What s your regulatory IQ, part 6

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Here s the sixth and final installment of this session from the Alliance for CME conference last week. Can you tell I liked this session?

Question: Must the distribution of invitations to a CME event or those used to create awareness of an enduring material by sales reps be supplemented by a general mailing to the intended audience?

1. Yes

2. It s up to the provider

3. The guidelines don t address this

The audience was pretty split on this one: 30 percent for #1, 45 percent for #2, and 25 percent for the third option, which is the correct one, according to the presenters.

Question: Can a sales rep pick up faculty from an airport or train station?

1. Depends on how desperate the rep is

2. No, guidelines prohibit this

3. Yes, but the CME provider has to request it

Fifty-nine percent of the audience went for #3, with 40 percent voting for #2 and 1 percent were wise guys. The presenters said that most companies have their own policies on this, and that there might be some risk that they d try to control the content. "There s no real guideline on it. You have to make policy based on the perception perspective," one presenter said.

Question: Is it OK to provide social activities prior to or after a CME activity?

1. Yes, if it doesn t take precedence over the CME

2. Yes, if it furthers the attendees learning process

3. Yes, as long as it is not used as an enticement to attend the event

4. All of the above

The last is the correct answer, according to the presenters.

Question: Does the FDA or OIG regulate CME?

1. Always

2. Independent CME is not subject to FDA and OIG

3. CME is only subject to ACCME rules

The pharma presenter said that, regardless of the true answer, for his company, the reality is #1. "If they open an investigation, everything comes into play."

Question: Can a CME provider give the attendee list to a commercial supporter?

1. It depends on how they intend to use it

2. Can t do it

3. They can as long as no contact information is provided.

The audience voted 40 percent for #1, 19 percent for #2, and 42 percent for #3. An ACCME representative in the audience said, "ACCME doesn t have a policy on this, but the Internet guides say you need to have a confidentiality policy. It s a matter of accreditation versus good practice." An audience member said they provide a summary of the evaluations, not the sign-in sheet. The pharma presenter said "We wouldn t ask for that because the FDA might think we re going to use it to track scrips or something."

To comment on this post, click on "comments" below. To receive a weekly update, e-mail Sue.

Here s the sixth and final installment of this session from the Alliance for CME conference last week. Can you tell I liked this session?

Question: Must the distribution of invitations to a CME event or those used to create awareness of an enduring material by sales reps be supplemented by a general mailing to the intended audience?

1. Yes

2. It s up to the provider

3. The guidelines don t address this

The audience was pretty split on this one: 30 percent for #1, 45 percent for #2, and 25 percent for the third option, which is the correct one, according to the presenters.

Question: Can a sales rep pick up faculty from an airport or train station?

1. Depends on how desperate the rep is

2. No, guidelines prohibit this

3. Yes, but the CME provider has to request it

Fifty-nine percent of the audience went for #3, with 40 percent voting for #2 and 1 percent were wise guys. The presenters said that most companies have their own policies on this, and that there might be some risk that they d try to control the content. "There s no real guideline on it. You have to make policy based on the perception perspective," one presenter said.

Question: Is it OK to provide social activities prior to or after a CME activity?

1. Yes, if it doesn t take precedence over the CME

2. Yes, if it furthers the attendees learning process

3. Yes, as long as it is not used as an enticement to attend the event

4. All of the above

The last is the correct answer, according to the presenters.

Question: Does the FDA or OIG regulate CME?

1. Always

2. Independent CME is not subject to FDA and OIG

3. CME is only subject to ACCME rules

The pharma presenter said that, regardless of the true answer, for his company, the reality is #1. "If they open an investigation, everything comes into play."

Question: Can a CME provider give the attendee list to a commercial supporter?

1. It depends on how they intend to use it

2. Can t do it

3. They can as long as no contact information is provided.

The audience voted 40 percent for #1, 19 percent for #2, and 42 percent for #3. An ACCME representative in the audience said, "ACCME doesn t have a policy on this, but the Internet guides say you need to have a confidentiality policy. It s a matter of accreditation versus good practice." An audience member said they provide a summary of the evaluations, not the sign-in sheet. The pharma presenter said "We wouldn t ask for that because the FDA might think we re going to use it to track scrips or something."

To comment on this post, click on "comments" below. To receive a weekly update, e-mail Sue.

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