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?

 

The 4th Pharmacovigilance Conference in India is now only three days away.

Don’t Miss Your Chance to Exchange Knowledge The 4th Pharmacovigilance Conference in India is now only three days away. Take this opportunity to discuss the latest global challenges in drug safety with professionals worldwide. Professionals attending the two-day conference, to be held in Bangalore from March 8-9, will 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. Read More View Program Register EXHIBITING OPPORTUNITY Download the application for a tabletop display at the event. Other events of Interest Download the India Calendar of Events Conference Highlights Updates on recently released GPvP Modules by EMA Japanese model of EPPV – a way forward for other Asian countries Challenges in authoring PSUR for generic manufacturers An insight into Drug Induced Liver Injury (DILI) Global regulatory compliance: challenges and the way forward Safety regulations in emerging Middle East region Efficient management of literature searching Enhanced productivity and quality through process re-engineering; case studies Global outsourcing trends in PV – Indian potential and challenges by China, Taiwan, and Latin America RSI management – best practices to safeguard against pitfalls Attrition and manpower stability; KPO perspective Technology-watch against safety hazard of spurious and adulterated drugs Training; A Formality or a Reality – an industry insight Panel discussion: compensation for trial related injuries This Pharmacovigilance Conference is perfect for professionals with experience in clinical safety and who are involved in: Pharmacovigilance Clinical research Risk management Compliance Medical information Regulatory affairs Academia Pharmacology Read More View Program Register To know more, contact Manoj.Trivedi@diaindia.org Thank You to our Media Partner

Email Preferences | My DIA | Forward to a Friend |

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.

Don’t Miss the 5th DIA China Annual Meeting The Preliminary Program for the 5th DIA China 2013 Annual Meeting is now available and registration is open. Find the key themes and sessions at this year's event and register early! Register Now View the Preliminary Program PROGRAM CO-CHAIRPERSONS Lingshi TAN, PhD General Manager, Pfizer (China) R&D Co., Ltd. Vice President, Pfizer Worldwide Development Operations, China Yajun ZHAO Director-General, China Center for Pharmaceutical International Exchange(CCPIE), China PROGRAM VICE CHAIRPERSON Dayao ZHAO, MD, PhD Vice President, Janssen Pharmaceutical Research & Development Head of China Research & Development and Scientific Affairs ANNUAL MEETING THEME SNAPSHOT Chemistry, Manufacturing and Controls (CMC) /cGMP Clinical Research and Operations Data Management Drug Safety and Pharmacovigilance Regulatory Science Statistics The Pathway to Success for CROs and SMOs in China Vaccines and Biologics New Programs: SFDA Town Hall Meeting Regulatory and Drug Safety Joint Session: Balancing Risk and Benefit during NDA and Post Marketing Periods Botanical Drug Products in China and the United States Future Oncology Drug Development: Opportunities and Challenges Innovation on Medical Devices and Combinational Products Pharmacoepidemiology – Best Practices and Drug Safety Pharm/Tox Post Approval Studies Development of Novel Traditional Chinese Medicines (TCMs) PRECONFERENCE WORKSHOPS Maximize your learning while attending the 5th DIA China Annual Meeting! Pre-conference workshops include: Analysis of Data Patterns to Monitor and Assess Outcomes of Clinical Studies Drug Substance and Drug Products Stability Requirements and Practice in Early Phase Development Data Management for Oncology Trials Applying MedDRA with Clinical Safety and Pharmacovigilance Practices: Regulatory Perspective Global Clinical Trials - Principles and Case Studies LESS THAN TWO MONTHS LEFT TO SUBMIT YOUR RESEARCH Call for Abstracts Deadline: Monday, February 25 Call for Posters Deadline: Monday, March 25 Click here for information about submission of Abstracts/Posters. CHINA ANNUAL MEETING CONTACTS: China Office: dia@diachina.org XIE Fei: fei.xie@diachina.org HU Rui: rae.hu@diachina.org Tel: +86-10-6260-2240 Fax: +86-10-6260-2201

Email Preferences | My DIA | Forward to a Friend |

Be a Part of Asia’s Most Innovative Regulatory Conference!

Be a Part of Asia’s Most Innovative Regulatory Conference!   OVERVIEW Join health authority representatives and industry professionals from Asian and ICH member countries as they continue to discuss regulatory aspects of ICH, APEC and ASEAN convergence initiatives, good regulatory practices, quality and GMP, global drug development, and pharmacovigilance.   OBJECTIVES This three-day conference offers a unique opportunity for key stakeholders from health authorities, local and multinational pharmaceutical companies, and clinical research to meet and exchange views, discuss topics of interest and identify focus areas for ongoing efforts to increase patient access to new and improved medicines.   This conference will provide a forum to: • Facilitate discussion on common issues in the regulatory and technical areas in Asia • Encourage greater convergence of regulatory requirements in Asia • Strengthen cooperation between Asian regulatory authorities and pharmaceutical industry Day One – Research and Development Day Two – Good Regulatory Practices Day Three – 21st century Global Regulatory Challenges   Register Online     Program Overview     View PDF Program committee chairs Arun Mishra Director Global Regulatory Affairs GlaxoSmithKline, UK John C.W. Lim Chief Executive Officer Health Sciences Authority, Singapore  Who Should Attend Are you a Representative of Health Authorities, a Regulatory Affairs professional, or a professional involved in or interested in the aspects surrounding registration of medicinal products and regulatory convergence initiatives in Asia? If so, then this conference is for you. Ministries of Health and Medicines Regulatory Authorities Regulatory Affairs Clinical Research and Development Safety and Pharmacovigilance Clinical Trial and Project Management CMC/Quality (Quality, Manufacturing and Controls)   Register Online     Program Overview     View PDF To know more contact Ellen.Diegel@diahome.org.