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Trk 08: Reg Affairs [clear filter]
Sunday, June 26
 

8:30am

#22: Successful Drug Development: Best Practices for Clinical Trial Design, Agency Interactions, and Regulatory Document Writing
Component Type: Tutorial
CE: ACPE 3.25 Knowledge UAN: 0286-0000-16-508-L04-P; CME 3.25; IACET 3.25; RN 3.25

An additional registration fee is required for all preconference tutorials. Register today for this tutorial.

Understanding best practices is critical as you design a clinical program and regulatory strategy for a drug or biologic product. Identifying and obtaining the data actually needed for a product development program is key to the success of the program. Thinking ahead to the marketing application helps a sponsor avoid many of the common mistakes that are made in designing individual clinical trials and overall drug development programs. Even though it may be years before an NDA/BLA/MAA submission, the marketing application is the goal of each development program and should be kept in view throughout the program to avoid pitfalls and delays in submission and product approval.

This tutorial will cover common mistakes and solutions in the areas of drug development planning, clinical study design, statistical analysis planning, regulatory agency interactions, and regulatory document writing. Practical advice for each of these areas will be presented, with an emphasis on learning from past examples and case studies that illustrate approaches to adopt or to avoid.

Who should attend?

This tutorial is designed for professionals with basic knowledge in regulatory affairs, agency submissions, and regulatory medical writing.

Learning Objectives

• Identify ways to increase the efficiency and success of product development programs;
• Describe key principles for successful regulatory interactions during drug development and marketing application preparation;
• Discuss best practices in developing successful clinical trial designs, statistical analysis plans, and regulatory submission documents.


Speakers
avatar for Elaine Taylor

Elaine Taylor

Executive Director, Regulatory Consulting and Submissions, INC Research
Elaine B. Taylor is Global Head of Regulatory Consulting and Submissions at INC Research responsible for leading a global team of regulatory professionals providing consultation, development, and management of regulatory interactions and submissions for sponsors. With over 25 years... Read More →
avatar for Kathryn Wekselman

Kathryn Wekselman

Senior Director, Regulatory and Scientific Affairs, CTI Clinical Trial and Consulting Services
Kathryn Wekselman is Senior Director of Scientific and Regulatory Affairs at CTI Clinical Trial and Consulting Services in Cincinnati, OH. Before joining CTI in 2012, she worked for 5 years at CROs as a Director and Senior Director of regulatory consulting and submissions for pharmaceutical... Read More →


Sunday June 26, 2016 8:30am - 12:00pm
102AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

8:30am

#24: Regulatory Considerations for Drug and Medical Device Development: Current Status and Trend of IND/NDA Practices in China
Limited Capacity seats available

Component Type: Tutorial
CE: ACPE 3.25 Knowledge UAN: 0286-0000-16-509-L04-P; CME 3.25; IACET 3.25; RN 3.25

An additional registration fee is required for all preconference tutorials Register today for this tutorial.

The Chinese regulatory landscape seems unique from and harmonious with global standards and practice. In 2015, Chinese good clinical practice (GCP) guidelines published by the China Food and Drug Administration (CFDA) have been amended significantly, of which some GCPs are overturning common ways that were implemented since 2003. The CFDA is enhancing inspective forces on the quality and integrity of clinical trial outcomes. GCP requirements on medical devices and diagnostics have also been strengthened by CFDA. The procedures of investigator new drug/new drug application (IND/NDA) review and approval have been greatly reformed. The quality of trial data is becoming more essential as evidence of supporting NDA approval. All of these updates are sure to impact the IND/NDA drug and medical devices/diagnostic strategies in China. This tutorial will provide insights into critical considerations impacting IND/NDA practices involving drugs and medical devices/diagnostics development in China and upcoming CFDA reformations of regulatory submission review and approval.

Who should attend?

This tutorial is designed for professionals in regulatory affairs, drug development, medical device/diagnostics, clinical trial management, monitoring, data management or clinical operations who have some basic knowledge of the Chinese regulatory environment and will benefit from learning updates of IND/NDA drug and medical device trials.

Learning Objectives

• Describe basic CFDA regulatory requirements for an IND/NDA process;
• Explain Chinese regulatory practice and trends for reviewing and approving submissions of drugs;
• Discuss the updated Chinese GCP guidelines for IND drug trials;
• Explain how to be compliant with Chinese GCP standards in the implementation of clinical trial;
• State how to complete the IND/NDA application process to the CFDA.


Speakers
EH

Earl Hulihan

Professor, SUTCM
Professor Hulihan is Principal with ew hulihan and associates, inc. For over 35+ years, Hulihan has been active in the DIA, in Medicine, as well as providing regulatory consulting, auditing, and training services to the global pharmaceutical community and regulatory authority personnel... Read More →
avatar for Daniel Liu

Daniel Liu

Chief Science Officer, Beijing Clinical Service Center
Daniel Liu, PhD, has served for more than two decades in global clinical research departments, in both management and operations, for such multinational drug companies as Novartis, Pfizer, Sanofi, Schering-Plough, Johnson & Johnson, and Medidata. Dr. Liu has served as Core Expert... Read More →


Sunday June 26, 2016 8:30am - 12:00pm
104AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

1:00pm

#30: Japan Regulatory Environment: Overview of the Organization, Processes, Systems, and Changes Affecting Pharmaceutical Development
Component Type: Tutorial
CE: ACPE 3.25 Knowledge UAN: 0286-0000-16-510-L04-P; CME 3.25; IACET 3.25; RN 3.25

An additional registration fee is required for all preconference tutorials. Register today for this tutorial.

