How does the Japanese regulatory system impact on local and global drug development strategies?

Japan's Regulatory Environment: Overview of the Organization, Processes, Systems and Changes Affecting Pharmaceutical Development:
June 23 from 8:30AM – 12:00PM in Boston

This tutorial is designed for professionals in regulatory affairs, project management, and clinical development who are involved with global development projects involving Japan. 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 PMDA and Ministry of Health, MHLW, regulatory procedures during drug development, the integration of Japan drug development with East Asian and global drug development, orphan drug regulation and J-NDA preparation and review.

Instructor:
Alberto Grignolo, PhD
Corporate Vice President, Global Strategy and Services
PAREXEL Consulting, United States

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What's the best way to identify and correct dysfunctional group dynamics?

Leadership: How to Organize and Lead People in Group Work - June 23 from 8:30AM – 12:00PM in Boston

This tutorial is designed for individuals who must manage group activities on a permanent or project basis, for those who must work on teams but are not in charge of teams and are interested in learning how to exert influence on group behavior, and for individuals to whom project managers report. The role of a leader in organizing and leading a group is often misunderstood and, as a consequence, the group may not perform up to expectations, or it may spend a considerable amount of time dealing with dysfunctional group dynamics instead of the work to be accomplished. This tutorial addresses those issues by exploring the types of work groups, how they can be more effective, and how individuals can correct group dynamics and help the group achieve higher levels of performance.

Instructor:
Michael Laddin, MBA,MS
CEO
LeaderPoint, United States

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How can clinical trial design impact reimbursement potential?

Global Reimbursement Systems: A Market Access Perspective
June 23 from 8:30AM – 12:00PM in Boston

This tutorial is designed for pharmaceutical industry employees not familiar with market access (pricing, reimbursement, health economics) issues. Reimbursement approvals from payers (reimbursers) have become as important as regulatory approvals for pharmaceutical product success and providing access to patients. Even with reimbursement approval, payer restrictions such as step edits and individual patient approval significantly impact product usage. This tutorial will provide an overview of global reimbursement systems including health technology assessments (eg, NICE), and discuss ways in which evidence of value from clinical trials can help or limit market access.

Instructor:
John Brennick, MPA
Director, Worldwide Market Access
Janssen Global Services, LLC, United States

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What's the best design processes to guide you through the progression of research and development?

Fourteen Steps from Research to Development
June 23 from 1:00PM – 4:30PM in Boston

This tutorial will include discussion of each of the 14 steps used to develop the optimal strategic plan will address the resources and various approaches to tailoring the plan to a sponsor’s specific product under development and obtaining FDA concurrence with the strategic plan. A smooth progression through the preclinical process into early clinical programs will be presented in this half day tutorial targeted to familiarize pivotal staff in startup companies with the required terminology and functions, pharmaceutical/biological companies that have yet to file INDs and those who want to improve their early development approach.

Instructor:
Michael R. Hamrell, PhD,RAC
President
MORIAH Consultants, United States

What’s more…Receive $100 off of your DIA 2013 Annual Meeting registration by registering for two half day tutorials or one full day tutorial. Please note purchases must be made at the same time in order to receive the discount.

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What do you need to know about statistics? Variability~confidence intervals~hypothesis testing~p-values?

Clinical Statistics for Nonstatisticians
June 23 from 9:00AM – 5:00PM in Boston

This tutorial will introduce basic statistical concepts that are fundamental to clinical research. It is designed for individuals with some exposure to statistics (either through course work or on-the-job experience) that is equivalent to an introductory statistics course. While a few formulae are included for individuals who are interested in computational details, the overall emphasis of the tutorial will be on the application of statistical concepts to clinical investigation.

Instructor:
Michael C. Mosier, PhD
Director, Biostatistics
EMB Statistical Solutions, LLC., United States

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What is the appropriate response to FDA enforcement?

FDA Enforcement: Understanding the Agency's Authority, How Violations Occur, How to Prevent Them and How to Respond if Violations Do Occur
June 23 from 8:30AM – 12:00PM in Boston

This tutorial is designed for all personnel responsible for ensuring compliance with FDA requirements, particularly those under the GMP and GCP rules, regardless of whether in a supervisory or direct role. This tutorial will review and discuss the legal, regulatory, and practical challenges of (1) FDA enforcement priorities for 2013 and beyond; (2) FDA administrative enforcement weapons and how the Agency uses them; and (3) the civil and criminal penalties for violations. Interactive discussions will focus on how FDA operates and makes decisions and how to respond effectively, using tactics ranging from negotiation to, when appropriate, litigation.

