All Conferences

DigiMarCon Africa 2018 is your chance to ... - Hear from the most audacious and provocative speakers in the digital marketing industry. - Gain insight into emerging strategies, the latest innovative technologies, and best practices. - Network with thought leaders, build your network and collaborate with your peers. DigiMarCon Africa 2018 Digital Marketing Conference will be held from November 8th to 9th, 2018 at the luxurious Hyatt Regency in Johannesburg, South Africa. Whether your goal is to reinforce customer loyalty, improve lead generation, increase sales, or drive stronger consumer engagement, the DigiMarCon Africa 2018 program has been specifically designed to…

Course "Industrial Technical Trainer Certification" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Each training day consists of eight full hours of instruction and skill practice. Trainee trainers must demonstrate competence at the end of the seminar by developing and preparing a simple training session utilizing all of the skills mastered. Trainees are evaluated and certified as technical trainers at the completion of the program when all performance measures have been met. Day one of the workshop will build the foundation for effective adult learning particularly in…

Course "Statistical Sampling Plans - Methods and Applications" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Acceptance sampling plans are important tools for manufacturers. Effectively used they can help reduce costs while assuring quality and controlling risks. Unfortunately, this rich field of techniques is not as prominent as it once had been. As a result, quality practitioners don't always appreciate the wide range of available options or understand how to choose among alternate statistical sampling plans. Because there are no published standards or guides to help select…

Course "Managing Your FDA Inspection: Before, During and After" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: FDA's inspection program follows well-established procedures and conducts the inspections with as much consistency as possible. FDA trains its investigators from day one. During the first six months, they attend extensive classroom and hands on training. FDA investigators learn basic skills. As time goes on, special training is given and the field staff use detailed reference materials to guide their thinking, actions, decisions and conclusions. If you understand FDA's management…

Overview: Organizations of all types and sizes continue to struggle needlessly with HIPAA Compliance. For example, HIPAA Risk Analysis - Risk Management is the basis of the HIPAA Compliance Program of every Covered Entity and Business Associate. But mandatory HIPAA Compliance Audits conducted by the Office for Civil Rights (OCR), the HIPAA enforcement arm of the U. S. Department of Health and Human Services (HHS), found 94% of Covered Entities failed the Risk Management Audit and 87% failed the Risk Analysis Audit. And every audited Covered Entity knew well in advance that it was on the short list to be…

Course "Preparing the Marketing Authorization Application in the EU, with a focus on the product information" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: In this seminar, we will look into all elements of the MAA dossier, in particular module 1, and within this module the Product Information. In addition, the various meetings with the Health Authorities in the centralized procedure will be discussed. Regular review and monitoring of product information for medicines is important, to support awareness of relevant updates/changes which may affect prescribing, dispensing, administration…

Course "Good Clinical Data Management Practices (GCDMP)" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Why should you attend: Good clinical data management (CDM) is paramount for a successful research. After all, Garbage In, Garbage Out (GIGO). CDM is involved in all aspects of collecting, processing, and interpreting information. There are many types of computer applications and database systems to support data collection and management. However, there are elements of Good Clinical Practice that apply across the board. Review and approval of drugs or devices by regulatory…

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…

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…

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…

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…

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…

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…

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…

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…

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…

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.

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

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…

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…