Live and On-Demand Events

FDA Forecast: What’s next in 2025

December 10, 2024 | 12:00 PM

Alexander Gaffney, Laura DiAngelo

What will the FDA do in 2025, and how could the incoming Trump administration radically alter the agency’s plans? In this timely, lively and informative event, regulatory experts from POLITICO’s AgencyIQ will explain what regulatory professionals should anticipate in the year ahead based on emerging trends, political updates, known issues, regulations, guidance documents and more.

What the 2024 Election Means for FDA and the Industries it Regulates

November 13, 2024 | AVAILABLE ON-DEMAND

Alexander Gaffney, Laura DiAngelo

From the White House to White Oak, the 2024 Presidential and Congressional elections will have significant impacts on the FDA, its policy agenda and its approach to regulation.

After the election, join AgencyIQ for an in-depth, lively, and detailed expert discussion focused on how the election will affect both the FDA and the industries it regulates. Attendees will benefit from actionable insights they can use to plan ahead.

AgencyIQ by POLITICO is a RAPS RAC Approved Provider. This education program meets the RAPS RAC recertification requirements to maintain the RAC credential. For more information about the RAC credential or the Approved Provider program, please visit www.raps.org.

Guidance Roundup: FDA’s end-of-year push on clinical trial policy

October 22, 2024 | AVAILABLE ON-DEMAND

Alexander Gaffney, Laura DiAngelo

In closing out the federal fiscal year, the FDA has released a bevy of new guidance documents related to clinical trials. Altogether, the documents provide a look into how the FDA – and industry – are grappling with new research methods and technologies, and how regulators see interpretation of the existing regulatory paradigms into these new contexts.

At this webinar, AgencyIQ walked through the new documents, focusing on the intersection of the policies with other high-priority developments out of FDA – including real-world data (RWD), digital health technologies (DHTs), new trial designs, and the agency’s work on Diversity Action Plans (DAPs).

AgencyIQ attending RAPS Convergence 2024

September 17, 2024 | INDUSTRY EVENT

Alexander Gaffney, Corey Jaseph, Amanda Conti, Joshua Sztorc, Rachel Gartlan

The AgencyIQ Team will be attending RAPS Convergence 2024, at Long Beach Convention & Entertainment Center, in Long Beach, CA. The annual event, hosted by Regulatory Affairs Professionals Society (RAPS), is the largest gathering of global regulatory affairs professionals. The AgencyIQ Team will be attending sessions as well exhibiting at booth #708.

RAPS Convergence is the largest and most recognized annual gathering of global regulatory affairs professionals. Convergence brings together representatives of industry, regulatory bodies, research, academia, and clinical organizations that are directly involved in managing the regulatory process and aligning science, regulation, and business strategy.

FDA Forecast: What the FDA has Left to Do in its Sprint to the End of 2024

August 27, 2024 | AVAILABLE ON-DEMAND

Alexander Gaffney, Laura DiAngelo

The FDA has been incredibly busy throughout 2024, with the release of several major regulations and guidance documents. But as busy as the agency has been, there’s still much that it has planned between now and the end of the calendar year.

Join AgencyIQ’s research team for a fast-paced, lively, in-depth and informative webinar looking at the guidance, regulations, projects, commitments, and political pressures that the FDA still has on its plate in 2024, and what it means for the life sciences industry.

A Deep Dive into FDA’s new Diversity Action Plan Draft Guidance

July 30, 2024 | AVAILABLE ON-DEMAND

Alexander Gaffney, Laura DiAngelo, Rachel Coe, Amanda Conti

In late June, FDA published a long-awaited and highly anticipated draft guidance document on Diversity Action Plans. Once finalized, the document will have sweeping impacts on sponsors of pharmaceutical, biopharmaceutical, and medical device products, and companies have a short window of time to make suggestions to the FDA on what improvements to make.

Join AgencyIQ’s research team for a fast-paced, lively, in-depth and informative webinar looking at the guidance, how it would affect the life sciences industry, areas where industry is likely to request changes, potential implementation challenges, and more. We will also be available to answer questions about the guidance during the webinar.

