Workshops

Join us for a preconference warm up. Stretch your learning potential during our one-day and two-day workshops. Each is designed as an opportunity for you to take an extensive, in-depth look into specific regulatory topics, organized by experts. Prepare to fully explore an area of interest and emerge with an advanced skillset and newly developed strategies.

Single-day workshops can be mixed and matched based on your preference to focus on a specific product area or region. Two-day workshops span Monday and Tuesday to allow in-depth coverage of specific topics or regions. They cannot be combined with the single-day workshop offerings.

1 OctoberMonday, 1 October

9:00 am–5:00 pm
US Regulatory Essentials, Medical Devices and IVDs

A comprehensive overview of US regulatory affairs for devices and IVDs, this workshop will benefit individuals who are new to the regulatory profession, changing product line or industry or preparing for the RAC (US) examination. Laws and policies affecting US regulation of devices and IVDs; an overview of the agency structures regulating these products; advertising, labeling and promotional aspects; and post-market, compliance and enforcement requirements will be covered.
Agenda

EU Regulatory Essentials, Pharmaceuticals and Biologics

A comprehensive overview of EU regulatory affairs for pharmaceuticals and biologics, this workshop will benefit individuals who are new to the regulatory profession, changing product line or industry or preparing for the RAC (EU) examination. Regulations, directives and policies affecting Europe’s regulatory system with specific issues and information addressing development considerations, clinical trials, marketing applications, pre- and post-marketing requirements will be covered.
Agenda

Demystifying the EU MDR and IVDR: From Transition to Implementation (Basic to Intermediate)

Transition continues for medical devices and IVDs from the current European directives to new European regulations. The Active Implantable Medical Device Directive (AIMDD) and Medical Devices Directive (MDD) will be transformed into the new Medical Device Regulation (MDR). For IVDs, the In Vitro Diagnostic Directive (IVDD) will be replaced by the In Vitro Diagnostic Regulation (IVDR). This workshop will divide into two tracks. Each track will reconfirm the essentials of the current directives, address the changes introduced by the regulations and provide input for planning a successful transition process. Experts will provide attendees with a solid understanding of what remains the same, what changes and the new requirements that must be addressed.
Agenda

Optimizing Your Strategy: Expedited Pathways and More!

This workshop will examine the opportunities and incentives available to sponsors in the development and approval of drugs and biologics in ICH regions and emerging markets. The workshop will include a “toolkit” of what’s available, how to overcome challenges in strategic decision making, and insight in finding and analyzing FDA precedent and applying to case studies.
Agenda

Pricing

By 31 May 2018
RAPS Member: $525
Nonmember: $685

By 31 August 2018
RAPS Member: $575
Nonmember: $750

After 31 August 2018
RAPS Member: $625
Nonmember: $815

Toolkit for the Emerging Regulatory Leader

New to leadership? Moving into leadership requires us to shift our thinking and approach to our work. It is the shift from technical expert to strategic facilitator. This fast-paced, interactive one day workshop is designed to build both people and productivity leadership skills. We will begin with foundational communication and people leadership tools you can take back and implement immediately: meeting best practices, the art of giving and receiving feedback, and tips for motivating and engaging employees. Next we turn to prioritization and time design tactics to ensure that you are managing and investing your time wisely. Finally, industry leaders will share their experiences, and provide the dos and don’ts for managing challenging situations in the workplace.
Agenda

2 OctoberTuesday, 2 October

8:00 am–4:00 pm
US Regulatory Essentials, Pharmaceuticals and Biologics

A comprehensive overview of US regulatory affairs for biologics and pharmaceuticals, this workshop will benefit individuals who are new to the regulatory profession, changing product line or industry or preparing for the RAC (US) examination. Laws and policies affecting US regulation of biologics and pharmaceutical products; an overview of the agency structures regulating these products; advertising, labeling and promotional aspects; and postmarket, compliance and enforcement requirements will be covered.
Agenda

Demystifying the EU MDR and IVDR: From Transition to Implementation (Intermediate to Advanced)

Transition continues for medical devices and IVDs from the current European directives to new European regulations. The Active Implantable Medical Device Directive (AIMDD) and Medical Devices Directive (MDD) will be transformed into the new Medical Device Regulation (MDR). For IVDs, the In Vitro Diagnostic Directive (IVDD) will be replaced by the In Vitro Diagnostic Regulation (IVDR). This workshop will divide into two tracks. Each track will reconfirm the essentials of the current directives, address the changes introduced by the regulations and provide input for planning a successful transition process. Experts will provide attendees with a solid understanding of what remains the same, what changes and the new requirements that must be addressed.
Agenda

Toolkit for the Emerging Regulatory Leader

New to leadership? Moving into leadership requires us to shift our thinking and approach to our work. It is the shift from technical expert to strategic facilitator. This fast-paced, interactive one day workshop is designed to build both people and productivity leadership skills. We will begin with foundational communication and people leadership tools you can take back and implement immediately: meeting best practices, the art of giving and receiving feedback, and tips for motivating and engaging employees. Next we turn to prioritization and time design tactics to ensure that you are managing and investing your time wisely. Finally, industry leaders will share their experiences, and provide the dos and don’ts for managing challenging situations in the workplace.
Agenda

Regulatory Intelligence as a Strategic Imperative

This interactive workshop will examine the fundamentals of regulatory intelligence, including what it is and isn’t, how it is conducted, the strategic value it brings to key partners and how it is an imperative to regulatory decision making throughout a development program and lifecycle management of a therapeutic product. Discussion and hands-on exercises will provide insights on the collection, analysis, communication and management of regulatory intelligence. The workshop will cover prescription drugs and biologics with a focus on the United States.
Agenda

Pricing

By 31 May 2018
RAPS Member: $525
Nonmember: $685

By 31 August 2018
RAPS Member: $575
Nonmember: $750

After 31 August 2018
RAPS Member: $625
Nonmember: $815

Two-Day Workshops

Monday 1 October 9:00 am–5:00 pm
Tuesday 2 October 8:00 am–4:00 pm
Regulatory Strategy for the Biologics Regulatory Professional

Knowing how to develop an effective global regulatory strategy is an essential skill for regulatory professionals. In this two-day strategy workshop, experts will take you on a guided tour through the process of developing regulatory strategy for biologic products, including monoclonal antibodies, biosimilars, and cell and gene therapies. You will work in teams and learn how to maximize regulatory success for these biologic products.
Day 1 Agenda Day 2 Agenda

Developing Your Global Medical Device Regulatory Strategy

Knowing how to develop an effective global regulatory strategy is an essential skill for regulatory professionals. In this two-day strategic workshop, experts will take you on a guided tour through the process of developing regulatory strategy. You will work in teams and learn how to maximize commercial opportunities for healthcare product manufacturers while minimizing company risk.
Day 1 Agenda Day 2 Agenda

Pricing

By 31 May 2018
RAPS Member: $1,050
Nonmember: $1,370

By 31 August 2018
RAPS Member: $1,150
Nonmember: $1,500

After 31 August 2018
RAPS Member: $1,250
Nonmember: $1,630

Advanced Leadership Workshop

Monday 1 October 9:00 am–5:00 pm
Tuesday 2 October 8:00 am–4:00 pm
Advanced Leadership Workshop

Take the next step in your career with expert-led leadership training with 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.
Day 1 Agenda Day 2 Agenda

Pricing

By 31 May 2018
RAPS Member: $2,895
Nonmember: $3,765

By 31 August 2018
RAPS Member: $2,945
Nonmember: $3,830

After 31 August 2018
RAPS Member: $2,995
Nonmember: $3,895