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The Use of Drug Master Files & Quality Agreements: Understanding and Meeting your Regulatory and Processing Responsibilities

The Use of Drug Master Files & Quality Agreements: Understanding and Meeting your Regulatory and Processing Responsibilities

Location: , United States
Category: Education
Start Date: 04-12-2018 Last Day: 04-13-2018 Deadline for abstracts: 04-10-2018
Course "The Use of Drug Master Files & Quality Agreements: Understanding and Meeting your Regulatory and Processing Responsibilities" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This combined DMF (Drug Master Files) and Quality Agreement training will discuss the advantages for suppliers and drug product manufacturers in developing these arrangements together. Over time, there have been several misunderstandings between supplier / contractors and pharmaceutical / biologic finished product manufacturers. The root of many of the problems lie in a lack of a suitable agreement delineating roles, responsibilities…
eCTD Submissions of IND/NDA to the US FDA, EU and Canada 2018

eCTD Submissions of IND/NDA to the US FDA, EU and Canada 2018

Location: , United States
Category: Health and Medicine
Start Date: 04-05-2018 Last Day: 04-06-2018 Deadline for abstracts: 04-03-2018
Course "eCTD Submissions of IND/NDA to the US FDA, EU and Canada" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: The international agreement to assemble all Quality, Safety and Efficacy information for a drug or biologic product into a common format (called the CTD - Common Technical Document) has improved the speed and efficiency for companies working in global development programs and clarified expectations by regulatory bodies. Reformatting for multiple submissions is substantially limited. The CTD has improved the regulatory review processes and enabled implementation of good…
A Risk Based Strategy for the Development & Validation of and Validation of Analytical Methods with a QbD Approach

A Risk Based Strategy for the Development & Validation of and Validation of Analytical Methods with a QbD Approach

Location: , United States
Category: Education
Start Date: 04-05-2018 Last Day: 04-06-2018 Deadline for abstracts: 04-03-2018
Course "A Risk Based Strategy for the Development & Validation of and Validation of Analytical Methods with a QbD Approach" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Following the initial development, the steps further continues thru optimization and subsequently to Validation, leading to the understanding of Validation Parameters and their generic definitions. Guidance from EP, USP, ICH Q2 (R)1, AOAC etc. will be discussed. The presentation continually builds on from a conceptual level to practical applications leading to data handling, Data Integrity, Validation Protocol and other…
Evolution of the Quality Management System - How to go from Surviving to Thriving 2018

Evolution of the Quality Management System - How to go from Surviving to Thriving 2018

Location: , United States
Category: Health and Medicine
Start Date: 04-05-2018 Last Day: 04-06-2018 Deadline for abstracts: 04-04-2018
Course "Evolution of the Quality Management System - How to go from Surviving to Thriving" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Using lecture, discussion, and exercises, this 2 day seminar will focus on taking your QMS from surviving to thriving. We'll move from understanding the regulatory requirements, how to create your QMS structure, process thinking, and developing your improvement strategy. We'll discuss tools and techniques for improvement and how to measure your progress. Why you should attend: Many companies struggle to establish and maintain a…
HIPAA Training for the Compliance Officer 2018

HIPAA Training for the Compliance Officer 2018

Location: , United States
Category: Education
Start Date: 04-02-2018 Last Day: 04-03-2018 Deadline for abstracts: 04-02-2018
Overview: This lesson will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order as HIPAA is now fully enforced and the government is not using kid gloves any more. It will also address major changes under the Omnibus Rule and any other applicable updates for 2018 and beyond. There are an enormous amount of issues and risks for covered entities and business associates these days. I will speak on specific experiences from over 17 years of experience in working as an outsourced compliance auditor, expert witness on multiple HIPAA cases, and thoroughly explain…
Deriving Value from Operational Risk Modelling

Deriving Value from Operational Risk Modelling

Location: , United Kingdom
Category: Business and Economics
Start Date: 02-28-2018 Last Day: 03-01-2018
Day one will commence with an overview of op risk and the regulatory scope. The BCBS intentions and proposals through their SMA will be explained and comprehensively covered, moving on to an explanation of sources of new data and how best to prepare these and ensure your strategies will hold up. Following this, a substantial scenario analysis overview, going through the steps and how to mitigate unconscious behavioural biases. Day two continues with methods for dealing with operational loss data, moving on to stress testing in operational risk modelling and how to develop the best possible methodologies and ensure consistency…
Effective Listening: Key Skills for Managers and HR Professionals

Effective Listening: Key Skills for Managers and HR Professionals

Location: , United States
Category: Business and Economics
Start Date: 03-15-2018 Last Day: 03-15-2018 Deadline for abstracts: 03-15-2018
OVERVIEW Listening skills are critical for success in any management or HR job, as well as for any employees who want to be viewed as effective leaders in the workplace. Managers typically spend more time listening than any other workplace behavior, and the same is true for HR professionals. Why is listening so important for managers and HR practitioners? Simply put, because employees want, expect and need to be heard. Regardless of how well you perform the other aspects of your supervisory or HR position, employees aren’t likely to see you as effective if they don't believe that you really…
Trade Surveillance for Energy Trading Firms

