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PK/PD Modeling and Simulation to understand the disposition and preclinical-to-clinical translation of Antibody Drug Conjugates

This webinar presents : -Introduction to Antibody Drug Conjugate (ADC) -Development of mechanistic PK/PD model for preclinical-to-clinical translation of ADCs -Application of PK/PD modeling to understand the disposition of ADCs and guide the development of ADC

Speaker:

  • Dhaval Shah,PhD, MS Pharmaceutics, Assistant Professor, Department of Pharmaceutical Sciences, University at Buffalo, The State University of New York
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April 23/ 2014

Mobile Medical Applications-Understanding the User Interface on Mobile Device

The Mobile platforms are user-friendly tools with powerful computation readily available. Innovators are developing mobile apps to leverage the ubiquitous access to information, computational power and integrated sensors offered by mobile platforms. These features whet strongly the appetite of healthcare providers, eager of mobile apps capable of improving & facilitating delivery of patient care.Topics for discussion are: -Common User Interface Issues -Challenges in implementing mobile medical application interfaces -Understanding Device-User Interface -Human Factors of Device use. Speaker:

  • Frederic Ehrler, R & D Developer,Division of Medical Information Sciences,HUG, Geneva University Hospitals,Switzerland
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April 16/ 2014

Pharmacovigilance in APAC: An Update and Focus on India (PvPI)

This webinar will focus on APAC and the following topics: -Understanding GVP – New GVP Guideline by EMA & its impact -Patient Data Collection System – Reviewing the challenges of complying with changing country regulations in Asia/India -Overview and major achievements of PvPI ( Pharmacovigilance Program of India) Speaker:

  • Michal Borawski, International Pharmacovigilance Officer for the Asia-Pacific Region, Sanofi Pasteur
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March 13/ 2014

Sunshine Act, CMS Mandatory Reporting Requirements & Baseline Testing

Section 111 of the Medicare, Medicaid, and SCHIP Extension Act of 2007 adds new mandatory reporting requirements for group health plan (GHP) arrangements and for Liability Insurance (including Self-Insurance), No-Fault Insurance, and Workers’ Compensation. Failure to comply can subject any company to “double damages.” The Smart Act which went into effect 1/1/13 now adds additional burdens of related conditions. In this webinar, you will learn what an employer can do with baseline testing.Speaker:

  • MaryRose Cusimano-Reaston, Ph.D.,Founder and Chief Science Officer, Emerge Diagnostics, Tulsa OK
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March 12/ 2014

Alternatives To Animal Testing Methods

In this webinar, the presenters discuss scientific and ethical imperatives associated with the use of animals in experiments and testing, and examine burgeoning alternatives to animal research.Speaker:

  • Dr.Aysha Akhtar,Fellow, Oxford Centre for Animal Ethics; Medical Officer, Food and Drug Administration (FDA)
  • Dr.Toby Gill Independent Nanotechnology Professional, UK
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February 27/ 2014

Nonclinical and Clinical Safety Assessment of Biosimilars Part 2 : Regulatory Perspective

In this webinar is a discussion on EMA and FDA regulatory perspectives on nonclinical and clinical safety assessment in biosimilars.Speaker:

  • Dr. Joerg Bluemel,Director Toxicology within Biologics Safety Assessment / Translational Sciences MedImmune, Gaithersburg MD
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February 20/ 2014

Pharmacovigilance : ADR Management and Reporting & Outsourcing Trends

In this webinar, the presenters discuss on Adverse Drug Reaction Management and Reporting: Key Requirements/ Timeliness for expedited reporting / Reporting to EudraVigilance and on Pharmacovigilance Outsourcing Trends:Brief insights into the role of Pharmacovigilance throughout the product life cycle from clinical development to patient care/ Presenting a PSUR to external regulatory authorities .Speakers:

  • Dr. Marcin Marciniak, Director Drug Safety & Pharmacovigilance, PregLem SA (member of Gedeon Richter group) “Adverse Drug Management and Reporting”
  • Dr.Philip Jones, BMBS, MA, MSc, PhD, Associate Director & Deputy QPPV, Symogen Limited “Pharmacovigilance Outsourcing Trends” More Info
December 4/ 2013

The Evolving Role of Global Medical Affairs

This webinar is an Interactive learning opportunity to share, and discuss on the Importance to have an independent Medical Affairs Strategy that is aligned with business and what are the key steps involved in strategic planning process, associated tools and templates? .Speaker:

