Insights From Canada’s Thought Leaders on Patient’s Voice, Plain Language Labeling Project, Pharmacovigilance

Exclusive Scoop from Canada's Key Thought Leaders       In this edition of the Insider Update you’ll hear insights from Canada’s key industry thought leaders regarding the impact of patient’s voice in the ever changing regulatory environment, the emerging areas of change in Pharmacovigilance in Canada, and what international regulatory cooperation means to key stakeholders in the development and regulation of health products. In addition, we will address the need to provide the patient and the health care professional with increased accessibility to drug information and comprehension of drug labels, plus more.   “Those who are in the pharmaceutical industry and those in the regulatory realm need to acknowledge the patients’ voice and perspective." "New approaches and collaborations are required to keep up with the realities of the pharmaceutical industry today..." Get the Insider Scoop NOW!    Read More Insider Update

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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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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

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6th Regulatory Conference - India - April 5-6

Hear from prominent presenters on the latest regulatory issues Rajiv Gulati President Global Pharmaceuticals Business, Ranbaxy Laboratories Limited G. N. SinghDCGI (Drug Controller General of India) High-profile speakers and attendees will discuss the challenge of ever-evolving regulation at the 6th Regulatory Conference in India. The conference, to be held in Ahmedabad, Gujarat from April 5-6, will feature keynote speaker Rajiv Gulati, President Global Pharmaceuticals Business, Ranbaxy Laboratories Limited, presenting on the theme “India, the Upcoming Economy: Encouraging Enforcement of Regulations.” Also participating will be the Drug Controller General of India (DCGI), Dr. G. N. Singh. The two-day event will bring together prominent industry experts, senior management professionals, academicians and regulators to share the knowledge they’ve gained from decades of experience and note-worthy contributions to the development of the Indian pharmaceutical industry. Read More Register Other events of Interest Download the India Calendar of Events Who Should Attend Professionals in: Regulatory Affairs from Government and Industry Clinical Research and Development Safety and Pharmacovigilance Clinical Trial and Project Management CMC/Quality (Quality, Manufacturing and Controls) QA and QC Product Development Read More Register To know more, contact Manoj.Trivedi@diaindia.org Thank You to our Media Partners

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