Trade Surveillance for Energy Trading Firms

Location: , United Kingdom
Category: Engineering and Technology
Start Date: 03-15-2018 Last Day: 03-16-2018
Day 1 will discuss the different needs and approaches for companies regarding their trade surveillance as there is no one-size-fits-all approach. Discussion will cover how trade surveillance is evolving, having the right systems, physical withholding and patterns. Other sessions will revolve around optimising your systems and operational efficiency as a tool for business insight. The second day will begin by considering the effects regulation has had on the compliance function. This will be followed by a session on data quality and management to examine the right information is being collected. Following on from lunch, we will discuss behavioural analysis and…
ALM and Balance Sheet Optimisation

ALM and Balance Sheet Optimisation

Location: , United Kingdom
Category: Business and Economics
Start Date: 03-21-2018 Last Day: 03-22-2018 Deadline for abstracts: 03-21-2018
Risk Training's two day training course returns to London to help attendees understand the three main challenges within ALM; liquidity, interest rate risk and capital. Day one of the course will delve into the evolution of the ALM function in the context of a changing regulatory environment, along with discussing ILAAP, liquidity under Pillar II. The day ends with a session on behavioural modelling and interest rate risk, focusing on IRR metrics & scenarios and value measures. Day two will continue with a comprehensive overview of balance sheet management and optimisation strategies, moving on to an explanation of how to…
Nineteenth International Conference on Diversity in Organizations, Communities & Nations - University of Patras

Nineteenth International Conference on Diversity in Organizations, Communities & Nations - University of Patras

Location: , Greece
Category: Social Sciences and Humanities
Start Date: 06-05-2019 Last Day: 06-07-2019 Deadline for abstracts: 05-05-2019
Diversity in Organizations, Communities & Nations Research Network: a conference and a journal collection founded in 2000, sharing perspectives on diversity and exploring the forms and futures of human difference and diversity.
Nineteenth International Conference on Diversity in Organizations, Communities & Nations - University of Patras

Nineteenth International Conference on Diversity in Organizations, Communities & Nations - University of Patras

Location: , Greece
Category: Social Sciences and Humanities
Start Date: 06-05-2019 Last Day: 06-07-2019 Deadline for abstracts: 05-05-2019
Diversity in Organizations, Communities & Nations Research Network: a conference and a journal collection founded in 2000, sharing perspectives on diversity and exploring the forms and futures of human difference and diversity.
Adjoint Algorithmic Differentiation (AAD) Masterclass

Adjoint Algorithmic Differentiation (AAD) Masterclass

Location: , United Kingdom
Category: Business and Economics
Start Date: 03-21-2018 Last Day: 03-22-2018
In this two-day course, attendees discuss the mathematical foundations for adjoints methods, algorithmic differentiation (AD) as a general computational technique for the efficient calculation of price sensitivities, and the use of AD software as a way to generate the adjoint code. Focus will be placed on its application to Monte Carlo methods for SDEs and finite difference methods for PDEs. Time: 09:00 to 17:00 Price: Standard Pricing: GBP 1999
2018 Off-Label Regulatory Compliance Congress

2018 Off-Label Regulatory Compliance Congress

Location: , United States
Category: Health and Medicine
Start Date: 05-21-2018 Last Day: 05-22-2018
As the demand for information outside of approved labeling continues to rise, the FDA has been called by the industry to provide guidance that governs off-label communications. The regulatory landscape that monitors this space is often blamed for limiting the amount of information received by patients and restricting their ability to make well-informed decisions. Given the public health issues at stake and the public interest involved, it is imperative that this event details the importance of the timely communication of truthful scientific information that currently challenges pharmaceutical, biotech, and medical device professionals. The 2018 Off-Label Regulatory Compliance Congress also explores…
Trade Surveillance and Market Compliance for Energy Trading Organizations

Trade Surveillance and Market Compliance for Energy Trading Organizations

Location: , United States
Category: Business and Economics
Start Date: 02-21-2018 Last Day: 02-22-2018 Deadline for abstracts: 02-21-2018
In this Risk Training event, following incredible feedback for our highly successful event last October, day one will look at the current state of trade surveillance and market compliance. Attendees will discuss what trade surveillance is and the tools of the trade before hearing a case study on trade surveillance integration. Day two will focus on the models and technology that will ensure your system works for your needs as there is no one-size-fits-all approach. Sessions will include a talk on data quality and management to examine the right information is being collected. Operational efficiency, business insight and optimizing your…
34th Annual Echo in Pediatric and Adult Congenital Heart Disease