EU Chemical Priorities in the Second Half of 2024 and Beyond

July 16, 2024 | AVAILABLE ON-DEMAND

Scott Stephens, Alexander Gaffney

As the incoming Commission slowly takes shape post-elections, Europe’s chemical regulators have remained busy formulating their priorities for the next year and beyond.

Join AgencyIQ’s regulatory experts, Scott Stephens and Alexander Gaffney, for a deep dive into the plans ECHA and the Commission services are considering, including follow-up actions to the Integrated Regulatory Strategy (IRS) and Joint Evaluation Action Plan (JEAP), related enforcement initiatives, and more.

What the 2024 Election Means for the FDA

June 25, 2024 | AVAILABLE ON-DEMAND

Alec Gaffney, Laura DiAngelo

The 2024 Presidential Election is just five months away, and its outcome is likely to have significant impacts on the Food and Drug Administration and its regulation of medical products.

In this fast-paced, informative and lively webinar, AgencyIQ’s regulatory experts will present an objective viewpoint into how the results of the Presidential and Congressional elections could have wide-ranging effects on FDA’s authority, regulatory agenda, and oversight. We’ll also provide analysis of which things are likely to stay the same, which actions have bipartisan support, and provide insights into how FDA typically fares in an election year.

Halfway Through 2024: EPA Regulation at a Crossroads

June 11, 2024 | AVAILABLE ON-DEMAND

Walker Livingston, Alexander Gaffney

The EPA has been busy, issuing a wide range of important regulations in the first half of the year. In this AgencyIQ deep dive, Walker Livingston and Alexander Gaffney will explain what the agency has done so far this year and what it plans to do in the lead-up to the election and potential changeover in presidential administration.

AgencyIQ attending DIA 2024 Global Annual Meeting

June 16, 2024 | INDUSTRY EVENT

Alexander Gaffney, Casey Miles, Joshua Sztorc, Rachel Gartlan

The AgencyIQ Team will be attending the DIA 2024 Global Annual Meeting, at The San Diego Convention Center, in San Diego, CA. The conference will be covering the most pressing topics in the life sciences field, discuss innovative solutions, and provide networking opportunities. The AgencyIQ Team will be attending sessions as well exhibiting at booth #1939.

FDA’s Laboratory Developed Test (LDT) Final Rule: What it Means for Regulated Industry

May 22, 2024 | AVAILABLE ON-DEMAND

Alexander Gaffney, Laura DiAngelo

The FDA recently finalized its long-expected rule to re-configure regulatory oversight for laboratory developed tests (LDTs), setting off a torrent of work for the agency (and industry) and raising significant questions about what implementation of the final rule will look like.

In this fast paced, informative webinar, AgencyIQ will provide a deep-dive on the rule itself, as well as key takeaways not just for LDT stakeholders, but the potential anticipated impacts on the diagnostics, medical devices, pharmaceutical and biopharmaceutical sectors.

AgencyIQ attending RAPS Regulatory Intelligence Conference

June 6, 2024 | INDUSTRY EVENT

Alexander Gaffney, Laura DiAngelo

The AgencyIQ Team will be attending RAPS Regulatory Intelligence Conference, at Hilton Baltimore BWI Airport, in Baltimore, MD. This conference will explore key regulatory affairs topics in a collaborative and engaging environment.

What’s Next for Chemicals Policy After the EU Parliamentary Elections?

May 14, 2024 | AVAILABLE ON-DEMAND

Scott Stephens, Rayan Bhargava, Alexander Gaffney

The current direction of EU chemicals policy hangs in the balance as European citizens prepare to cast their ballots in the upcoming EU-wide parliamentary elections this June. Their outcome will determine the composition of the new Commission and, consequently, shape the agenda for regulating chemicals for the next five years.

Join AgencyIQ’s chemicals regulatory experts, Scott Stephens and Rayan Bhargava, for a lively discussion of the main drivers of EU chemicals regulation in the second half of this year, including the ongoing universal PFAS restriction proposal, the Commission’s exploration of substitution planning, and its newly unveiled communication on the essential use concept.

Halfway Through FFY2024: What’s Left on FDA’s List?

April 23, 2024 | AVAILABLE ON-DEMAND

Alexander Gaffney, MS, RAC, Laura DiAngelo, MPH

Halfway through federal fiscal year 2024, the FDA has released myriad new guidance, policies and regulations with significant impact on the life sciences industry – while still more policies are outstanding in the second half of this fiscal year.

