Newsletter | July 11, 2019

07.11.19 -- Innovative Learning Events And Opportunities

Learning Opportunities


Drug Safety And Pharmacovigilance Across The Product Life Cycle
August 12 to 14 | Boston, MA
Explore contemporary principles, regulatory expectations, and practical approaches to drug safety and pharmacovigilance in key regulatory jurisdictions, with a focus on the U.S. and EU.


Regulatory Affairs: The IND, NDA, And Post-Marketing
August 12 to 15 | Boston, MA
Learn about FDA regulations and expectations for the content, submission, and review of INDs and NDAs, as well as the importance of regulatory strategy.


Navigating Chemistry, Manufacturing, And Controls Through The Drug Development Process
August 12 and 13 | Boston, MA
This course will allow you to apply several of the principals learned to real-life situations and to arm yourself with the tools to write and/or assemble chemistry, manufacturing, and controls (CMC) sections of regulatory submissions, prepare for and orchestrate CMC meetings with the FDA, and provide a clear understanding on how to avoid noncompliance.


New Drug Product Development And Life Cycle Management
August 12 and 13 | Boston, MA
Discuss the phases, major workstreams, key players, and interrelationships necessary to develop new drugs in the U.S. and Europe and to expand the life cycle of inline products.


The Pharmacovigilance Quality Management System
August 15 and 16 | Boston, MA
Learn contemporary principles, practical approaches, and regulatory expectations for the Pharmacovigilance Quality Management System.


Global Clinical Trial Disclosure And Data Transparency Conference
September 19 and 20 | Bethesda, MD
Explore the latest global requirements in clinical trial disclosure and data transparency, share best practices, and engage in in-depth discussions on hot topics.


Biosimilars Conference
September 23 and 24 | Bethesda, MD
Just announced! The keynote speaker at DIA's Biosimilars Conference will be Janet Woodcock, MD, director, Center for Drug Evaluation and Research, FDA. We are very excited to have Dr. Woodcock join us to discuss the biosimilars approval pathway – as well as the challenges faced and educational needs that are to be addressed in bringing safe and effective treatment options to market.


Benefit-Risk Assessment And Management Across The Life Cycle
October 17 and 18 | Philadelphia, PA
Examine the principle, legal, and regulatory basis for benefit-risk obligations and frameworks for compliance. Fundamentals of benefit-risk assessment will be covered, including methods commonly used and incorporation of the patient perspective.


Safety Risk Management: A Focus On EU RMPs And US REMS
October 21 and 22 | Washington, DC
This training course is focused on the strategic and operational aspects of global safety risk management. Key concepts, principles, and tools necessary to develop risk management programs will be introduced.


Safety Risk Communication For Medical Products
October 23 and 24 | Washington, DC
This course provides an introduction to the science of risk communication for medicinal products, the relevant regulatory context in the U.S. and EU, the basics of risk communication in product risk management, and new directions in the field, including the use of digital and other eHealth methods and patient-centered approaches to risk communication.


Pediatric Drug Development Workshop
October 28 and 29 | Bethesda, MD
The DIA Pediatric Drug Development Workshop will bring together the pediatric research community (drug developers, regulators, and academic researchers) to evaluate and discuss how such solutions can be applied to advance the development of biopharmaceutical therapies for pediatric patients.


Oligonucleotide-Based Therapeutics Conference
October 28 to 30 | North Bethesda, MD
The DIA Oligonucleotide-Based Therapeutics Conference fosters open discussion with industry and health authorities to inform, educate, and share advancements in oligonucleotide-based therapeutic product development.


Combination Products Conference
October 28 to 30 | North Bethesda, MD
In an interactive format, relevant stakeholders from regulatory agencies and industry will present the challenges and opportunities in combination product development and life cycle management.


Master Protocol Workshop
October 29 and 30 | Bethesda, MD
DIA’s Master Protocol Workshop will examine the common features and the advantages and limitations of different types of MAPs, along with lessons learned from recent master protocol clinical trials such as LUNG-MAP, I-SPY 2, EPAD, DIAN-TU, and others. Experts will discuss best practices for master protocol study design, collaboration (including navigating public-private partnerships and international considerations), and operationalization.


Measuring Impact In Patient-Centered Drug Development
November 5 and 6 | Silver Spring, MD
Measuring the impact of your patient engagement efforts is key to ensuring that both sponsor and patient derive value from the relationship. Address how to develop and implement measures of success in reaching the goals and overall impact of patient-centered approaches at DIA's Measuring Impact in Patient-Centered Drug Development Conference.