Workshops

Demystifying the EU MDR: From Transition to Implementation

From 26 May 2020, any publication of a notification with respect to a Notified Body in accordance with the current directives 90/385/EEC (Active implantable medical devices) and 93/42/EEC (medical devices) will become void. From 26 May 2022, any publication of a notification in respect of a Notified Body in accordance with Directive 98/79/EC will become void. All Notified Bodies (NBs) acting in Europe at this moment of time need to apply for the new regulation(s) depending on their scope of interest and their available competence ensuring business and service continuity. This process is described in both the regulation(s) and more detailed in the NBOG document but is not as smooth as everyone expected, leading to limited time for both NBs and manufacturers.

Pediatric Drug Development Regulatory Strategies for Global Success

For drugs in development, sponsors must consider the use or potential use of the drug in a pediatric population. Successful pediatric regulatory strategies can be complex. Lack of harmonization in regulatory requirements and challenges in developing a robust pediatric global strategy can result in not only a delay in approval adversely impacting patients but also increased costs. Although there are many similarities, differences exist and knowing these differences is critical to developing a successful regulatory strategy. The workshop will explain the US, EU, and Japan pediatric drug development requirements and address key challenges in an evolving regulatory landscape. This workshop will engage participants through mock development of pediatric strategies, identifying regulatory risks and approaches to mitigate those risks. The workshop also will discuss the need for alliances with patient representatives and patient advocacy groups.

Toolkit for the Emerging Regulatory Leader

As regulatory professionals develop in their roles, responsibilities begin to change. Navigating the shift from technical expert to strategic facilitator is an important career turning point. Often these emerging leaders are asked to lead projects without the privilege of position. This level of responsibility requires a new leader to shift from task-centered compliance to people-focused influence. Now they are managing multiple priorities and interfacing with a variety of colleagues who also have different urgencies. This course addresses the critical communication, influence and delegation skills needed to successfully lead projects and teams to their desired outcomes.

Moving Beyond IVDR Requirements to Fulfillment

How do you move beyond knowing what the IVDR requirements are and how to fulfill them? Many new concepts apply. Since 90% or more of IVDs currently on the EU market have not been scrutinized by a Notified Body, this is a new experience in conformity assessment. Many manufacturers have a broad offering of devices requiring submission and it is crucial for attending regulatory professionals to gain working knowledge of the IVDR to not lose time learning the ropes and be able to present a submission that demonstrates full conformity in a shorter timeframe.

Key Elements to Consider in the Technical Documentation of Drug-Devices Combination Products for Europe

For medical devices incorporating a medicinal substance, the process of review of their technical documentation under the European Directives takes significantly more time than for other devices due to their high risk. These products being innovative, helping the industry to identify and address the main pitfalls, would enhance a safer and potentially faster access to the market. Medical devices incorporating a medicinal substance are among the most complex categories. Due to their high risk and their particular aspects, the process of their pre-market approval review requires significant resources, health actors’ cooperation and time by regulators. Several factors could impact the outcome of the review and delay the processing of those files due to incomplete files, information not clearly indicated, differences with the format expected by the Competent Authority and/or the Notified Body, etc. This workshop aims to highlight the main pitfalls in avoiding submitting a CE application for this kind of product, and other main elements which could influence the process of review. In the context of MDR, this session will also present some new changes brought by this regulation impacting those products (Article 117 etc.).

Pricing

By 28 June 2019
RAPS Member: $610
Nonmember: $795

After 28 June 2019
RAPS Member: $660
Nonmember: $860

EU MDR Annex II Technical Documentation Details: Too Much? Too Little? What is Just Right?

As the final year of the EU MDR transition commences, manufacturers are actively updating their existing device technical documentation. It is understood that the expectation is for the detail of the summary documentation to be greater than has been previously expected, but how much detail is enough? Manufacturers find themselves in a conundrum when choosing between explicit detail in the summary technical documentation (potentially hastening review and approval by the Notified Body) vs. driving resource efficiencies in maintenance of the information and global submission strategies. In this workshop we will dive into answer the question, “How much detail is sufficient?”