In this fast-paced, lively and informative webinar, AgencyIQ’s regulatory experts will provide in-depth analyses of what’s coming next in regulated medical product policy, covering issues related to related to pharmaceuticals, biopharmaceuticals, medical devices, digital health technologies and diagnostics.

The webinar will focus on what to-do’s remain on FDA’s list as it heads into the back end of federal fiscal year 2024, including new (and outstanding) guidance documents, user fee commitments, and regulations – as well as updates on Congressional activity that could impact the agency and regulated industry.

The State of TSCA: A comprehensive deep dive

April 17, 2024 | AVAILABLE ON-DEMAND

Walker Livingston, Alexander Gaffney

This engaging and informative webinar will delve deep into the EPA’s administration of the Toxic Substances Control Act (TSCA) and look ahead to what we can expect for the future. AgencyIQ’s chemicals regulatory experts will thoroughly explain the status of current risk assessments and management actions, as well as detail the agency’s plans for future rules and procedures.

European Life Sciences Regulatory Review: Q1 2024

March 26, 2024 | AVAILABLE ON-DEMAND

Alexander Gaffney, Corey Jaseph, Kirsten Messmer

European regulators, including the EMA, MHRA and Swissmedic, have been busy in the first quarter of 2024. Already, the life sciences industry has new regulations, guidelines, policies and even legislation to contend with, including new developments related to the MDR and IVDR, efforts to transform MHRA’s regulatory frameworks, and pending efforts to launch a new pharmaceutical regulatory system.

Join AgencyIQ’s regulatory experts for a fast-paced, lively and informative webinar covering the latest European regulatory issues related to related to pharmaceuticals, biopharmaceuticals, medical devices, digital health technologies and diagnostics.

AgencyIQ attending 2024 GlobalChem Conference

March 25, 2024 | INDUSTRY EVENT

Patricia Iscaro, Casey Miles, Joshua Sztorc, Mitchell Cain, Anastasiia Romanova

The AgencyIQ Team will be attending the 2024 GlobalChem Conference, hosted by The American Chemistry Council at Grand Hyatt Washington in Washington, DC. The conference will be covering developments in global chemicals management. The AgencyIQ Team will be attending sessions as well exhibiting at booth #103.

AgencyIQ at POLITICO’s Health Care Summit

March 13, 2024 | AVAILABLE ON DEMAND

Join POLITICO’s annual Health Care Summit where we will discuss the future of medicine, including the latest in health tech, new drugs and brain treatments, diagnostics, health equity, workforce strains and more. And in this era of intense political contests, what are the most viable policy and regulatory solutions in Washington and beyond for the patients and individuals impacted by these decisions?

The Future of EU Hazard Communication: Industry Implications of a Revised CLP

March 12, 2024 | AVAILABLE ON DEMAND

Scott Stephens, Rayan Bhargava, Alexander Gaffney

With the long-awaited revision of the CLP Regulation between provisional agreement and formalization, AgencyIQ will present the changes industry can expect concerning hazard communication compliance.

From new rules combatting greenwashing, to the integration of new hazard classes, and the further incorporation of chemicals bought online and in bulk, the CLP’s new provisions affect everyone. Join AgencyIQ’s EU chemical experts Scott and Rayan as they analyze the way forward for one of the bloc’s flagship chemical regulations.

FDA Guidance and Policy Review: January and February 2024

February 27, 2024 | AVAILABLE ON-DEMAND

Alexander Gaffney, Laura DiAngelo

Just two months into 2024, and the FDA is releasing new guidance, policies and regulations that have the potential to transform large parts of the life sciences industry.

In this fast-paced, lively and informative webinar, AgencyIQ’s regulatory experts will provide in-depth analyses of the latest developments in regulated medical product policy, covering issues related to related to pharmaceuticals, biopharmaceuticals, medical devices, digital health technologies and diagnostics.

The webinar will focus on what the agency has accomplished so far in 2024 and provide a preview of the regulatory actions and activities that we expect to hear more about in the coming weeks.

Navigating Changes in U.S. Cosmetics Regulation (MoCRA)

February 13, 2024 | AVAILABLE ON-DEMAND

Patricia Iscaro, Walker Livingston, Alexander Gaffney

The U.S. cosmetics industry is experiencing the most significant change since 1938 with the enactment of the Modernization of Cosmetics Regulation Act (MoCRA).

