Regulatory requirements with regard to extractables and leachables.

2017, the next five years, and beyond.

This webinar will provide an overview of a recent research project.

Learn the primary mechanisms of aerosol generation used in nebulization, namely, air jet, ultrasonic, and vibrating mesh nebulization.

A panel of industry, regulator, and academic experts to discuss lessons learned from the previous cases and steps to consider when developing QSP models.

The 5th live event in the Personalized Medicine series.

Siscuss and debate such aspects from industrial and regulatory perspective and would help to exchange of ideas to move the field further.

The 4th live event in the Personalized Medicine series.

A global perspective and discussion on basic GMP audits.

The 3rd live event in the Personalized Medicine series.

Why can’t I have drug disposition just like Mom and Dad? Understanding the impact of transporter and enzyme ontogeny in pediatrics.

The 2nd live event in the Personalized Medicine series.

How microsampling is being used to in the quantitation of drugs, metabolites, and biomarkers in preclinical and clinical development.

Monitoring manufacturing and laboratory processes under continued process verification.

The 1st live event in the Personalized Medicine series.

Introduce formulation scientists, device engineers, and other pharmaceutical professionals to the core technical considerations of respiratory drug delivery.

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

A fresh perspective on networking for introverts and extroverts alike. Get the most out of your networking opportunities!

A discussion among leading experts who have successfully applied these advanced novel analytical technologies in pharmaceutical impurities analysis.

Prepare yourself to participate in the public arena where science is often met with skepticism.

What does one do when spray-drying and melt-extrusion fail to meet the drug product needs for their compound? Join us!

Get the basics here and then a deeper, hands-on experience at the 2017 Annual Meeting!

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

Address the current gap in the field of impact assessment of clinically relevant immunogenicity as it relates to impact on safety.

An exploratory assessment of the topic.

Learn how to focus on the needs of a live audience, not an imagined reader, when preparing and delivering a scientific presentation.

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

Discuss current issues related to the use of surfactants in parenteral formulations.

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

Understand and discuss protein formulation and analytical development.

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.

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.