  • Ramin Farhood, PharmD, MBA Senior Director, Global Head Medical Affairs Operations, Baxter BioScience More Info
November 1/ 2013

Risk Based Monitoring

In-depth discussion on 1.Ensuring the rights, safety of trial subjects 2.Data integrity & management 3.How much monitoring of clinical trial sites is necessary to ensure quality, compliance, and safety of research participants? 4.How to go from 100% source data verification to a risk-based monitoring 5.Increasing the effectiveness of clinical trial site monitoring 6.Cost reduction and improved data quality?.Speaker:

  • Mark Travers, VP, Head of Clinical Study Units at Sanofi-Aventis More Info
October 10/ 2013

Sustainability in Cold Supply Chain & Green Logictics

The high value of the products and the complexity of the global supply chain usually deems the risk of losing product due to temperature excursions as high and what follows is an over-design of shipping containers. Over-designed shipping containers usually bring not only a higher logistics cost but also higher emissions and waste.This webinar focuses on sustainability efforts that can be applied immediately to any cold chain supply and also discusses common misconceptions and organizational silos found in cold chain supply.Speaker:

  • Carlos Castro,Clinical Supply Chain, Gilead Sciences More Info
September 23/ 2013

Nonclinical and Clinical Safety Assessment of Biosimilars: Status and Perspective

The development of biosimilars has gained momentum in recent years due to upcoming patent expiry of first generation Biologics and increasing financial pressure on health care systems.The webinar reviews the current regulatory landscape and guidance for nonclinical and clinical development of biosimilars with a focus on safety-related aspects and discuss the current challenges and future perspectives in this area. Speaker:

  • Joerg Bluemel,Director Toxicology within Biologics Safety Assessment / Translational Sciences,MedImmune, Gaithersburg MD More Info
July 25/ 2013

Navigating the Dynamic Indian Clinical Trial Landscape

India’s vast and growing population means the clinical trial business can potentially be worth up to a billion dollars per year by 2016! With this opportunity, the Indian government is taking serious action to better regulate and oversee the clinical trials the process. This presentation will examine:Recent changes in Indian clinical trial regulations,Immediate and long term impacts,Foreseeable opportunities.Speaker:

  • Dr. Josemund Menezes, MBBS,Regional Director, Clinical Development (Asia-Pacific), Sanofi Pasteur More Info
June 28/ 2013

Drug Advertising & Promotion Labeling:FDA Regulations

This webinar will examine the history of FDA oversight of pharmaceutical advertising and promotion, and review the basic FDA regulations and guiding principles. Viewers will learn how to apply these principles through real world case studies and FDA enforcement examples. The fundamentals on FDA regulations and guidance related to prescribed drugs-advertising and promotional labeling,Assessing traditional and newer forms of promotional materials for compliance Pharmaceutical social media advertising for approved drugs,Pre-approval communications (ie how to communicate about a drug without promoting it prior to FDA-approval) Speaker:

  • Moulakshi (Mou) Roychowdhury, PharmD, JD Director of Regulatory Affairs – Global Advertising & Labeling, Forest Laboratories More Info
June 21/ 2013

Clinical Development, Contracts and Outsourcing in MENA & APAC

This webinar will provide an overview of clinical outsourcing in the MENA (Middle East and North Africa) and APAC (Asia-Pacific) regions, and considerations for programs of development.In order to reduce costs and to speed up drug development, large pharmaceutical companies have increased their efforts to outsource clinical activities. Companies are making more R&D investments in Asia’s fast growing markets and are forming alliances and partnerships with global and local CROs to support these efforts.As a consequence, consolidation activity has increased within CROs to meet demand. In light of these changes, it is important for drug development organizations to understand the challenges and motivators that may arise when outsourcing in MENA and APAC. Speaker:

  • Larry Ajuwon, (former)Senior Outsourcing Manager, Genzyme Europe, the Netherlands More Info
June 19/ 2013

Drug Safety & Risk Management

Drug safety has become one of the most challenging public health issues. Patients, physician, health care organizations are all responsible for monitoring the potential side effects caused by drugs.Pharmaceutical companies are making great efforts to ensure the safe use of medication through product labeling, risk management and post-marketing safety surveillance.Speaker:

  • Amy Sun, MD, Ph.D., FACP,Director of Clinical Risk Management,Merck More Info
June 14/ 2013