In this fast-paced, lively, and informative webinar, AgencyIQ’s regulatory research team will be reviewing new requirements for the registration of cosmetic facilities and listing of cosmetic products. The team will also be looking at labeling, the launch of the Cosmetics Direct portal and related guidance and forms. We will review the proposed rules on substances that are fragrance allergens, requirements for testing and detecting asbestos in talc, PFAS in cosmetics, and the GMP rule. Finally, the team will compare state actions to restrict or ban substances that have been intentionally or unintentionally added to cosmetic products above and beyond the 11 substances that are currently banned or restricted by the FDA.

What FDA has Done (and Will do) in Q1 2024

January 30, 2024 | AVAILABLE ON DEMAND

Alexander Gaffney, MS, RAC, Laura DiAngelo, MPH

Just weeks into the new calendar year, and the FDA is already unveiling major new and final regulatory policies.

In this fast-paced, lively and informative webinar, AgencyIQ’s regulatory experts will provide in-depth analyses of the latest developments in regulated medical product policy, covering issues related to related to pharmaceuticals, biopharmaceuticals, medical devices and diagnostics.

The webinar will focus on what we’ve seen so far this year, the deadlines that FDA has missed (but hasn’t forgotten), and what is coming next – including the FDA’s long-awaited policies on diversity in clinical research, the medical device quality system revamp, and the impact that Congress’ activities will have on the FDA in the near-term.

One Substance, One Assessment: The EU’s streamlining of chemical regulation processes

January 17, 2024 | AVAILABLE ON DEMAND

Scott Stephens, Rayan Bhargava

Kick off the new year with a fast-paced, engaging, and informative webinar where the AgencyIQ EU chemicals research team will analyze the trio of legislative proposals unveiled by the European Commission as part of its “one substance, one assessment” ambitions.

Envisaged as a way to streamline chemical regulatory processes as the sector is expected to balloon throughout the decade, this flurry of chemical reforms establishes a common data platform and reallocates regulatory responsibilities between EU agencies. As the co-legislators reckon with these three proposals, the AgencyIQ team will be presenting our own analysis and explaining the significance to industry of the EU’s latest attempt at chemical reform.

FDA Forecast 2024: What we expect the FDA to do in 2024

December 14, 2023 | AVAILABLE ON DEMAND

Alexander Gaffney, Laura DiAngelo, Kari Oakes, Rachel Coe, Amanda Conti

As 2023 draws to a close, regulatory professionals are looking ahead to 2024 and asking a simple question: What’s on FDA’s 2024 regulatory agenda? While no one has a crystal ball, AgencyIQ’s regulatory experts have a proven track record of anticipating and predicting what the FDA will do next based on our extensive knowledge of FDA policy documents, legislative requirements, regulatory trends and more.

In this fast-paced, lively and informative webinar, AgencyIQ’s regulatory experts will provide an evidence-based set of predictions about what we can expect from the FDA next year related to pharmaceuticals, biopharmaceuticals, medical devices, diagnostics and dietary supplements.

Looking ahead to 2024: Regulatory Forecast for the U.S. and the EU

December 12, 2023 | AVAILABLE ON DEMAND

Patricia Iscaro, Scott Stephens, Walker Livingston, and Rayan Bhargava

Join the AgencyIQ chemicals team for a free, informative, and engaging webinar covering our 2024 regulatory forecast for the U.S. and the EU.

Our webinar will cover expected regulatory developments for PFAS and the proposed National Drinking Water Regulation, the finalization of EPA Method 1633, CERCLA and RCRA regulation of PFAS, and various state PFAS regulations going into effect. We will also be discussing upcoming minimum risk pesticide regulations, neonicotinoids interim decisions, and more.

On the EU side, we will be forecasting developments having to do with the universal PFAS restriction, CLP Regulation, and a smattering of happenings from across the rest of the regulatory spectrum. In a Parliamentary election year, what is likely to happen in the EU is just as significant as what is omitted from the bloc’s 2024 planning documents.