Instructor:
Michael A. Swit, JD
Special Counsel
Duane Morris, LLP, United States

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Do you know how to recognize the impact of benefit-risk assessment in safety data?

Analysis of Safety Data from Clinical Trials
June 23 from 1:00PM – 4:30PM in Boston


This tutorial is designed for RA professionals, epidemiologists, drug safety professionals, medical affairs professionals, pharmacovigilance and quality management professionals, and clinical affairs professionals. The tutorial is a combination of theory, guidelines, practical considerations and real life solutions for those working in the clinical development environment. The aim of this tutorial is to provide a basic understanding of the underlying methodology and the current guidelines on safety data. Aspects of the planning of clinical trials as well as the problems and pitfalls during the analysis of safety data will be presented. The presentations will also include case studies.

Instructor(s):
Joachim Vollmar, MSc
Executive Consultant
International Clinical Development Consultants LLC, United States

Juergen Kuebler, PhD
Global Head, Clinical Design, Analysis, and Reporting
CSL Behring GmbH, Germany

What’s more…Receive $100 off of your DIA 2013 Annual Meeting registration by registering for two half day tutorials or one full day tutorial. Please note purchases must be made at the same time in order to receive the discount.

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What are the top ten "best practices" and "must avoids" in preparation for FDA Advisory Committee Meeting?

Preparing for a US FDA Advisory Committee Meeting
June 23 from 9:00AM – 3:45PM in Boston


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.

Instructor:
Pete Taft,
President
Taft and Partners, United States

What’s more…Receive $100 off of your DIA 2013 Annual Meeting registration by registering for two half day tutorials or one full day tutorial. Please note purchases must be made at the same time in order to receive the discount.

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Do you know the regulatory pathways for successful clinical trial and marketing applications in China?

Understanding and Navigating the Regulatory System in China
June 23 from 9:00AM – 5:00PM in Boston

This tutorial will provide an overview of the regulatory system in China, including the agencies and institutions at the central government and provincial levels, as well as their roles and responsibilities. Various regulations for product registration, clinical trials, and safety reporting will be presented, and the regulatory pathways and strategic considerations for clinical trial and marketing applications will be discussed. A step-by-step roadmap of how to navigate the regulatory system in China for clinical trial approval and product registration will also be discussed. This discussion will include key points to consider, strategies, and tactics.

Instructor(s):
Laurence Bin Huang, MS
Executive Director, Regulatory Affairs
AstraZeneca Pharmaceutical Co., Ltd., China

Wendy Yan, PharmD
Global Regulatory Strategist
Bayer Healthcare Co. Ltd, China

What’s more…Receive $100 off of your DIA 2013 Annual Meeting registration by registering for two half day tutorials or one full day tutorial. Please note purchases must be made at the same time in order to receive the discount.

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How do you prepare a clinical overview document suitable for multi-region submissions?

Art of Writing a Clinical Overview
June 23 from 9:00AM – 5:00PM in Boston

This tutorial provides an in-depth analysis of the preparation of a clinical overview for pharmaceutical products (drugs and biologics) in accordance with ICH guidelines concerning development of Module 2.5 of a Common Technical Document (CTD).

Instructor:
Patricia A. Matone, PhD
President
Scientific Information Services LLC, United States

What’s more…Receive $100 off of your DIA 2013 Annual Meeting registration by registering for two half day tutorials or one full day tutorial. Please note purchases must be made at the same time in order to receive the discount.

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What are the new international standards and terminologies for reporting to EudraVigilance?

Highlights of the New Pharmacovigilance Legislation in the EU: Key Pointsto be Taken into Account for Successful Implementation and Lessons Learned
June 23 from 1:00PM – 4:30PM in Boston

This tutorial will focus on the impact of the changes in relation to the new reporting rules and requirements as set out in the Commission’s Implementing Measures and the GVP Modules and the big impact on the operational procedures and the day to day activities of stakeholders. It will also highlight the strengthening of the EudraVigilance System to improve transparency, data quality and to support signal detection and management activities in the EU. In addition, specific emphasis will be placed on informing, explaining and helping stakeholders apply the new rules taking into account the international standardization and harmonization activities and data privacy challenges.

Instructor(s):
Sabine Brosch, PharmD,PhD
Business Lead, EudraVigilance and International Standardisation in PhV
European Medicines Agency, European Union, United Kingdom

Barton L. Cobert, MD,FACP
President
BLCMD Associates, LLC, United States

What’s more…Receive $100 off of your DIA 2013 Annual Meeting registration by registering for two half day tutorials or one full day tutorial. Please note purchases must be made at the same time in order to receive the discount.

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DIA2013 offers a custom-fit leadership approach for women in middle-management RA and legal functions.