Significant changes in Japanese pharmaceutical regulations and procedures are impacting the development of new drugs in Japan as well as global development programs. This tutorial will describe the major drivers of the regulatory system, including the Pharmaceuticals and Medical Devices Agency (PMDA) and Ministry of Health, Labor and Welfare (MHLW), regulatory procedures during drug development (Consultations with PMDA and Clinical Trial Notifications), the integration of Japanese drug development with East Asian and global drug development, accelerated approval pathways (sakigake; regenerative medicine), orphan drug regulation and J-NDA review. Several development strategies available to address Japanese requirements for new drug approval, as well as selected post-approval requirements, will be discussed.

Who should attend?

This tutorial is designed for professionals involved in regulatory affairs, project management, and clinical development who are involved with global development projects involving Japan.

Learning Objectives

• Explain the major elements of the Japanese regulatory system;
• Describe the regulatory procedures during development, registration, and post-approval;
• Discuss specific attributes of the Japanese regulatory system and their impact on local and global development strategies.


Speakers
avatar for Alberto Grignolo

Alberto Grignolo

Corporate Vice President, Parexel
Alberto Grignolo, PhD is a Corporate Vice President at Parexel, and established the firm's Japan Consulting Services during a two-year assignment in Tokyo. Dr. Grignolo has served as an adviser on human subject protection in clinical trials to the Institute of Medicine of the National... Read More →
avatar for Yoshiaki Uyama

Yoshiaki Uyama

Director, Office of Medical Informatics and Epidemiology, Pharmaceuticals and Medical Devices Agency (PMDA)
Yoshiaki Uyama, PhD, is Director, Office of Medical Informatics and Epidemiology, for the Pharmaceuticals & Medical Devices Agency (PMDA), Japan. His experience in the safety review and assessment of new drugs for PMDA includes serving as the Review Director; as International Conference... Read More →


Sunday June 26, 2016 1:00pm - 4:30pm
102AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

1:00pm

#31: Preparing for a US FDA Advisory Committee Meeting
Limited Capacity seats available

Component Type: Tutorial
CE: ACPE 3.25 Application UAN: 0286-0000-16-511-L04-P; CME 3.25; IACET 3.25; RN 3.25

An additional registration fee is required for all preconference tutorials. Register today for this tutorial.

What are the critical factors when preparing for an FDA Advisory Committee meeting? Appearing before an FDA Advisory Committee can be one of the most challenging and grueling experiences for any drug, device, or biologic team. In just eight short hours with the FDA Advisory Committee, you not only must thoroughly explain but also defend, in detail, your product in a highly visible, high-stakes public meeting. This tutorial teaches best practices for preparing for an FDA Advisory Committee meeting, and it is set up like an actual Advisory Committee meeting.

What You Will Learn:
• What is an advisory committee?
• What does an advisory committee “look like”?
• Critical factors for advisory committee preparation
• How to design the most applicable preparation program for your team
• Top ten “best practices” and “must avoids.”

Who should attend?

This tutorial is designed for professionals in regulatory affairs, clinical research leads, and corporate executives.

Learning Objectives

• Identify the critical factors in preparing for a successful advisory committee meeting;
• Recognize and evaluate those factors that are most applicable to your team;
• Design the most effective preparation for your team(s).


Speakers
avatar for Kaia Agarwal

Kaia Agarwal

Independent Regulatory Consultant, PharmApprove
Kaia Agarwal is an independent strategic regulatory affairs consultant working with PharmApprove. She helps teams prepare and implement global regulatory strategy for their products as they prepare for critical interactions with regulators, including EMA and FDA. For over 27 years... Read More →
avatar for Lisa Peluso

Lisa Peluso

Principal Consultant, Strategic Communications, PharmApprove, a Member of the NDA Group
Lisa helps development teams to align strategically and communicate persuasively with global regulators and payers. She empowers teams to create and deliver clear, consistent, and convincing messages to critical audiences and decision-makers. She has coached hundreds of individuals... Read More →


Sunday June 26, 2016 1:00pm - 4:30pm
103A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

1:00pm

#34: Ethical Issues in Clinical Trials
Limited Capacity seats available

Component Type: Tutorial
CE: ACPE 3.25 Knowledge UAN: 0286-0000-16-512-L04-P; CME 3.25; IACET 3.25; RN 3.25

An additional registration fee is required for all preconference tutorials. Register today for this tutorial.

This tutorial will provide an overview of the various ethical considerations associated with conducting clinical trials, including the history of ethical principles - Nuremburg Conventions, Declaration of Helsinki, The Belmont Report, and ICH. Topics will include obtaining ethics committee and regulatory authority clearance, subject informed consent, investigator conflict-of-interest, issues of fraud, authorship, and ensuring subject safety and well-being. In addition, consideration will be given to conducting studies in emerging economy populations where fair distribution of risks and benefits come into play. It will become evident, through case examples, that these issues are not always black-and-white, and that the situation in which these issues are considered result in many shades of gray.

Who should attend?

This tutorial is designed for pharmaceutical company clinical operations staff, clinical trial site investigators and study coordinators, ethicists, regulators and regulatory affairs staff.

Learning Objectives

• Discuss the foundations of ethics;
• Explain how ethical decisions may be influenced by context and experience;
• Discuss the viewpoint of the clinical study subject when educating clinical study site staff about ethical considerations.


Speakers
avatar for Art Gertel

Art Gertel

President and Principal Consultant, MedSciCom, LLC
Dr. Gertel has more than 40 years of experience in the pharmaceutical industry in virtually all phases of pharmaceutical drug research and development, from preclinical pathology/toxicology to registrational clinical trials, post-marketing trials, project management, and market support... Read More →


Sunday June 26, 2016 1:00pm - 4:30pm
104AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA