Live and On-Demand Events

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A Deep Dive into FDA’s new Diversity Action Plan Draft Guidance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In late June, FDA published a long-awaited and highly anticipated draft guidance document on Diversity Action Plans.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.

Regulation of pesticides in the U.S. and the E.U.

September 19, 2023 | AVAILABLE ON DEMAND

Patricia Iscaro, Scott Stephens, Walker Livingston, Rayan Bhargava

Join the AgencyIQ Chemicals research team for a webinar focused on pesticide policy in the U.S and EU. In the U.S, the research team will discuss the EPA’s proposed herbicide strategy, the Farm Bill, PRIA 5, and antimicrobials. While on the EU side, our team will look at the status of the proposed legislation on the sustainable use of plant protection products (PPPs), significant regulatory developments at E.U. member-state level affecting the agrochemicals sector, and an update on the reauthorization of the active substance glyphosate.

This dynamic webinar will bring you up to speed on the complex landscape of pesticide regulations on both sides of the Atlantic.

AgencyIQ Pharmaceutical and Biotech Update: Unpacking FDA’s Latest Regulatory Developments

September 13, 2023 | AVAILABLE ON DEMAND

Alexander Gaffney, Rachel Coe

What were CDER and CBER up to this summer, and what do those developments mean for the pharmaceutical and biopharmaceutical industries?

Join AgencyIQ’s regulatory policy and intelligence experts for a fast-paced, lively, and informative look at recent regulatory developments, including new guidance, policies, compliance actions and regulatory enforcement discretion activities.

REACHing for the finish: EU and US regulatory projections for Q4 2023

August 22, 2023 | AVAILABLE ON DEMAND

Patricia Iscaro, Scott Stephens, Walker Livingston, Rayan Bhargava

The AgencyIQ Chemicals research team expects a whirlwind of activity as the U.S. and the EU have much to accomplish as 2023 moves from Q3 through Q4.

In this fast-paced dynamic webinar the AgencyIQ research team will explain what is front and center in the EU – the REACH revision, the close of the consultation on the universal PFAS restriction, as well as a possible approval for glyphosate, among others. On the U.S. side, top of mind is also PFAS, both on the legislative and regulatory fronts (RCRA/EPCRA/TSCA), the long-awaited hazard communication standards (HCS), TSCA risk management actions and SNURS, as well as pesticide mitigation strategies, among several other issues. The team will also discuss what will not happen before the close of 2023.

Webinar attendees will get a heads’ up on these year-end actions which will provide them with the runway needed to prepare for upcoming changes to their industries.

Regulatory Update: What’s New for Device and Diagnostics Regulation in the US and EU?

August 9, 2023 | AVAILABLE ON DEMAND

Alec Gaffney, Laura DiAngelo, Corey Jaseph

There has been a torrent of recent changes in the U.S. and E.U. related to medical device and diagnostics regulation. From new frameworks and guidance to novel pilot programs and approaches, there is a lot for regulatory affairs professionals to track.

But what should they expect next from the US Food and Drug Administration and European regulatory bodies? In this lively and informative webinar, AgencyIQ’s medical device and diagnostics experts Laura DiAngelo and Corey Jaseph will provide a deep dive into the policies, regulations, legislation and approaches they’re expecting to see next and what it could mean for device and diagnostics companies.

Extended Producer Responsibility

July 18, 2023 | AVAILABLE ON DEMAND

Patricia Iscaro, Walker Livingston, and Rayan Bhargava

Extended producer responsibility (EPR) has been around for a long time in the European Union and has been gaining traction in the U.S. at the state level. EPR starts with the design of a product through the end of its useful life (cradle to grave) shifting the responsibility for these products to producers.

Join us for a fast-paced, informative webinar where the AgencyIQ Team will look at EPR programs in the U.S. at the state level and EPR efforts at the federal level. We will also be covering EPR schemes in the EU, dedicating attention to current regulatory developments within the context of the bloc’s commitments to the Chemicals Strategy for Sustainability and in pursuit of a more circular economy

What do we expect the FDA to do in Q3 2023?

July 12, 2023 | AVAILABLE ON DEMAND

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

There is much that the FDA expects to do in July, August and September this year – and much that the life sciences industry needs to prepare for.

New legislation, reauthorized user fee programs and updated regulatory agendas are driving these changes, which are likely to result in one of the busiest periods for regulatory policymaking in the last decade.

In this lively, fast-paced and informative webinar, AgencyIQ’s research staff will explain what regulatory actions the life sciences industry can expect in the third quarter of 2023, including new guidance documents, regulations, reports, pilot programs and more. Webinar attendees will benefit from a big-picture look at FDA’s policymaking agenda, as well as specific details about those policies and which ones could have an outsized impact on specific industry sectors, helping them to prepare for an especially active period of consequential change.

PFAS Testing in the U.S. and the EU

June 14, 2023 | AVAILABLE ON DEMAND

Patricia Iscaro, Walker Livingston, Scott Stephens, Rayan Bhargava

The regulation of per- and polyfluoroalkyl substances (PFAS) is constantly evolving. Bans and restrictions on these “forever chemicals” go hand-in-hand with how to test for PFAS in water, soil, and products such as pesticides (containers).

In this fast-paced, informative webinar the AgencyIQ team will review PFAS testing methods in the U.S. and the EU. We will explore how PFAS testing methods are utilized in various media, their effects, and the implications for the chemical industry. We will also discuss future method development, highlighting what regulatory professionals may expect, what they should keep an eye on, and potential industry impact.

FDA’s New Decentralized Trials Guidance: What Regulatory Professionals Need to Know

June 6, 2023 | AVAILABLE ON DEMAND

Alexander Gaffney, Laura DiAngelo

The FDA recently published its long-awaited draft guidance document on decentralized clinical trials for drugs, biological products and medical devices, offering companies a look at how they can best leverage decentralized approaches to benefit their clinical development programs.

In this fast-paced, lively and informative webinar, AgencyIQ will provide an overview of the agency’s guidance, with a special emphasis on areas of interest and potential concern for the life sciences industry. We’ll also explore how the document works in tandem with other FDA policies, what companies might be able to leverage already, and what industry should expect next as FDA works to finalize the document.

The Ecodesign for Sustainable Products Regulation: Chemicals Supply Chain Implications

May 9, 2023 | AVAILABLE ON DEMAND

Scott Stephens, Rayan Bhargava

The Ecodesign for Sustainable Products Regulation (ESPR) represents one of the central ambitions of the European Commission’s New Circular Economy Action Plan that was unveiled in 2020. Fast forward to 2023, this important initiative is now taking concrete shape. Join AgencyIQ experts Scott and Rayan for a webinar covering an overview of the ESPR proposal, its current status in the EU’s policy-making process, and the possible impacts it could have on the chemicals sector up and down the value chain.

E.U. Forecast: What’s next for the E.U. Pharma Legislation

May 2, 2023 | AVAILABLE ON DEMAND

Kirsten Messmer, Kari Oakes, Alexander Gaffney

As the life sciences industry holds its breath and waits to see if the long-promised revision of the E.U. Pharmaceutical Legislation comes out (as promised) on April 26th, AgencyIQ wants to talk about the proposal we get (if it comes out) or what we’re expecting (if it doesn’t).

Join AgencyIQ for a webinar focused on the Pharmaceutical Legislation, including what’s driving the changes, what the Commission has proposed, industry’s reactions to the proposals so far, and its potential impacts on the life sciences industry. We’ll cover a wide range of impact areas, including data exclusivity, environmental risk assessments, and the development of products addressing an unmet medical need.

What’s ahead for FDA in Q2 and Q3?

April 4, 2023 | Available on demand

Alec Gaffney, Laura DiAngelo

The FDA has a lot on its to-do list this year, and regulatory professionals in the life sciences need to be ready for what comes next. In this free webinar, AgencyIQ’s regulatory experts provide a detailed overview of what the FDA has planned for Q2 and Q3 2023 and what we’re likely to see next. We explain which guidance documents, frameworks, meetings and events are upcoming, how best to prepare for them, and what we already know.

• Knowing what the FDA is statutorily required to accomplish over the next 6 months
• Knowing what the FDA has committed to doing over the next 6 months
• What the FDA is working on independently of any deadlines
• The opportunity to ask questions of AgencyIQ’s research team

States of Flux: PFAS Actions Across the U.S. in 2023

March 7, 2023 | Available on demand

Patricia Iscaro, Walker Livingston

In this free webinar, AgencyIQ’s chemical regulatory experts provide a thorough review of U.S. states’ 2023 actions on perfluoroalkyl and polyfluoroalkyl substances (PFAS) in:

• Water
• Food packaging
• Textiles
• Firefighting foam
• Cosmetics
• Litigation

We also review the implications of these actions, discuss next steps, and highlight what we think regulatory professionals need to keep an eye on.

FDA’s 2023 Guidance Agenda: What Regulatory Professionals Need to Know

February 22, 2023 | Available on demand

Alec Gaffney, Laura DiAngelo

AgencyIQ is often asked about what the FDA is working on, and what it could mean for the life sciences industry. Here’s your chance to learn more. In this free webinar, AgencyIQ’s regulatory experts provide an overview and review of the FDA guidance documents that are under development and that we think regulatory professionals need to keep an eye on. We also highlight notable additions to FDA’s various guidance agendas this year, detail which documents are due to arrive soon, indicate which documents are required under the recent user fee commitment letters and FDORA legislation, and make note of certain recent draft guidance documents that we think could be due for release in the coming year.

Attendees will benefit from:

• Learning which new guidance could affect their regulatory strategy
• Learning about when specific documents of interest are likely to be published
• An opportunity to receive AgencyIQ’s guidance document development database

What you need to know about FDORA, the new FDA reform law

January 24, 2023 | Available on demand

Alec Gaffney

On December 29, 2022, President Joe Biden signed into law one of the most consequential pieces of FDA-related legislation in the last decade. The Consolidated Appropriations Act of 2023 contains extensive provisions related to how pharmaceuticals, biologics, medical devices and other health care products are regulated. The bulk of these reforms are contained in a section called the Food and Drug Omnibus Reform Act, or FDORA. In this hour-long webinar, AgencyIQ’s research team explains what you need to know about this landmark piece of legislation, its impacts on the life sciences industry, and what we’ll be watching for next as FDA begins to implement FDORA.