The DIA - HBA Skill Building Series: A Custom-Fit Leadership Approach for Women in the Regulatory, Medical, Legal and Compliance Functions

This interactive workshop will be held June 23 from 1:00 - 6:00PM in Boston, MA and is designed to improve leadership agility and performance. You will learn how executives in these functions express their value and will work with tools to help them identify and articulate their own unique value to their business partners within the pharmaceutical, biotechnology, and medical device industry. The new insights and leadership skills gained at the workshop will be immediately applicable in the work setting.

Instructors:
Welcome & Opening Remarks
Minnie Baylor-Henry, JD, RPh, DIA President Elect
Worldwide Vice President, Regulatory Affairs
Johnson & Johnson Medical Devices & Diagnostics

Session 1: Industry Trends and Key Criteria for Business Success in Today’s Environment

Session 2: Business Acumen: Framing Your Role with a Business Context
Ilyssa Levins, Winner of HBA President’s Award and Rising Star
President
Center For Communication Compliance (CCC)

Session 3: Moving from Technical to Strategic Thinking
Catherine Angell Sohn, PharmD, HBA Women of the Year
Dean's Professor; President, Sohn Health Strategies LLC
University of the Sciences

Networking Break

Session 4: Commanding Executive Presence
Karen Hough, Nationally Recognized Author
Founder and CEO
ImprovEdge, LLC

Session 5: Working with or as a Mentor
Hayley A. Norman, Author and Former Pharmaceutical Executive
Managing Member
Metajourn, LLC

What’s more…Receive $100 off of your DIA 2013 Annual Meeting registration by registering for two half day tutorials or one full day tutorial. Please note purchases must be made at the same time in order to receive the discount.

Visit www.diahome.org/DIA2013 for more details on the DIA 2013 Annual Meeting being held June 23-27 in Boston, MA.

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How do you perform Quality Oversight of CROs -Clinical Vendors?

Quality Oversight of CROs-Clinical Vendors
June 23 from 9:00AM – 5:00PM in Boston

FDA and EMA communicate at industry conferences, FDA-CTTI meetings, and regulatory agency public meetings. Sponsors and CRO-vendors who are transferred the responsibilities for trial conduct must have in place a vendor management-oversight program and methods, as well as a quality management system and risk management framework for the execution of clinical trials. Building upon this framework and benchmarking to ISO-9001: 2008, Quality Management Systems, this tutorial describes Quality Oversight of Vendors, with the focus on quality systems, quality attributes, and performance monitoring.

Instructor(s):
Liz Wool, BSN,RN
President and Chief Executive Officer
QD-Quality and Training Solutions Inc., United States

Jennifer J Poulakos, PhD
Director, Clinical Quality Assurance
Astellas, United States

Jeffery Baldwin, BSN,RN
Senior Manager, Supplier Governance
Amgen, United States

What’s more…Receive $100 off of your DIA 2013 Annual Meeting registration by registering for two half day tutorials or one full day tutorial. Please note purchases must be made at the same time in order to receive the discount.

Visit www.diahome.org/DIA2013 for more details on the DIA 2013 Annual Meeting being held June 23-27 in Boston, MA.

Sign up for DIA's Global SmartBrief eNews for the latest in drug development innovations worldwide.

What are the best practices in patient recruitment, budgets and contracts, and FDA audit readiness?

Investigative Site Boot Camp: Innovative Solutions to your OperationalChallenges
June 23 from 1:00PM – 6:00PM in Boston

This boot camp was designed for site personnel to address the state of the industry, trends impacting sites and highlight ways to overcome these recent challenges. Industry leaders will share insight to help sites position for future work. Moderators will facilitate this communication to allow sites an open exchange of best practices and innovative solutions to patient recruitment, budgets and contracts, and FDA audit readiness.

Instructor(s):
Christopher J. Hoyle, MBA
Executive Director
Elite Research Network, United States

Deena E. Bernstein,
Director of Clinical Research
Sheridan Clinical Research, United States

Representative Invited
Head of Site and Patient Networks; Site Optimization
Genzyme Corporation, A Sanofi Company, United States

Representative Invited
Principal Attorney
The Kulkarni Law Firm, United States

Alison Duhamel, MA
Senior Manager, Site Contracting, Clinical Site Services
Vertex Pharmaceuticals, United States

What’s more…Receive $100 off of your DIA 2013 Annual Meeting registration by registering for two half day tutorials or one full day tutorial. Please note purchases must be made at the same time in order to receive the discount.

Visit www.diahome.org/DIA2013 for more details on the DIA 2013 Annual Meeting being held June 23-27 in Boston, MA.

