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

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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Calling all Life Science Students

Your Roadmap to Success Looking for ways to leverage your education and land a career in the life sciences industry? Then you must attend the DIA 2013 49th Annual Meeting. For only $250, you can network with more than 7,000 life sciences professionals involved in the discovery, development, and life cycle management of pharmaceuticals, biotechnology, medical devices, and related products to unlock the innovation needed to expand global access to effective and affordable patient care.. Get your name alongside top thought leaders, innovators, and experts all seeking fresh knowledge and sharpening their skills for the future. You must be registered by May 17  to make the Advance Attendee List which is distributed to all participants. Download Registration Form Eligibility Students must be an undergraduate or graduate student who can document that they are enrolled in a degree granting or certificate-granting academic program in an accredited academic institution, whose content is consistent with the mission of DIA for at least 12 undergraduate hours annually or 9 graduate hours annually.     4 Days. 22 Tracks. 250+ Educational Offerings. 450+ Exhibitors. 7,000+ Attendees. Student Forum “Getting a Job and Developing a Career” June 25 | 10:15-11:45AM ET This year’s forum will cover getting a job with presentations on soft skills, interviewing and using internships and fellowships to launch your career. An additional topic - finding a mentor - will introduce the theme of going from finding a job to developing a career. A good mentor can guide you with priceless tacit knowledge that otherwise could take years to find. Speakers: Soft Skills and Interviewing Kelleen Flaherty, MS, Assistant Professor, University of the Sciences in Philadelphia Using Fellowships and Internships to Start Your Career Justin Balint, PharmD, Post-Doctoral Fellow, Oncology Advocacy and Policy, Rutgers Finding a Mentor to Guide your Career Amy N. Grant, MS, Director, Global Regulatory Strategy & Science, ViroPharma Inc. Career Center The DIA Career Center is your go-to resource for careers in the life sciences industry. Use the Career Center to find your ideal job or internship today! Continuing Education Credits Earn CE credits for attending sessions, forums, workshops, symposia, and more Network!  Network!  Network! Receptions, Networking Lunches, Student & Professional Posters, Speed Networking Session View This Year's Student and Professional Posters Student Group Discounts Available! Register 10 from your university and receive the 11th FREE! Contact Donna Mayer at donna.mayer@diahome.org         for eligibility and registration details.

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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

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.

Clinical Safety and Pharmacovigilance Track at DIA2013

 

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

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

How does Risk Communication differ in US and EU?

What is the likelihood ratio test-based signal detection method for FDA’s AERS database?

What is the EMA doing to improve benefit-risk assessment of medicines?

What are the current challenges in monitoring BP through the different indications and in the different trial phases?

What are differences in legislation for risk management between the US, EU and Japan?

How can coding with MedDRA® improve clinical safety data?

What are recent innovations driving patient-focused approach to benefit-risk in Canada?

What is the relevance and application of drug interaction predictive models to clinical development?

How can I obtain higher-quality narrative information from patients through traditional and new media?

How can I generate metrics for the effectiveness and efficiency of a signal detection program?

How do I use social media, mobile apps and patient support programs for pharma and biotech industries?

What is the ongoing international standardization work on ICSR and IDMP?

What are recommendations from projects of the Clinical Trials Transformation Initiative?

How can I anticipate factors that may increase the incidence of drug shortages in the future?

What are the initiatives using electronic health records for drug safety signal detection and evaluation?

How can Herbal-induced Organ Toxicity impact Rx Benefit-risk?

How do I compile a PSUR according to the new EU and ICH guidance?

What are latest developments in pharmacovigilance in the developing countries of Asia and Latin America?

What are the current methods of tracking misuse and abuse of marketed pharmaceuticals?

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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

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'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.

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.

Medical Communication, Medical Writing, and Medical Science Liasion Track at 49th DIA Annual Meeting

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

What do you need to prepare clinically-focused Module 2 Summaries of an eCTD-based Submission?

Do you know the similarities and differences between global regulatory guidelines covering medcomms?

How does China’s rapidly increasing contributions to medical research affect medcomms around the world?

What are the MedComm opportunities before launch of a new drug/device combination product?

MedComms symposium ~ How do  FDA MedWatch, EMA, and REMS affect your work?

How do you Maximize Efficiency and Minimize Redundancy in Clinical Study Reports and Summary Docs?

How can a medical writer’s perspective improve data collection and analysis tools?

Are your Industry-sponsored pubs and MedComms Corporate Integrity Agreements aligned with OIG?

What best practices for cross-functional interactions produce value added deliverables?

What's best practice in utilizing the modular approach to PSURs, DSURs and RMPs?

Regulatory Writing JEOPARDY! Test your knowledge of regulatory documents, from the mundane to the exotic.

What are the challenges of adopting technology and social media for MedComms?

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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

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 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

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.

For our friends in Europe, we kindly suggest the following sessions at #DIA2013 in Boston, MA.

For our friends in Europe, we kindly suggest the following sessions at this year's annual meeting in Boston, MA.

Challenges for Stable Supply of Drugs and International Cooperation

What is the current drug supply situation in US, EU and Japan?

European Town Hall: Implementation of New Safety Legislation and Other Hot Topics

European Town Hall: Implementation of New Safety Legislation ~ #CHMP #CMDh
Cooperation Among Regulators: Impact on Stakeholders             
What is the impact of cooperation among drug regulators on organizations on stakeholders?

US and EU Regulatory Update of Clinical Trial Disclosure                

What are patients’ expectations about clinical trials and registries/results databases?

Risk Management in the US, EU and Japan: The Challenges of Diversity

What are differences in legislation for risk management between the US, EU and Japan?

Learnings from Safety Communications Across the Industry: Patients and EMA, REMS, and FDA, Physicians, and Medical Information Groups

#MedComms symposium ~ How do FDA MedWatch, EMA, and REMS affect your work?

 

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For our friends in China, we kindly suggest the following sessions at #DIA2013 in Boston, MA.

For our friends in China, we kindly suggest the following sessions at this year's annual meeting in Boston, MA.

Global Clinical Trials: The Role of Emerging Markets         
What are the areas of potential risks when undertaking global clinical trials in emerging markets?
Convergence in Regulatory Science Across the Strait
What are areas of convergence in regulatory science between CDE-China and CDE-Taiwan?
GCPs in Emerging Countries
What are the GCP quality trends in US and emerging countries?
Pharmacovigilance Update for Japan, Developing Asia and Latin America
What are latest developments in pharmacovigilance in the developing countries of Asia and Latin America?
A Regulatory Perspective of Biosimilars in Emerging Markets
What are similarities/differences in biosimilar regulatory requirements in APAC and Latin America?

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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.

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 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.

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.

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.

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.

For our friends in India, we kindly suggest the following sessions at #DIA2013 in Boston, MA.

For our friends in India, we kindly suggest the following sessions at this year's annual meeting in Boston, MA.

Global Clinical Trials: The Role of Emerging Markets         

What are the areas of potential risks when undertaking global clinical trials in emerging markets?

GCPs in Emerging Countries

What are the GCP quality trends in US and emerging countries?
Partnering and Outsourcing Challenges in India: The New Paradigm Shifts
Partnering and #outsourcing in India: Strategies for integrating diverse skills around operational deliverables.
A Regulatory Perspective of Biosimilars in Emerging Markets
What are similarities/differences in biosimilar regulatory requirements in APAC and Latin America?


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