Adhering to Good Clinical Practice: An Overview of Clinical Trials

Conducting clinical trials is not just treating patients—it is a controlled experiment with regulations to be followed. During the conduct of research involving human subjects, it is critical to adhere to principles of good clinical practice (GCP) and human subject protection (HSP). Good clinical practice is an international scientific and ethical quality standard for the design, conduct, execution, monitoring, auditing, recording, analysis, and reporting of all clinical trials that involve human subjects to ensure: • Protection of rights and safety of human subjects • Consistency with the Declaration of Helsinki • Accuracy and credibility of clinical trial data.Speaker:

  • Jeremy Lim, Pharm.D.,Fellow, Clinical Development, Novartis Pharmaceuticals Corporation More Info
May 31/ 2013

Nanotechnologies in Bioscience

Nanotechnology is an emerging technology with enormous potential in the bioscience industry, including biotechnology, medicine, medical technology, disease treatment and human healthcare.Join Dr. Toby Gill as he discusses the latest developments in nanotechnology. Dr. Jeff Hrkach will then present different approaches to targeted therapeutics such as molecularly targeted drug molecules, nano medicines and antibody-drug conjugates..Speaker:

  • Dr. Toby Gill, Independent Nanotechnology Professional, UK & Dr. Jeff Hrkach, Senior Vice President of Technology, Research and Development, BIND Therapeutics More Info
May 10 / 2013

Evolving Market Access in the APAC Region: The Pharmaceutical Market in China

As the pharmaceutical industry in the West is being challenged with austerity and increasing pricing pressure, companies have started looking to diversify their portfolios through emerging markets. The countries within emerging markets are highly diverse and business models need to be locally tailored to ensure success. This first webinar in the series examines market access related issues in China, including the ongoing healthcare reform in China and its implication on access.Speaker:

  • Chia Wen Lee, Head of Emerging Markets Access, Biogen Idec More Info
April 18 / 2013

Best Practices for Lean Six Sigma in Clinical Development and R&D

Lean and Six Sigma are complementary strategies which offer significant benefits when implemented individually, however when applied together in a cohesive, integrated approach, their synergies yield further improvements in throughput, reproducibility and quality. Over time, Lean Six Sigma will become a seamless and critical operational strategy that will enable lasting change and significant improvements in efficiency and productivity. The speaker examines the move in the pharma/biotech industry to the adoption and implementation of Lean Six Sigma.Speaker:

  • Rodgrio Crispim,Hub Unit Manager,Regional Clinical Operations Office,Bristol-Myers Squibb More Info
April 17 / 2013

Serialization in Pharmaceuticals

Serialization provides many benefits in addition to regulatory compliance, including improving patient safety, protecting corporate reputation, enhancing corporate social responsibility, and providing a competitive advantage. There is also value in data collected through serialization efforts. Manufacturers are discovering different ways to make best use of the data being returned by their supply chain partners. Moreover, counterfeiting of drugs and medical devices costs the pharmaceutical and medical device industry billions of dollars annually in lost revenues. This loss is amplified by the serious threats fake drugs pose to the health and safety of consumers.Our speaker from Bristol-Myers Squibb, one of the first companies to understand the multiple benefits of item level serialization, as he examines serialization and it use in fighting counterfeit drugs.Speaker:

  • Mr. Daljeet Sahni, AD Global Supply Chain, Bristol Myers Squibb More Info
Feb 27 / 2013

Human Research Protection and Understanding the Landscape of AAHRPP Accreditation

Protecting research subjects and ensuring the quality of research remain top priorities for sponsors, IRBs, and investigative sites. AAHRPP accreditation is one way that investigative sites and IRBs can demonstrate to sponsors and the public that they maintain high quality in conducting or reviewing research. AAHRPP accreditation is a transformative process that helps investigative sites and IRBs infuse quality measures and outcomes into all aspects of their operation.Dr. Speers describes the AAHRPP accreditation process, the value of accreditation and why sites and IRBs should seek accreditation, and demonstrate that research protection and quality are responsibilities of those at the highest level at the site.Speaker:

  • Marjorie A. Speers, Ph.D., President and CEO, AAHRPP More Info
Feb 20 / 2013

EU Good Distribution Practice Guidelines 2013

By January 2013 the renewed European GDP Guideline will be published. The existing directive (1994) will be thoroughly overhauled and adapted to the medicines distribution developments of the past 20 years. Major development changes regarding internationalization and globalization will make supply chain in this region more complex and risky.Speaker:

