Clinical Project Management Training course Mexico City on November 7

Get the Latest Expert Advice in Managing a Clinical Trial There’s just one month to go until the Clinical Project Management Training course, to be held in Mexico City, Mexico on November 7. Attend this training course to learn how to define the scope of interventional and observational clinical studies, evaluate the main requirements, and identify suppliers for the feasible conduction of a clinical trial. Participants will also develop an understanding of the global regulatory framework and its application to accomplish a successful clinical study. Find out More Download Program Register Session highlights: Drug Development Global Regulatory Framework Clinical Studies in Latin America Role of the Study Manager Clinical Study Management Clinical Data Management Safety Find out More Download Program Register

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Pharma professionals, looking for CE credit from PMI?

CONTINUING EDUCATION

The DIA 2013 49th Annual Meeting is the premier event for professionals involved in the discovery, development, and life cycle management of pharmaceuticals, biotechnology, medical devices, and related products.

http://www.diahome.org/en-US/Flagship-Meetings/DIA2013/Meeting-Program/Continuing-Education-Credits.aspx

• Title: #25: Leadership: How to Organize and Lead People in Group Work
  Event Type: TUTORIAL
  Credits: IACET, PMI                                   
• Title: #55: Overview of Drug Development
  Event Type: TUTORIAL
  Credits: IACET, PMI                                  
• Title: Shape Your Cost with Hard and Soft Coverage Analysis Trends
  Event Type: WORKSHOP
  Credits: CME, IACET, PMI, RN                                     
• Title: Portfolio Management Symposium
  Event Type: SYMPOSIUM
  Credits: IACET, PMI
• Title: The State of Clinical Outsourcing: Managing Risk in Outsourced Clinical Trials
  Event Type: FORUM
  Credits: CME, IACET, PMI, RN                                                             
• Title: Bridging the Gap Between Strategy and Execution
  Event Type: SYMPOSIUM
  Credits: CME, IACET, PMI, RN                                                              
• Title: Taking the Measure of Metrics
  Event Type: SYMPOSIUM
  Credits: CME, IACET, PMI, RN                                                                      
• Title: Pharma, Academia and CRO Preferred Partnerships: Why Collaboration Makes a Better Global Trial
  Event Type: FORUM
  Credits: CME, IACET, PMI, RN                                                                      
• Title: Innovative Computerized System Validation and Auditing
  Event Type: FORUM
  Credits: CME, IACET, PMI, RN                                                                      
• Title: Domestic and Global Trends in Clinical Trial Budgeting
  Event Type: WORKSHOP
  Credits: CME, IACET, PMI, RN                                                                      
• Title: Change Order Panel Discussion and Brainstorming Session: Can We Be More Efficient?
  Event Type: FORUM
  Credits: CME, IACET, PMI, RN                                                                      
• Title: Evaluating Sites for Optimum Site Selection and Performance
  Event Type: SESSION
  Credits: CME, IACET, PMI, RN                                                                      
• Title: How Strategic Is Strategic Outsourcing, and for Whom?
  Event Type: SESSION
  Credits: IACET, PMI                                                                      
• Title: Is This Trial Worth It? A Panel Discussion for Sites and Project Managers
  Event Type: SESSION
  Credits: CME, IACET, PMI, RN                                                                      
• Title: Careers Beyond Project and Portfolio Management: A Panel Discussion
  Event Type: FORUM
  Credits: IACET, PMI                                                                      
• Title: Making CRO-Sponsor Partnerships Work: Executive Roundtable
  Event Type: FORUM
  Credits: IACET, PMI                                                                      
• Title: Using Competence Models to Drive High Quality Drug Project Management
  Event Type: SESSION
  Credits: CME, IACET, PMI, RN                                                                      
• Title: Towards an Effective Virtual R&D Team for Faster Accessing of the East Asian Market
  Event Type: SESSION
  Credits: CME, IACET, PMI, RN                                                                      
• Title: Innovative Strategies for Evolving Sponsor, CRO and Site Alliances
  Event Type: SESSION
  Credits: IACET, PMI                                                                      
• Title: Pharmaceutical Project Management: What's Really Important and How Can We Do Better?
  Event Type: SESSION
  Credits: IACET, PMI                                                                      
• Title: Partnering and Outsourcing Challenges in India: The New Paradigm Shifts
  Event Type: SYMPOSIUM
  Credits: CME, IACET, PMI, RN                                                                      
• Title: Data Standards Strategy
  Event Type: SESSION
  Credits: CME, IACET, PMI, RN                                                                      
• Title: Cost Management for Global Drug Development Projects
  Event Type: SESSION
  Credits: CME, IACET, PMI, RN                                                                      
• Title: Transforming Relationships to Adapt to Evolving Organizational Strategic Goals
  Event Type: SESSION
  Credits: CME, IACET, PMI, RN                                                                      
• Title: Strategic Partnerships: Emerging Models and Their Impact on Drug Development
  Event Type: FORUM
  Credits: CME, IACET, PMI, RN

