00:00 - 00:03 | Sir,I have some bad news. |
00:04 - 00:05 | It is regarding the eCTD. |
00:05 - 00:07 | It will be mandatory in Canada. |
00:08 - 00:12 | We will have to change our processes. |
00:12 - 00:15 | Health Canada accepts them now. |
00:17 - 00:19 | That's OK, we can put it it off. |
00:19 - 00:21 | Keep doing paper submissions. |
00:24 - 00:26 | Sir... |
00:27 - 00:28 | Umm.... |
00:31 - 00:33 | GDM eStrategy is now involved. |
00:34 - 00:36 | They are planning to onboard us. |
00:53 - 00:58 | Everyone who works in paper, get out now. |
01:13 - 01:15 | This is bullshit!!! |
01:15 - 01:17 | I have been doing paper submissions for years! |
01:18 - 01:23 | Same with all of the idiots that just left. |
01:25 - 01:28 | I will miss doing paper submissions. |
01:29 - 01:31 | Don't cry. |
01:31 - 01:34 | eCTD! That's not easy! |
01:34 - 01:37 | It's more damn work for everyone! |
01:37 - 01:40 | We have to change EVERYTHING! |
01:40 - 01:42 | Sir, GDM will help us. |
01:42 - 01:46 | I don't want any help! I am furious. |
01:46 - 01:48 | We've been given plenty of notice. |
01:48 - 01:52 | Screw that and screw Health Canada. |
01:53 - 01:54 | I've heard all of the reasons. |
01:56 - 01:57 | "Electronic is the way to go" |
01:57 - 02:00 | "It's easy to submit through a gateway." |
02:00 - 02:03 | "It's easier and better for reviewers" |
02:04 - 02:08 | Are you kidding me? |
02:08 - 02:13 | People will have to do different things. |
02:14 - 02:16 | They might have to try something new! |
02:17 - 02:21 | All because we have to follow the damn guidance! |
02:27 - 02:29 | I know what I am doing. |
02:30 - 02:34 | Paper submissions are a part of my soul. |
02:34 - 02:36 | I can't support something I don't understand |
02:41 - 02:42 | Paper is easy... |
02:43 - 02:47 | Anyone can operate a copier and make binders. |
02:48 - 02:53 | How will we make last minute changes? |
02:54 - 02:56 | We can't just add pages! |
02:56 - 02:59 | What will we do with all of the White-Out!?! |
03:00 - 03:02 | And don't mention the page stamper! |
03:04 - 03:07 | It's ok - you will learn to use the viewer. |
03:14 - 03:16 | So we will have to get a team together. |
03:19 - 03:23 | ... meet with these GDM people. |
03:25 - 03:26 | Ugh. |
03:31 - 03:33 | We'll have to learn new tools. |
03:40 - 03:46 | If GDM is willing to help us, so be it. |
03:46 - 03:49 | We will have to work differently. |
03:53 - 03:56 | Arrange a meeting... |