34th Annual Echo in Pediatric and Adult Congenital Heart Disease

Location: , United States
Category: Health and Medicine
Start Date: 10-05-2018 Last Day: 10-07-2018
This three-day symposium is designed to provide a comprehensive understanding of the anatomy, clinical aspects, imaging, and management of patients with congenital heart disease. The symposium will include case discussions, didactic seminars, anatomic and imaging correlations, discussion of multimodal imaging and live, hands-on scanning seminars to illustrate the impact of cardiac imaging on treatment, diagnosis, and management of patients with congenital heart disease. URL: Booking: https://go.evvnt.com/197352-1?pid=154 Prices: MD, PhD, DO, PharmD: USD 755 Residents, Sonographers, RN: USD 620 LATE FEE-MD, PhD, DO, PharmD: USD 855 LATE FEE-Residents, Sonographers, RN: USD 720 Time: 7:30 am to 11:45 am
IFRS 17: Managing Insurance Contracts

IFRS 17: Managing Insurance Contracts

Location: , United Kingdom
Category: Business and Economics
Start Date: 02-28-2018 Last Day: 03-01-2018
In 2017, the International Accounting Standards Board (IASB) introduced IFRS 17, presenting a major change for the insurance industry, which could potentially have a more dramatic impact that Solvency II. Though implementation is not required until 2021, it is important for the industry to get to grips with that the new standards will require and begin considering their implementation strategies. Risk Training's two day course will provide an overview of the standards, discuss the measurement models, key business challenges presented, how to confront IFRS 17 within your business and will suggest strategies for working towards implementation. Price Standard Pricing: GBP…
5th NovAliX Conference - Biophysics in Drug Discovery 2018

5th NovAliX Conference - Biophysics in Drug Discovery 2018

Location: , United States
Category: Health and Medicine
Start Date: 06-13-2018 Last Day: 06-15-2018
The use of biophysical methods has become pervasive in the drug discovery process, allowing not only to identify low-affinity hits at the screening stage but also to obtain detailed information on target / ligand interactions at more advanced stages (see the review Renaud et al. 2016 Nat. Rev. Drug Discov. 15: 679-698). This is perfectly illustrated by the success of FBDD (fragment-based drug design), where the progress of biophysical techniques in terms of sensitivity, speed, and automation has been instrumental (see the review Erlanson et al. 2016 Nat. Rev. Drug Discov. 15: 605-619). Indeed FBDD is now widely adopted in…
Digital Health and Digital Technologies Congress

Digital Health and Digital Technologies Congress

Location: , United Kingdom
Category: Computer Science and Internet
Start Date: 09-25-2018 Last Day: 09-26-2018
Join Oxford Global for the Digital Health and Digital Technologies Congress, 25-26 September 2018, London where over 250 attendees will be representing global pharmaceutical organisations, leading biotech companies and internationally renowned academic institutions. Across two days, we will bring together 18 presentations and case studies focusing on the key developments in digital health and digital therapeutics looking at critical areas such as digital health regulations, patient engagement, wearable technologies, digital therapeutic technologies and optimising real-time technology in clinical trials. Including 2 interactive streams: • Digital Health Strategies • Designing and Developing Digital Therapies View Agenda: http://bit.ly/2E9DeOX For further information regarding…
2nd Annual Artificial Intelligence in Drug Development Congress

2nd Annual Artificial Intelligence in Drug Development Congress

Location: , United Kingdom
Category: Health and Medicine
Start Date: 09-25-2018 Last Day: 09-26-2018
Join Oxford Global for the 2nd Annual Artificial Intelligence in Drug Development Congress, 25-26 September 2018, London where over 250 artificial intelligence and pharmaceutical IT attendees with represent leading biotech companies, global pharmaceutical organisations and internationally renowned academic institutions. Across two days, we will bring together 30 presentations and case studies focussed on the innovatice application of artificial intelligence in drug discovery and discovery chemistry, alongside machine learning in clinical trials and cloud computing. Including 3 interactive streams: • AI in Drug Discovery and Discovery Chemistry • Machine Learning and Personalising Patient Treatments • AI in Big Data and Clinical…
Downstream 2018 Conference and Exhibition

Downstream 2018 Conference and Exhibition

Location: , United States
Category: Education
Start Date: 05-31-2018 Last Day: 06-01-2018 Deadline for abstracts: 05-31-2018
The Downstream Conference and Exhibition is positioned at the forefront of the booming Downstream industry in North America. This industry leading event is regarded as the most significant meeting place for Downstream Capital Project, Engineering, Maintenance, Reliability and Turnaround professionals, where they meet to do business. The Downstream convention has fast become a next generation energy event, hosting major Integrated and independent Downstream energy companies, global EPC contractors, technology providers, and service companies all of whom play an active role in the global Downstream industry. The Downstream 2018 conference will see more global business leader dialogue sessions and strategic panel…

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