Toolkit for the Emerging Regulatory Leader

As regulatory professionals develop in their roles, responsibilities begin to change. Navigating the shift from technical expert to strategic facilitator is an important career turning point. Often these emerging leaders are asked to lead projects without the privilege of position. This level of responsibility requires a new leader to shift from task-centered compliance to people-focused influence. Now they are managing multiple priorities and interfacing with a variety of colleagues who also have different urgencies. This course addresses the critical communication, influence and delegation skills needed to successfully lead projects and teams to their desired outcomes.

Integrating Human Factors into Your Next Regulatory Submission: Lemons or Lemonade?

Often regulatory professionals are responsible for ensuring all human factor requirements for regulatory submissions are met, even though they may be unfamiliar with the subject. With increasing complexity in the global regulatory landscape and related human factor requirements, regulatory professionals need specific knowledge about human factors to prevent this key requirement from derailing regulatory submissions or causing unnecessary post-submission delays, such as additional studies or other regulatory requirements. This workshop is for the regulatory professional who wants to successfully navigate crucial aspects of human factors and prevent obstacles and risks to your submissions.

Drug Development in EU: Regulatory Standards, Support and New Approaches

Pharmaceutical companies intending to develop and register drugs for the European market need to be aware that the regulatory network in the EU has its own requirements and characteristics which differ in a number of aspects from FDA. Knowledge of the general and distinctive features of the centralized regulatory system in the EU, as coordinated by EMA, with special focus also given on novel regulatory approaches, will benefit successful development and approval of drugs in Europe. Drug development is a multi-step approach that involves a number of opportunities and requirements for interaction with regulatory authorities, spanning from the design and approval of clinical trials, use of scientific advice and other support programs during development, definition of potential orphan status, and pediatric development to specific aspects of advanced therapy products and ways of approval and post-marketing activities/commitments. This workshop will address the various regulatory steps and explain the role of the European regulator not only as being a gate-keeper but also an enabler supporting successful development. Established and new approaches, as provided by the European regulatory network, will be presented and discussed on the basis of anonymized examples and on discussion of practical cases/questions contributed by workshop attendees.

Pricing

By 28 June 2019
RAPS Member: $610
Nonmember: $795

After 28 June 201
RAPS Member: $660
Nonmember: $860

Developing Your Global Medical Device Regulatory Strategy

Putting together a global regulatory strategy can be very challenging for Regulatory Affairs Professionals. Knowing how to develop an effective global regulatory strategy is an essential skill for regulatory professionals. This two-day strategic workshop provides a rich panel of experts that are committed to making sure students learn the process of developing a solid global regulatory strategy for medical device.

Advanced Leadership Workshop

Take the next step in your career with expert-led leadership training from the Regulatory Leadership Institute. Facilitated by professional executive trainers, the Regulatory Leadership Institute immerses you in two fast-paced days of the skills you need to advance your career or step into a leadership role well equipped and attuned to the challenges ahead.
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Pricing

By 28 June 2019
RAPS Member: $2,945
Nonmember: $3,830

After 28 June 201
RAPS Member: $2,995
Nonmember: $3,895

Regulatory Intelligence Strategies for Biopharmaceutical Development

This masterclass lays the foundation for skills crucial for developing robust regulatory intelligence that adds value to the research and development program at every level. This highly interactive class will provide an overview of the fundamentals of global regulatory intelligence including what it is ,explore value building applications during the drug development process and beyond. Regulatory intelligence aids strategy development, provides solutions to overcoming roadblocks, helps filling knowledge gaps, spots trends and provides potential competitive advantages amongst other objectives to add value to a product, program and/or company. During the workshop, discussions, hands-on exercises and polls will provide opportunities to learn and apply effective methods for collection, monitoring, impact assessment and communication of regulatory intelligence within the team, the management chain, the company and outside stakeholders. Effective regulatory intelligence communication also becomes imperative to positively shape the regulatory environment. During the workshop, participants will apply learned skills and techniques in case studies to develop global regulatory strategies, precedents, competitive analysis and communication in biopharmaceutical drug development.

Pricing (non-Leadership workshops)

By 28 June 2019
RAPS Member: $1,220
Nonmember: $1,590

After 28 June 201
RAPS Member: $1,320
Nonmember: $1,720