Newsletter | October 10, 2019

10.10.19 -- Innovative Learning Events And Opportunities

Conferences And Workshops


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


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


Master Protocol Workshop
October 29 and 30 | Bethesda, MD
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, and operationalization.


Combination Products Conference
October 29 and 30 | 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.


Canadian Pharmacovigilance And Risk Management Conference
November 4 | Gatineau, QC, Canada
Get the latest updates in pharmacovigilance, risk management, and drug safety from both a global and a tailored Canadian perspective.


DIA Annual Canadian Meeting
November 5 and 6 | Gatineau, QC, Canada
Hear directly from Health Canada representatives on recent policy updates and priorities, international work sharing opportunities, and key regulatory and clinical considerations for drugs and devices in Canada and across the globe.


Real World Evidence Conference
November 14 and 15 | Cambridge, MA
How is real world evidence (RWE) being used today to inform biopharmaceutical and medical device development? Join key stakeholders and experienced professionals from regulatory agencies, industry, and academia to discuss the use and importance of RWE throughout the product life cycle.


Pharmacovigilance And Risk Management Strategies Conference
January 27 to 29 | Washington, DC
Get access to the strongest possible context, background, updates, and future direction for the pharmacovigilance industry. Additionally, you'll get answers to all your burning questions and make connections with fellow peers and regulators.


Learning Opportunities


Clinical Statistics For Nonstatisticians
October 14 and 15 | Philadelphia, PA
Get answers to your burning questions and address topics such as confidence intervals, hypothesis testing, trial designs, and methods for establishing noninferiority and equivalence at our premier training course. This course will increase the level of statistical knowledge of nonstatisticians so collaborative efforts of statisticians and nonstatisticians on clinical investigative teams can be improved.


Drug Safety And Pharmacovigilance Across The Product Life Cycle
October 14 to 16 | Philadelphia, PA
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
October 14 to 17 | Philadelphia, PA
Learn about FDA regulations and expectations for the content, submission, and review of INDs and NDAs, and the importance of regulatory strategy.


Benefit-Risk Assessment And Management Across The Life Cycle
October 17 and 18 | Philadelphia, PA
Learn about the principles, legal, and regulatory basis for benefit-risk obligations and frameworks for compliance and discuss the fundamentals of benefit-risk assessment, including methods commonly used and incorporation of the patient perspective.


Advanced Signal Management: Detection, Evaluation, And Decision Making
October 21 and 22 | Washington, DC
Learn to integrate data visualization and data mining within an overall system of product safety risk management and discuss how regulatory authorities expect product safety data to be monitored from clinical development to post-marketing.


Regulatory Affairs For Combination Products
October 28 and 29 | Washington, DC
Address the FDA’s expectation for post-marketing activities, including safety reporting and manufacturing modifications.


Safety Risk Management Communication For Medical Products
November 4 and 5 | Washington, DC
Gain 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.