Exclusive Offer to DIA Members: Register for Two Webinars and Save $250.

Exclusive Offer to DIA Members: Register for Two Webinars and Save $250. Busy life sciences professionals need affordable, convenient, and immediate access on the latest developments in the ever-changing health care industry. DIA webinars offer just that - access to timely and authoritative information. Take advantage of this special offer. Offer ends October 18. Check Out These Hot Topics: The Current State of Quality Oversight in the Pharmaceutical Industry October 9 | 11:00AM-12:30PM ET With definitions remaining unclear as to what, exactly, quality oversight (QO) should entail and how optimal quality oversight programs can be effected. This webinar will provide a definition of QO and delve deeper into the state of QO today. Connecting the Right Sites to Promising Trials: The Role of Web-based Feasibility Assessment October 23 | 11:00AM-12:30PM ET This webinar will address common weaknesses in the established process of feasibility assessments and site selection, from the point of view of both trial planners and research centers. The speakers will review relevant key performance indicators (KPIs) and how to address them, global country selection strategies, and better management of site feasibility assessment. FDASIA Year in Review October 24 | 11:00AM-12:30PM ET Hear what FDASIA has given us this past year – and what we might expect in the coming year. This webinar will focus on the progress of the PDUFA V and initiatives to promote innovation and speed to patient access covering: user fee levels, perspective on the new molecular entity review process, status update on Benefit-risk assessment activities, and FDA’s interpretation of the fast track, breakthrough therapy, accelerated approval, and priority review programs. CDER Town Meeting: Safety Hot Topics October 30 | 2:30-4:00PM ET In this interactive webinar, participants will submit questions regarding safety to senior leadership from the US FDA Center for Drug Evaluation and Research through an anonymous, computerized Q&A function. CardioVascular Safety: The New Paradigm - Proarrhythmic Assessment of New Drugs Without the Thorough QT Study October 31 | 11:00AM-12:30PM ET Explore the current approach to assessing the possible proarrhyrhmic potential of drugs and its strengths and weaknesses, a new paradigm that relies more fully on preclinical testing and its advantages and challenges, and key regulatory issues surrounding implementing a new paradigm. CardioVascular Safety – What are the Key Issues Regarding Blood Pressure Assessment During Clinical Development November 7 | 11:00AM-12:30PM ET Explore the current approach to assessing the possible proarrhyrhmic potential of drugs and its strengths and weaknesses, a new paradigm that relies more fully on preclinical testing and its advantages and challenges, and key regulatory issues surrounding implementing a new paradigm. Aligning the Voices of Change in the Health Care System November 12 | 11:00AM-12:30PM ET Several legislations have been introduced calling for regulatory reform in the health care process. FDA is under pressure from industry to enable a regulatory framework for translational medicine but at the same time preserve the public health. This 90-minute webinar will show how important it is for the patient voice to be included when these legislations are drafted. More Upcoming Webinars: Practical Aspects and Examples of Using Large Datasets for Identifying and Investigating Product Safety and Effectiveness in the US and EU November 18 | 11:00AM-12:30PM ET The Case of the New England Compounding Center: Learning from the Tragedy November 19 | 11:00AM-12:30PM ET Social and Collaborative Tools in Regulatory Intelligence November 21 | 11:00AM-12:30PM ET Electronic Submissions 101 – Essential MS Word and Adobe Acrobat Tools/Skills and Current IT Options December 4 | 11:00AM-12:30PM ET Combination Products and Convergence: An Overview of Clinical Benefits, Regulatory Issues & Manufacturing Challenges December 5 | 11:00AM-12:30PM ET Global Overview - Economic Power in Asian Countries December 11 | 11:00AM-12:30PM ET View the Full List of Webinars for Complete Details *Offer only valid for webinars included in this email and cannot be combined with any existing promotions.

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Take advantage of DIA’s live webinars

Stay ahead in your field with DIA's live webinars
Take advantage of DIA’s live webinars to learn about the latest issues in your field. Upcoming webinars include:

• Eight-Part Webinar Series: Assessing the Benefits and Risks of Medicines, Part 5: Stated Choice Methods for Valuing Benefits and Risks (April 24, 11:00 a.m. - 12:30 [p.m. ET)
• Two-part Webinar Series: Impact of the New European Pharmacovigilance Legislation and Important Updates (April 25 and 26, 10:00 a.m. - 11:30 a.m. ET)
• Using Patient-Reported Outcomes to Assess Product Safety and Tolerability: Methodological and Regulatory Considerations (May 17, 11:00 a.m. - 12:30 p.m. ET)

View more upcoming webinars.