  • Riekert Bruinink, Dutch Health Care Inspectorate, The Netherlands Senior GMP/GDP Inspector More Info
Feb 8 / 2013

How to Ensure Pharmacovigilance Practices are Compliant with Global Safety Requirements: Challenges in Asia-Pacific

Although PV activities such as handling Individual Case Safety Reports (ICSRs), writing Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs) are standard processes managed by pharmaceutical companies, the way such activities are regulated by various Regulators is not always harmonized. Requirements and timelines can vary greatly amongst Regulators and are not always consistent with International Standards. As a result pharmaceutical companies need to ensure they comply with the various requirements and timelines from international Regulators. This webinar will focus on ensuring compliance with international and local country specific PV Requirements from an Asia-Pacific perspective.Speaker:

  • Michal Borawski, International Pharmacovigilance Officer for the Asia-Pacific Region, Sanofi Pasteur More Info
January 30 / 2013

Biosimilar Regulatory Guidelines in Emerging Markets-India

For companies embarking on a biosimilar drug development program, the goal is clear, but the road to get there is less so. If you can scientifically demonstrate that a biologic product is highly similar to the approved biologic, you’ll be able to abbreviate and reduce the burden of preclinical and clinical trials data package as part of submission for market authorization. The Indian Government has developed and issued guidelines which apply to similar biologics that contain well characterized proteins as their active substance, derived through modern biotechnological methods such as the use of recombinant DNA technology.Speaker:

  • Vijay Tammara,VP Global Regulatory Affairs, Nuron Biotech,AAPS Member More Info
January 24 / 2013

New FDA Guidelines on Biosimilars and Biobetters:An outlook 2013

The development of biosimilars have garnered great interest for their cost-effective benefits in patient care as well as developmental opportunities for industry sponsors who see a new revenue stream. However, the pathway to commercialization is complicated by regulatory challenges. There is still a need to understand the expected requirements for biosimilars registration, as well as focused data requirements to establish a viable, safe and effective product.Speaker:

  • Dr. Steven Engel, MS, PharmD, Senior Principal Scientist, Worldwide Regulatory Affairs, Merck & Co., Inc. More Info
January 16 / 2013

Temperature Controlled Distribution and Risk management

Cold chain logistics is currently one of the biggest growth areas in the pharmaceutical industry, particularly for companies operating in emerging markets such as Russia and the Commonwealth of Independent States (CIS). The process will allow companies to cut costs and reduce waste through their supply chain but at the same time there is a need to maintain compliance with regulations specific to this region. The safe handling of vaccines as well as other temperature sensitive products and materials has given rise to a need for stronger vigilance with regards to the integrity of cool chain in the region. Transgressions not only result in regulatory non-compliance issues but also cost dearly in terms of meeting supply deadlines and product wastage.Speaker:

  • Elena Adusei ,Director, Customer & Logistics Services, Russia & CIS cluster, J&J enterprise (MD&D, Janssen Consumer), APCIS Member More Info
December 5 / 2012

QbD for Generics: Opportunities and Challenges

Expectations for the generic industry have been mandated by the Office of Generic Drugs (OGD) over recent years at various meetings, workshops and roundtables. While developing high quality and robust products and processes, it is also essential to stay effective and efficient. Therefore, it is critical that we utilize and manage our expertise in the most effective way.Speaker:

  • Inna Ben-Anat, QbD Strategy Leader, Teva Pharmaceuticals More Info
November 13 / 2012

Risk-Based Monitoring in Clinical Investigations

In the absence of clear rules and guidelines from the FDA and EMA, companies are left trying to determine exactly what an effective and compliant risk-based monitoring program should look like.This webinar will not only leave you with a clearer understanding -from a Big Pharma company- on how to establish such a program, but can also provide ways in which you will be able to fine-tune your existing program.Speaker:

  • Stanley E. Reaves Jr., RCIS, CCRP, Senior Clinical Research Associate, Abbott Vascular More Info
October 29 / 2012

Discussing the Sunshine Act

While no one will argue that transparency in an industry is a bad thing, many will be faced with the challenges that come with such a far-reaching legislation. Full implementation of this legislation is on the way. Before you know it, March 23, 2013 the date of implementation, will be here.Speaker:

  • Konstantinos Papandrikos, Director, Transparency Operations, US Medical Affairs, SANOFI US More Info
October 23 / 2012