The focus of this event will be to share in more detail specifics of each ICH Q&A and an update on the status of the guideline.

Understand and discuss protein formulation and analytical development.

Experts discuss these draft guidelines and highlight their similarities, differences, and major issues.

Current methods and state-of-the-art approaches.

An exploratory assessment of the topic.

The first GCP presentation of two in this series that will focus on the elements of GCPs in the clinical setting.

Explore the regulatory path-way for the approval of combination products and the unique challenges.

Real-life challenging examples and how GCP is put into action.

Progress drug discovery candidates from any pharmaceutical organization to development with low risk that provide a balance of speed and quality.

Examine the structure and content of core GCP documents, the Investigator’s Brochure, Informed Consent Form, and Clinical Study Reports.

A comprehensive look at ICH Q10 and how it is applied by manufacturing facilities.

How to conduct a sound quality investigation, covering the basics of root cause assessments, corrective and preventative actions.

A global perspective and discussion on basic GMP audits.

Focus on formulation, formulation analysis, and bioanalytical components of GLP compliance.

Review the state-of-the art nature of this field; pros and cons of different approaches and how these systems will have consequences.

Highlight the three winning research articles from the PPB Student Committee implemented a Best Student/Postdoc Manuscript Contest.

Can you See what I See? As modeling becomes more and more powerful and should be seen as the future for oral drug development.

Discuss the new FDA guidance and interact with scientists to discuss the consequences to industry.

The do’s and don’t’s from effective job search to durable career development.

Everything you need to know about Japan's new drug application-specific bracketing strategies.

Understand the principles and applications of primary 3D micro-imaging technology.

Come discuss six LBA methods validated either in house or at a CRO to support bioanalysis for GLP toxicokinetic or clinical pharmacokinetic studies.

Hear the arguments for each side of this debate and decide who wins your vote!

Exploring the pre-clinical and translational development of therapeutic antibodies.

How to Utilize Current Technology in Designing Successful Characterization and Control Strategies.

New methodologies in intrinsic clearance measurement, reaction phenotyping, and metabolite identification for low clearance compounds.

Monitor particulate matter in parenteral drug products.

A discussion on emerging trends in antibacterial drug research.

Demise of the heavy metals approach and implementation of ICH Q3D and USP <232> and <233>: considerations and challenges.

Transporter changes in the setting of liver disease can lead to clinically significant changes in drug disposition.

Faster and better evaluation and prediction of formulation properties and the improvement of biopharmaceutical development.

Discuss the challenges encountered with multiplex LBAs, the underlying causes, and explore tangible solutions.

How to design and execute manipulation and extraction studies.

Recommendations from the AAPS Biosimilars Committee and reflections on regulatory feedback.

A discussion of the recent FDA guidance with a focus on safety.

Focus on the CMC considerations for the development, manufacture, and characterization of Bi-specific Abs.

Explore statistical evaluation of critical quality attributes (CQAs), which define the purity, potency and safety of a protein therapeutic, for the purpose of...

Paradigm-shifting innovations to assess OATP DDI liabilities.

Regulatory Requirements, Testing Concepts and a Holistic Approach to Designing a High-Quality Container Closure System.

Disscuss recent innovative applications of LC/MS for ADA measurement in drug discovery and development and case studies to provide some insight of this new technology.

Preformulation considerations for development of extemporaneous on-site compounded (OSC) drug in bottle (DIB) formulations.

Drug Application Webinar Series: Type II Drug Master Files – API Submissions

Join us and learn the art of selling your science!

A hands on experience with the BioRAM tool and Q&A with the experts.