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

Global Events - Discuss Critical Issues with Pharma Industry Experts

Discuss Critical Issues with Industry Experts Want to network and exchange knowledge with regulatory agencies from around the world? Then don’t miss the Latin American Regulatory Conference (LARC) 2013. High-profile regulatory agencies will be participating in the meeting, to be held in Bogota, Colombia from May 15-16, to discuss the current regulatory landscape and its impact on future research and drug development. Representatives will be attending from Colombia (INVIMA), Ecuador (MoH), Guatemala (MoH), Chile (ISPCH), Brazil (ANVISA), the USA and Costa Rica (FDA), Canada (Health Canada), Spain (AEMPS), and Peru (DIGEMID). Global organizations including the Pan American Health Organization and the World Health Organization will also be taking part. Find out More Download Program Register now CALL FOR ABSTRACTS worldwide Don’t miss great opportunities to share knowledge with professionals around the globe. Click to Submit In Other News NEW MEMBER BENEFIT FREE Archived Webinars! OTHER EVENTS 6th Regulatory Conference in IndiaMay 23-24, 2013 Ahmedabad, India Asia New Drug Development April 15-16, 2013 Tokyo, Japan DIA/FDA Statistics Forum 2013: PDUFA V Statistical Topics and Emerging New Issues April 28-May 1 North Bethesda, MD Busy professionals need affordable, convenient access to the latest updates in the life sciences industry. That’s why DIA developed comprehensive online training courses and webinars designed for our global audience. Online Training Course: How to Prepare for a Safety Inspection March 26-28 | 11:00AM-1:00PM ET Register by March 22 to Save $100! Enter promo code SAFE at checkout Webinar: CDER – Data Submission 101 March 27 | 10:00-11:30AM ET Online Training Course: Fundamentals of Project Management for the Nonproject ManagersApril 9, 11, 16 & 18 | 12:00-1:30PM ET Online Training Course: Strategies for Comparative Effectiveness Research for Regulatory, Compliance and Legal Professionals in Life Sciences Promotion April 23 | 11:00AM-12:30PM ET Register for multiple courses in this CER series and save up to 20%! Two-Part Webinar Series: Impact of the New European Pharmacovigilance Legislation and Important Updates April 25-26 | 10:00-11:30AM ET Webinar: A Closer Look at FDASIA Provisions to Promote Biomedical Innovation April 29 | 1:00-2:30PM ET Book by April 22 for Early-bird Savings Register for the 5th DIA China Annual Meeting before April 22 to save with our early-bird discount. The conference, to be held in Beijing from May 12-15, will feature more than 40 sessions and 14+ tracks on hot topics from key opinion leaders in the global pharmaceutical industry, government agencies, and life sciences organizations. Global expansion, regulatory affairs, clinical research, pharmacovigiliance, and traditional Chinese medicines will be discussed in presentations and sessions at the event, focused this year on “Patient Safety – A Sustained Focus from Scientific Ideas to Innovative Medicines.” Read More Register

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What the Biopharmaceutical Industry Needs to Know in the Wake of the Supreme Court Decision Upholding the Affordable Care Act

No Worries, We Recorded it Will the PhRMA Deal Stand and What Happens Next? What the Biopharmaceutical Industry Needs to Know in the Wake of the Supreme Court Decision Upholding the Affordable Care Act July 26 This 90-minute archived webinar lets you hear experts cut through the hype to consider the real effects of the decision on the drug, device and biopharmaceutical industries. Among other things, panelists discussed how states may limit the expansion of Medicaid and how that may affect the PhRMA deal with Congress, including the $80 Billion contribution in exchange for additional patients with Part D coverage. At the conclusion of this webinar, you will be able to: • Explain the effects of the Affordable Care Act decision on the medicine companies, especially its affect on Medicare Part D covered recipients and the biopharmaceutical industries • Discuss how the decision may impact the development of biosimilars • Discuss the options and possible political outcomes as health care reform evolves, including likely legislation next year important to the biopharmaceutical and related industries Moderator: • John F. Kamp, JD, PhD, Executive Director Coalition for Healthcare Communication Presenters: • Peter J. Pitts, President, Center for Medicine in the Public Interest • Arnold I. Friede, Former FDA Associate Chief Counsel, Principal, Arnold I. Friede & Associates • Richard Manning, PhD, Partner, Bates White Economic Consulting Please Note: Continuing education credits are not available for archived webinars. Overview | Register The Patient-Centered Outcomes Research Institute’s National Priorities and Research Agenda Biosimilar Guidances: Explanation and Discussion: Part 1 and Part 2 Meeting Global Patient Demand for Access to Medicines Prior to Approval and Launch Two-part Series: Impact of the New European Pharmacovigilance Legislation on International Companies View the Full List of Archived Webinars. Questions on Archived Webinars? Contact: Carolyn Callahan

Upcoming DIA Webinars: FDA draft guidance on Biosimilars

On February 9, US FDA released three draft guidances to address biosimilar biological drug products. These guidances are intended to assist industry to reduce the burden of development of pharmaceuticals that are biosimilar to approved biological products.

PART 1:  #12215

This initial webinar will introduce biosimilars and describe the content of the Questions & Answers and present the components of the Scientific Concepts document. The presenters will suggest approaches that might be useful in satisfying the respective areas of the guidance: legal/regulatory, preclinical and clinical components of a biosimilar program. Focus will be on: explaining the actual document, considering ways that the guidance may be satisfied and possible alternatives to the suggested approach.

Links to the Biosimilar Draft Guidances that Part 1 will address:

 

• Scientific Considerations in Demonstrating Biosimilarity to a Reference Product
• Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act 2009

PART 2: #12216

This webinar will focus on Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product. The guidance lists principles and factors that should be considered and these will be discussed. Some in vitro comparisons that will be useful in demonstrating similarity between a biosimilar product and its approved reference will be discussed in the context of the guidance.

Link to the Biosimilar Draft Guidance that Part 2 will address:

• Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product