 

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Project/Portfolio Management Track at DIA's 49th Annual Meeting

 

• Effective Diverse Team Collaboration and Management for drug development: East meets West  
• So you want to be a pharma Project Manager?
• What are the requirements for submissions to HTA organizations that affect the drug development team?
• What is the importance of proactively leveraging country selection to support marketing plan objectives?
• How do large and small pharma companies develop orphan drug commercialization strategies?
• Interactive Workshop ~ What are the process and decisions made during Phase 2 drug development?
• Interactive Workshop ~ What are the factors influencing a decision to file for an NDA?What are the key aspects in developing and managing budgets for global drug development projects?
• Where will your project/portfolio management role lead you?
• How do you navigate potential Regulatory land mines in Due Diligence?
• What PM practices are most critical to project success in  biopharma industries?
• How can you influence your organization to create and adopt project management competencies?
• What are financial, resource and planning challenges of Incorporation of Mandatory Language into protocols?
• How can adopting an Adaptive Design Strategy help you Manage Portfolio Risk and Value? Using Innovation to Bridge the Gap Between Strategy and Execution
• How does application of pharmacometrics affect range of drug  development and decision-making activities?
• How are drug development approaches being adopted by companies that develop biosimilars?
• How will Clinical Trials Transformation Initiative’s potential methods apply to QbD?
• What techniques and tools can be used to apply QbD in designing and running clinical development programs?

 

Upcoming DIA Events in Europe, India, Japan and China

From DIA

China   Training Course: Risk-based Manufacture of Pharmaceuticals: Toxicology and Critical Thinking March 9 | Beijing, China Find out how to better manage risk in the manufacture of pharmaceutical products. This one day session will show you how to use risk assessment for decision-making and also for setting health-based limits. Case studies and examples from a wide variety of fields will be used. There will also be a discussion on effective risk communication.   Europe   25th Annual EuroMeeting March 4-6 | Amsterdam, The Netherlands More than 3,000 professionals involved in the development of medicines from more than 50 countries will gather in Amsterdam at EuroMeeting 2013. The event will feature more than 110 sessions, 200 exhibitors and speakers from the European Medicines Agency, the European Commission, the Food and Drug Administration and other regulatory agencies from around the world.   India   4th Pharmacovigilance Conference in India March 8-9 | Bangalore, India Gain useful new insights into the latest global challenges in drug safety, learn about current global safety reporting requirements for prescription and over-the-counter drugs and discuss new, pragmatic approaches to pharmacovigilance. Other key topics will include the regulatory agency clinical safety and pharmacovigilance inspection program in the US, Europe, and Japan, and identifying best practices for quality assurance in post-marketing pharmacovigilance and clinical safety.   6th Regulatory Conference in India April 5-6 | Ahmedabad, Gujarat, India Remaining competitive in the world market despite ever-evolving regulation is the hot topic at the 6th Regulatory Conference in India. The two-day event, entitled ‘India, the Upcoming Economy: Encouraging Enforcement of Regulations’, will bring together the region’s best talent in the pharmaceutical world to understand what the challenges are and how to face them.   Japan   2nd Project Management Training Course in Japan February 20-21 | Tokyo, Japan A fundamental project management training course on pharmaceutical development. Participants will learn essential and logical techniques of communication, risk management and project team management.   3rd Labeling Workshop in Japan March 16 | Tokyo, Japan How do patients respond to medicine labels? Could the safety messages be clearer? Find out through real examples and prescribers’ views at the 3rd Labeling Workshop. The session will also share information on the experiences of pharmaceutical companies, medical institutes and pharmacists. Submit your abstract for Cardiac Safety Workshop   Call for Abstracts 4th Cardiac Safety Workshop in Japan July 11-12, 2013 | Ivy Hall, Tokyo To submit an abstract for the DIA Cardiac Safety Conference please go to the DIA website: Submission Deadline: February 28, 2013 | Author Notification: March 31, 2013.