European Regulatory Update: What pending and ongoing changes mean for pharma and medtech companies

November 28, 2023 | AVAILABLE ON DEMAND

Alexander Gaffney, Kari Oakes, Kirsten Messmer, Corey Jaseph

The European regulatory environment is in the midst of significant changes – both active and proposed – leaving regulatory professionals scrambling to keep up and predict what comes next.

In this fast-paced, lively and informative webinar, AgencyIQ’s regulatory research team will provide a breakdown and status update of topics of interest to pharmaceutical, biopharmaceutical, medical device and diagnostics professionals, including:

The ongoing re-write of the Pharmaceutical Legislation
The new regulation on substances of human origin (SoHOs)
International recognition procedure proposals in the U.K.
EMA’s new fees regulation
What the European Commission and Medical Device Coordination Group have been up to recently
The Medical Device Regulation extension
Upcoming MDR and IVDR deadlines and developments, including related developments in the U.K. and Switzerland

Attendees of the webinar will receive a succinct, actionable overview of the regulations, policies and legislative developments we expect to see in the months ahead.

What FDA’s Proposed LDT Rule Could Mean for the Life Sciences Industry

November 15, 2023 | AVAILABLE ON DEMAND

Laura DiAngelo, Corey Jaseph, Alexander Gaffney

The FDA recently unveiled a proposed rule that would dramatically change how many Laboratory Developed Tests (LDTs) are regulated. As proposed, the rule would codify the agency’s viewpoint that LDTs are in fact medical devices, and are therefore subject to FDA’s device regulatory framework, including pre-market review.

While the rule remains open for review, it is already generating intense debate and concern among some industry stakeholders.

In this fast-paced, lively and informative webinar, AgencyIQ’s regulatory researchers will explain how FDA’s LDT proposed rule is intended to function and the potential effects it would have on the LDT industry, diagnostics industry, pharmaceuticals and biotechnology industries, and on ongoing Congressional efforts to pass reforms. We will also answer questions from live attendees.

The state of single-use plastics in the U.S., Canada, and the EU

November 14, 2023 | AVAILABLE ON DEMAND

Patricia Iscaro, Walker Livingston, Scott Stephens, and Rayan Bhargava

Join us for a fast-paced, informative webinar where the AgencyIQ chemical research team will cover the latest regulatory happenings on the single-use plastics (SUPs) in the U.S., Canada, and the EU.

U.S. regulatory updates on SUPs will include the most recent version of the House’s Break Free from Plastic Pollution Act, California, and other state bans of SUPs.

The team will provide a thorough review of Canada’s SUP restrictions and ban.

The team will also analyze the EU’s ongoing ambition to phase out single-use plastics and highlight member-state implementations of Directive 2019/904/EU. We will breakdown the 27-member bloc’s Packaging and Packaging Waste Regulation that is currently winding its way through the EU’s legislative procedure and evaluate the implications of the recent flurry of EU microplastics legislation concerning intentionally added components and plastic pellets that are the building blocks of all plastics.

FDA End-of-Year Preview: What the FDA has left to do in 2023

October 25, 2023 | AVAILABLE ON DEMAND

Alexander Gaffney, MS, RAC, Laura DiAngelo, MPH, and Rachel Coe, MSC

The Food and Drug Administration is starting its end-of-calendar-year sprint, with much to accomplish before the start of 2024.

In this fast-paced, lively and informative webinar, AgencyIQ’s regulatory and policy experts will provide regulatory professionals working in the life sciences industry with a succinct, actionable overview of the guidance documents, regulations, policies and legislation we expect to see by the end of the year.

Navigating EPA’s PFAS Reporting Rule and Latest PFAS Definition

October 24, 2023 | AVAILABLE ON DEMAND

Patricia Iscaro and Walker Livingston

The EPA has finalized its new reporting rule and definition for PFAS under TSCA. The rule represents one of the most important and wide-ranging rules for not only just the chemical industry, but for any industry that deals with PFAS, as well as importers and retailers.

In this fast-paced, informative webinar AgencyIQ’s chemical regulatory experts will drill down into the EPA’s new TSCA PFAS reporting rule and examine its new enforceable definition of PFAS.  We will provide actionable insights regulatory professionals need to know, including a detailed explanation of who the law affects and who it doesn’t, what must be reported (CBI), relevant articles, the timeline, and more.