to Support a Demonstration of Biosimilarity
Utilization of Clinical Pharmacology Data to Support a Demonstration of Biosimilarity by Partha Roy, Ph.D.�
Home
»
Slideshare - All Slideshows
»
Utilization of Clinical Pharmacology Data to Support a Demonstration of Biosimilarity
Most Recent Presentations
Improving Processes for Temperature Traceability from Packaging to Patient
Check out this presentation from PAREXEL Randomization and Trial Supply Experts to learn about temperature monitoring practices throughout the clinical trial supply chain, including: traditional tempe
Life of a Biosimilar
Check out this presentation from PAREXEL Consulting experts to learn about key regulatory processes affecting biosimilars development including an an overview of the 351(k) Pathway, FDA approvals and
Effective Strategies for Successful Global Development
Learn how to leverage effective strategies for global drug development, including expedited regulatory pathways, personalized medicines and genomics. View the full presentation from PAREXEL Consulting
Trends in Early Development
PAREXEL Early Phase Clinical Research Services experts discuss developing trends in drug development including adaptive trials design, real-world data and biomarkers.
Understanding Regulatory and Payer Requirements Throughout Commercialization
Learn about regulator and payer evidence requirements as well as other key market access considerations in drug development. Read this presentation from PAREXEL Consulting experts.
Innovative Pricing and Reimbursement Schemes - The Why, What, Which & How
Learn about the need for innovation in global reimbursement mechanisms, the potential risks and benefits of implementation, and real world examples in a presentation by PAREXEL Access Consulting Exper
Leveraging Imaging and Wearable Technology For Agile Clinical Trials
Learn how to manage and overcome key challenges to deploying imaging and wearable technology effectively in clinical trials from PAREXEL Consulting experts.
Effective Regulatory Strategies for China Market Entry
Learn about the impact of China 's regulatory reforms for companies conducting clinical research in the country from PAREXEL Consulting experts.
Seamless Dataflow with a Clinical Metadata Repository
Learn how PAREXEL's Clinical Metadata Repository can help improve the way you manage clinical trial data.
FDA Initiatives Under The 21st Century Cures Act
Learn about FDA's priorities for implementing The 21st Century Cures Act and how they will impact clinical research from PAREXEL Consulting experts.
Exploring Ways to Enhance Evidence Generation & Communication Planning
PAREXEL experts explore key aspects of successful evidence generation and communication plans and how to apply them in your organization.
Operational Aspects of Independent Reviews for Immune-Oncology Clinical Endpoints
PAREXEL Consulting experts detail operational aspects of independent reviews in the context of immunotherapy clinical trials.
Development Considerations Comparing Major Markets Including US, EU, Japan and China
PAREXEL Consulting experts compare regulatory requirements in major drug development markets including the US, EU, Japan and China.
Understanding Different Stakeholder Requirements Throughout Commercialization
Learn how to use Real World Evidence (RWE) to bridge the evidence gap between regulators and payers.
The Art and Science of Productive FDA Meetings
View the presentation to learn key strategies for optimizing meetings with the FDA.
Generating Evidence to Drive Patient Access
View this presentation to learn strategies for generating evidence that will help your product clear market access hurdles.
Regulatory Strategy In Emerging Markets
PAREXEL Principal Consultant Angela McGillivary discusses commercial considerations, clinical development, regulatory requirements, submission and post approval strategies in emerging markets
Aligning on Patient Outcomes - How Market Dynamics Can Facilitate RWD Solutions