第2回 DIAプロジェクトマネジメント・トレーニングコース

 プログラムを見る

本トレーニングコースは、医薬品開発全般におけるPM業務の基本的な講座です。

極めて不確実性の高い医薬品研究開発を効率的かつ効果的に進めていくために、プロジ

ェクトマネジメント（PM）の概念が製薬企業にも必要であるとの認識は広まってきましたが、

その手法や考え方に関しては、各社様々あり、一定のコンセンサスを得る状況にはありま

せん。

一方で、十分なPMの知識・トレーニングがなされないまま、形だけ既存の組織への適合・適

応を行うことで、PM機能が十分発揮できなかった、むしろ非効率となり結果的にPMの導入

に失敗したケースも散見されています。更に各社独自の用語の適用や概念のカスタマイゼ

ーションにより、グローバル開発や複数企業による共同研究開発において、様々な混乱や

ミスコミュニケーションをもたらしている問題点も指摘されています。

本講座では、DIA米国のPM基本トレーニングプログラム資料を用い、製薬企業における研

究開発PMに深い経験と認定資格も持つ４人の日本人講師から、グローバルで基準となる

PMの知識・技法の基本を学びます。また、日本発のPM（グローバルならびにローカルプロ

ジェクト）について概括します。

Network and Learn with Peers at DIA’s Project Management Interactive Workshop - Sao Paulo, Brazil

Network and Learn with Peers at DIA’s Project Management Interactive Workshop DIA and SBMF are proud to announce our new tutorial on Project Management to be carried out  for the first time in Sao Paulo Brazil. Tutorial:  Project Management Training  Date of Program: November 5th - 7th, 2012 Location of Program: Travel Inn in São Paulo, Brazil Program Schedule: Day 1, 2 and 3 - DIA Project Management Training Professor: Joan Knutson, President,  PM, Guru Unlimited, San Francisco, CA, USA Continuing Education Credits: Name Credit Type Max Credits CEU Project Management IACET 18.50 1.9000 Project Management PMI 18.50 0.000  Read More DIA World Wide Executive Director Paul Pomerantz Advisory Council for Latin America Chair Sergio Guerrero, MD SBMF President, Joao Massud Filho, MD Vice-President Gustavo Kesselring, MD Treasurer Charles Schmidt, MD.  OTHER DIA EVENTS Overview Walk away from this course being able to produce a defensible schedule, a solid staffing plan, a well-thought-through budget, and a practical risk response plan applicable in the biotechnology, pharmaceutical, and medical product world. Learning Objectives Participants who complete this course should be able to: Describe the five project management process groups: initiating, planning, executing, monitoring and controlling, and closing the project Apply practical project management best practices Recognize and apply project management tools and techniques to the part of the industry in which you are engaged Discuss how to motivate your team; even if it is virtual What You Will Learn Initiating projects Planning projects Executing and controlling projects Risk management Project team dynamics Closing projects Who Should Attend New and experienced project managers Clinical project managers Project practitioners Operational managers Developmental project managers Chemistry, Manufacturing and Control project managers CRAs and LCRAS looking to improve their careers DIA is a  nonprofit charitable and educational association, tax exempt in the United States under Section 501(c)(3) of the Internal Revenue Code, whose purposes are to share information that optimizes the process of drug development and lifecycle management by providing global and regional forums for the exchange of information, education, and training and extensive multidisciplinary networking opportunities. SBMF is a non-profit organization and its mission is the promotion of knowledge and skills for those who work with Pharmaceutical Medicine providing scientific and correct use information for healthcare products, for the benefit of patients and society. For Further Information please contact: In Sao Paulo: Dr. Charles Schmidt, Treasurer, SBMF charles.schmidt@eurotrials.com In Washington DC: Alejandro Bermudez-Del-Villar, M.A. Alejandro.Bermudez@diahome.org  Latin America & Global Program Development Coordinator 1000 Connecticut Avenue, NW Suite 900 Washington, D.C., 20036 USA  Read More Email Preferences    |    My DIA    |    Forward to a Friend    |