Sign up for DIA's Global SmartBrief eNews for the latest in drug development innovations worldwide.

How does Risk Communication differ in US and EU?

Risk Communications
June 23 from 9:00AM – 5:00PM in Boston

This tutorial teaches risk management best practices to optimize medical product safety. Participants will learn proven strategies to improve product safety, maximize patient benefits and minimize risk.

Instructor(s):
Nancy D. Smith, PhD
Adjunct Professor at Temple University
FDA Alumni, United States

What’s more…Receive $100 off of your DIA 2013 Annual Meeting registration by registering for two half day tutorials or one full day tutorial. Please note purchases must be made at the same time in order to receive the discount.

Visit www.diahome.org/DIA2013 for more details on the DIA 2013 Annual Meeting being held June 23-27 in Boston, MA.

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How is translational medicine defined globally? What are the potential benefits for industry and academia?

Understanding Translational Medicine: Benefits and Innovative Approaches
June 23 from 1:00PM – 4:30PM in Boston

This tutorial will help the professionals working at various positions in the pharma, biotech, medical device industries and academia to better understand translational medicine. Translational Medicine has great potential to enhance health care starting from prevention, diagnosis, and drug/device developments for clinical disorders. However, there are few clinician/scientists critically trained in translational research and more programs to foster their development are required. This tutorial will provide an overview of the translational medicine field including definitions and concepts, potential benefits as well as global initiatives and programs.

Instructor(s):
Aamir Shahzad, MD
President
European Society For Translational Medicine (EUSTM), Austria

What’s more…Receive $100 off of your DIA 2013 Annual Meeting registration by registering for two half day tutorials or one full day tutorial. Please note purchases must be made at the same time in order to receive the discount.

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How are comparative effectiveness research and HTA applicable to the biopharmaceutical industry?

Understanding Comparative Effectiveness Research (CER)/Health Technology Assessment (HTA) inthe Biopharmaceutical Industry

June 23 from 1:00PM – 4:30PM in Boston

Health care reform has amplified interest in Comparative Effectiveness Research (CER)/Health Technology Assessment (HTA). CER/HTA may sound threatening without a realistic context for what it is, how it has evolved, what it is intended to do and its limitations. A brief introduction and overview of CER/HTA will be presented through lecture, interactive discussions and case study. This tutorial will present a perspective of CER/HTA in the context of clinical trials and health care policy and provide timely insights for today’s biopharmaceutical professionals.


Instructor(s):
Nancie E. Celini, DrPH,MPH
Chief Learning Consultant
CAB Inc., United States

Vadim Tantsyura, DrPH,MA,MS
Director, Data Management
Cincinnati Children's Hospital Medical Center, United States


What’s more…Receive $100 off of your DIA 2013 Annual Meeting registration by registering for two half day tutorials or one full day tutorial. Please note purchases must be made at the same time in order to receive the discount.

Visit www.diahome.org/DIA2013 for more details on the DIA 2013 Annual Meeting being held June 23-27 in Boston, MA.

Sign up for DIA's Global SmartBrief eNews for the latest in drug development innovations worldwide.

What current regulatory, global, and public opinion trends have the potential to impact biologics?

Regulatory Affairs for Biologics
June 23 from 9:00AM – 5:00PM in Boston

Participants in this tutorial will learn the differences between traditional biologics and biotechnology products, the regulatory needs and requirements for biologics, the unique aspects in the development of specific biologics such as vaccines and gene therapy, and the different ways that CBER and CDER view product development.

Instructor:
Carol H. Danielson, DrPH,MS
President
Regulatory Advantage, United States

What’s more…Receive $100 off of your DIA 2013 Annual Meeting registration by registering for two half day tutorials or one full day tutorial. Please note purchases must be made at the same time in order to receive the discount.

Visit www.diahome.org/DIA2013 for more details on the DIA 2013 Annual Meeting being held June 23-27 in Boston, MA.

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What are the ethical considerations in conducting clinical research?

Overview of Drug Development
June 23 from 9:00AM – 5:00PM in Boston

This tutorial will provide an introduction to the drug development process under FDA and ICH Guidelines, including how various parts of companies fit into the overall process of pharmaceutical development.

Instructor:
George H. D'Addamio, PhD
President
PharmConsult Inc., United States

What’s more…Receive $100 off of your DIA 2013 Annual Meeting registration by registering for two half day tutorials or one full day tutorial. Please note purchases must be made at the same time in order to receive the discount.

Visit www.diahome.org/DIA2013 for more details on the DIA 2013 Annual Meeting being held June 23-27 in Boston, MA.

Sign up for DIA's Global SmartBrief eNews for the latest in drug development innovations worldwide.